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Industry Perspective on Streamlining Information Sharing
Veeva Systems Inc
/@VeevaSystems
Mar 4, 2021
This video provides an in-depth exploration of the critical need to streamline information sharing and collaboration within clinical trials, drawing insights from the 2020 Veeva Unified Clinical Operations Survey. Presented by Jason Methia, VP of Site Engagement Strategy at Veeva Systems, the discussion highlights how legacy processes for data sharing have long been a significant barrier to modernizing clinical trials, a challenge further exacerbated and accelerated by the COVID-19 pandemic. The core issue revolves around inefficient information exchange between sponsors, Contract Research Organizations (CROs), and clinical research sites, leading to increased administrative burden, higher costs, and a diversion of focus from strategic, patient-oriented activities. The presentation details the evolution of technology adoption in clinical trials, noting the initial positive step of moving from paper to electronic systems within sponsors and CROs. However, this progress has introduced unintended consequences: the independent implementation of various systems by different functional areas often creates application and process silos, or necessitates complex internal integrations. This fragmentation has prompted an industry-wide movement towards a unified clinical trial system landscape, with 98% of survey respondents recognizing this need and 83% actively pursuing or planning such initiatives. This internal unification, while beneficial, is identified as only one piece of the puzzle, as it fails to address the crucial external digital engagement and automated information flow between sponsors, CROs, and the tens of thousands of clinical research sites where most trial activity occurs. The video further elaborates on why external information sharing is paramount: clinical trials are growing larger and more complex, increasing reliance on CROs and sites, and generating unprecedented amounts of information that requires seamless collaboration. The current methods of interaction—predominantly email (78%), paper (40%), and investigator portals (38%)—are shown to be inefficient and costly. These methods are characterized by manual environments, extensive rework, and disconnected system landscapes at the sponsor level. Investigator portals, despite being a recent attempt to improve collaboration, have largely failed to deliver desired results because they typically don't cover all aspects of site engagement, require multiple integrations, and are not true site solutions designed to support a site's day-to-day operations. The long-term disruption of COVID-19 is expected to accelerate the adoption of more digital, automated, and connected forms of collaboration, pushing the industry towards full system interoperability not just within organizations, but across the entire ecosystem from sponsor to site and even to patient solutions. Key Takeaways: * **Persistent Challenges in Clinical Trial Collaboration:** Legacy processes for data sharing and collaboration have historically been significant barriers to modernizing clinical trials, a problem intensified by the COVID-19 pandemic which highlighted the urgent need for digital transformation. * **Impact of Fragmented Technology Adoption:** While the industry has moved from paper to electronic systems, the independent adoption of various clinical trial applications by different functional areas within sponsors and CROs has created application and process silos, leading to complex internal integrations and inefficiencies. * **Industry Shift Towards Unified Systems:** There is a strong industry consensus on the need for unified clinical trial systems and processes, with 98% of respondents reporting this need and 83% having or planning initiatives to consolidate clinical applications within their organizations, often moving to a platform strategy across multiple functional areas. * **Limitations of Internal Unification:** While internal unification within a sponsor or CRO is a positive step, it does not fully address the critical challenge of digitally engaging, automating, and connecting information flow between sponsors/CROs and the vast network of clinical research sites. * **Drivers for Improved Information Exchange:** The primary drivers for simplifying information exchange with study partners include reducing manual processes (75%), increasing visibility and oversight (58%), achieving faster study execution (58%), and improving study quality (58%). * **Inefficiency of Current Communication Methods:** Email (78%), paper (40%), and investigator portals (38%) remain the predominant methods for information exchange between sponsors/CROs and sites, all of which contribute to manual environments, rework, and disconnected system landscapes. * **Shortcomings of Investigator Portals:** Investigator portals, while intended to improve site collaboration, often fall short because they typically do not cover all aspects of site engagement, require multiple integrations, and are not purpose-built as true site solutions to support a site's day-to-day operations. * **Accelerated Digital Transformation Post-COVID-19:** The COVID-19 pandemic is expected to positively disrupt clinical trials, accelerating the adoption of technology for more virtual and remote trials, and driving the industry towards more digital, automated, and connected forms of collaboration. * **Need for Full System Interoperability:** To truly address the challenges of time and effort in clinical trial information sharing, the industry requires full system interoperability not only within sponsors and CROs but critically, across the entire ecosystem from sponsor to site and even out to patient solutions. * **Focus on High-Value Activities:** The goal of streamlining information sharing is to reduce the high administrative burden and allow the workforce to shift from low-value, high-volume transactional activities to more strategic, high-value trial or patient-oriented activities. Key Concepts: * **Unified Clinical Trial System Landscape:** A strategy where clinical applications across multiple functional areas (e.g., clinical operations, data management, monitoring, startup) are consolidated under one technology platform or roof within a sponsor or CRO. * **Application/Process Silos:** Disconnected systems and workflows that arise when various technologies are implemented independently by different functional areas without a comprehensive system strategy. * **Investigator Portals:** Web-based platforms developed by sponsors or CROs to facilitate interaction and information exchange with clinical research sites, often criticized for not being comprehensive or site-centric. * **Decentralized Clinical Trials (DCTs):** Clinical trials that incorporate virtual or remote elements, allowing some or all trial activities to occur outside traditional site settings, often leveraging technology for patient engagement and data collection. * **System Interoperability:** The ability of different information systems, devices, and applications to access, exchange, integrate, and cooperatively use data in a coordinated manner, both within and across organizational boundaries. Tools/Resources Mentioned: * **Veeva Unified Clinical Operations Survey (2020):** The primary source of data and findings discussed in the video, highlighting industry trends and needs. * **Veeva Systems:** The company channel and speaker's affiliation, indicating their role in providing solutions for clinical operations.
Trial Master File (TMF) Quality Review: Identify and Mitigate Compliance Risk with PhlexTMF
Phlexglobal - a Cencora PharmaLex company
/@Phlexglobal
Mar 3, 2021
This video provides an in-depth exploration of Trial Master File (TMF) Quality Review, demonstrating how Phlexglobal's PhlexTMF software facilitates a systematic and compliant approach. The main purpose of the video is to showcase the exclusive quality review functionality within PhlexTMF, which enables periodic review of TMF content to identify and mitigate compliance risks. The presenter begins by establishing the crucial role of periodic or milestone-based reviews in ensuring a well-formed TMF and robust oversight processes. The core idea is to ensure the TMF tells a clear, collective, and accurate story of the clinical trial, as intended by regulatory guidelines. The video details how reviews are conducted through "packages," which allow for the sampling of documents. The selection of documents for review and the sampling methodology are automated through "review templates." These templates are designed to operationalize an organization's Standard Operating Procedures (SOPs), thereby ensuring that study teams consistently comply with predefined review parameters. The demonstration walks through the process from the perspective of a study manager creating a quarterly review package, naming it, accepting default settings, and then assigning different parts of the review to various members of the study team. This assignment process includes automated notifications, eliminating the need for manual email correspondence and establishing the package as a central command center for tracking review completion. Further into the demonstration, the video shifts to the reviewer's perspective, illustrating how they receive alerts or emails prompting them to complete a review. Upon accessing the review, the system presents a list of selected documents. A specific example involves reviewing a Form 1572 (Statement of Investigator). The system provides built-in checks tailored to the document type, ensuring completeness, correct filing location, and accurate listing of relevant information, such as IRB details. A key feature highlighted is the cross-checking capability, where the system compares information within the document (e.g., sub-investigators listed on the 1572) against existing system records. This allows reviewers to easily identify discrepancies, such as an investigator listed on the form but not known to the system or the TMF. In such cases, the system enables the reviewer to "raise an event" directly, which automatically triggers the collection of required documents for the newly identified individual, streamlining remediation efforts. The video concludes by emphasizing that all review work and findings are collected into package findings reports, providing transparent and reportable remediation efforts, trend identification, and, most importantly, clear, simple evidence for auditors or inspectors that the quality review process is being followed. Key Takeaways: * **Systematic TMF Quality Review:** The video underscores the critical importance of periodic or milestone-based quality reviews of the Trial Master File (TMF) content to ensure consistency, completeness, and accuracy, which are vital for regulatory compliance and telling a clear story of the clinical trial. * **Automation via Review Templates:** PhlexTMF automates the document sampling and review process through configurable "review templates." These templates operationalize an organization's SOPs, ensuring that review parameters are consistently applied and compliance is maintained. * **Centralized Review Management:** The system allows study managers to create "review packages," assign specific review tasks to team members, and track progress from a central command center, significantly improving oversight and reducing manual communication efforts. * **Enhanced Efficiency and Productivity:** By managing all aspects of quality review within a single system, organizations can achieve greater efficiency and productivity, replacing manual processes and spreadsheets with built-in workflows and best practices. * **Risk-Based Approach to Compliance:** The solution facilitates a risk-based approach to TMF Quality Review, aligning with industry guidelines such as ICH E6 (R2), by enabling early identification and resolution of potential issues. * **Early Issue Identification and Mitigation:** The system helps identify and resolve potential TMF issues early in the study lifecycle, thereby eliminating the significant cost and effort associated with rework during inspection preparation or at the end of the study. * **Intelligent Cross-Checking Capabilities:** PhlexTMF offers intelligent cross-checking features, allowing reviewers to compare information within documents (e.g., investigator lists on Form 1572) against system records to identify discrepancies and ensure data consistency. * **Streamlined Discrepancy Resolution:** When discrepancies are found, reviewers can easily "raise an event" within the system, which automatically initiates the process of collecting necessary supporting documents, ensuring prompt and compliant remediation. * **Transparent Reporting and Audit Readiness:** All review findings, queries, and remediation efforts are transparently collected and reported, providing clear, simple evidence to auditors and inspectors that the organization is diligently following its quality review processes. * **Reduced TMF Finalization Effort:** The systematic approach and early issue resolution significantly reduce the time and effort required to finalize and close the TMF for new applications or study completion. * **Configurable Review Rules:** The review rules and checks within the system are configurable, allowing organizations to tailor the quality review process to their specific needs and pertinent regulatory agencies. Tools/Resources Mentioned: * PhlexTMF: Phlexglobal's eTMF software solution. * Review Templates: Automated configurations for document sampling and review parameters. * Review Packages: System-generated containers for organizing and assigning TMF review tasks. * Event Raising Functionality: A feature within PhlexTMF to log and manage discrepancies or missing information. Key Concepts: * **Trial Master File (TMF):** A collection of essential documents that individually and collectively permit the evaluation of the conduct of a clinical trial and the quality of the data produced. * **TMF Quality Review (QR):** The systematic process of checking TMF documents for completeness, accuracy, and compliance with regulatory requirements and internal SOPs. * **ICH E6 (R2):** The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) E6 (R2), which provides a unified standard for clinical trial conduct. * **Form 1572 (Statement of Investigator):** A form used in clinical trials in the United States to provide information about the investigator and site, committing to comply with FDA regulations. * **SOPs (Standard Operating Procedures):** Detailed, written instructions to achieve uniformity of the performance of a specific function. * **Risk-Based Approach:** A strategy that prioritizes activities based on their potential impact on data integrity, patient safety, and regulatory compliance. Examples/Case Studies: * **Reviewing a Form 1572:** The demonstration specifically shows a reviewer checking a Form 1572 for completeness, correct filing, and accurate listing of IRB information. * **Cross-checking Investigator Lists:** An example is provided where the system cross-checks investigators listed on the 1572 form against those recorded in the system. When a discrepancy is found (e.g., Dr. Paul Newton is listed on the form but not in the system), an "event" is raised. * **Automated Document Collection:** Raising an "event" for a missing investigator automatically triggers the collection of all required documents for that individual, demonstrating how the system streamlines the remediation process.
AstraZeneca: Clinical Transformation Journey Overview
Veeva Systems Inc
/@VeevaSystems
Feb 22, 2021
This video provides an in-depth exploration of AstraZeneca's multi-year clinical transformation journey, focusing on enhancing trial efficiency, speed, and quality through digital innovation. Debbie, representing AstraZeneca, outlines the strategic imperatives that drove this initiative, which began approximately three years prior, aiming to fundamentally reimagine their ways of working for clinical trials. The core objective was to simplify and streamline processes, redefine clinical trials through digital health, and ultimately improve patient outcomes and experiences, aligning with their "Patients First" value. A central theme of AstraZeneca's transformation was the simplification of their complex system landscape, which they metaphorically described as moving from a "spaghetti of systems" to a more organized "lasagna" architecture. Initially, they grappled with disparate, poorly integrated systems that necessitated duplicate data entry, leading to inconsistencies and delays in information transfer. Their future vision involved a unified, streamlined architecture with a central data hub or platform, fed by foundational source systems like Veeva Clinical Vault. This approach aims to establish a single source of truth, eliminating redundant data entry and enabling the application of advanced and predictive analytics for data-driven design, predictive decision-making, and patient-facing tools. The transformation project yielded several key solutions designed to optimize various aspects of clinical development. These included "Merlin," a digital and analytics solution focused on study design, leveraging data to inform scientific and operational design, reduce study costs, and facilitate faster, data-driven site selection by integrating electronic health records. Another critical component was the "Control Tower," a visualization tool that pulls data from the central platform to apply advanced and predictive analytics for real-time study performance monitoring. This system helps identify potential risks early, enabling timely course correction and significantly reducing reliance on manual spreadsheet tracking, with an estimated automation of 400,000 hours of manual reporting. Additionally, efforts were made to optimize clinical supply forecasting, aiming to reduce design waste from 50% to 20%, eliminate 5,000 shipments, and save approximately $120 million, while also advancing sustainability objectives. Finally, a cornerstone of this transformation was the adoption of a unified clinical system, with Veeva Clinical Vault serving as a foundational platform. This represented AstraZeneca's most significant clinical system change in two decades. The goal was to create a single entry point for data, managing and executing clinical trials from start to closeout on one platform. By leveraging their existing Veeva eTMF capabilities and integrating new modules like CTMS and Study Startup, AstraZeneca achieved a seamless user experience across different functionalities. This unified approach enhances transparency for global and local study teams, streamlines operations through automation, and significantly improves inspection readiness by combining document management (TMF) with milestone tracking and study startup functionality. Key Takeaways: * **Strategic System Simplification:** AstraZeneca successfully embarked on a journey to untangle a complex "spaghetti of systems" into a more unified "lasagna" architecture, highlighting the critical need for system landscape simplification in large pharmaceutical organizations to improve efficiency and data integrity. * **Centralized Data Platform:** The establishment of a central data hub or platform is paramount for achieving a single source of truth, eliminating duplicate data entry, and ensuring consistency across various clinical systems. This foundational element enables advanced analytics and data-driven decision-making. * **Leveraging Advanced and Predictive Analytics:** The transformation emphasizes the power of advanced and predictive analytics for data-driven study design (e.g., Merlin), real-time performance monitoring (e.g., Control Tower), and predictive decision-making, moving beyond reactive management to proactive intervention. * **Significant Automation Potential:** The "Control Tower" solution alone is projected to automate approximately 400,000 hours of manual reporting previously performed by study teams, underscoring the immense efficiency gains achievable through digital transformation and automation in clinical operations. * **Integrated Veeva Ecosystem:** AstraZeneca strategically leveraged its existing investment in Veeva eTMF by integrating additional Veeva Clinical Vault modules (CTMS, Study Startup) to create a unified clinical platform. This demonstrates the value of building upon existing enterprise solutions to expand capabilities. * **Seamless User Experience:** A key design principle was to ensure end-users perceive a single, seamless interface when navigating between different modules within the Veeva Clinical Vault suite, enhancing user adoption and reducing operational friction. * **Improved Inspection Readiness:** By unifying document management (eTMF) with study milestones and startup functionalities on a single platform, AstraZeneca significantly improved data transparency and quality, directly contributing to better inspection readiness and regulatory compliance. * **Data-Driven Study Design and Site Selection:** The "Merlin" solution showcases how digital tools and analytics can drive more informed study design, reduce time and costs, and enable faster, data-driven site selection by integrating diverse data sources, including electronic health records. * **Optimized Clinical Supply Chain:** The project addressed clinical supply chain inefficiencies, aiming to reduce design waste from 50% to 20% and eliminate 5,000 shipments, leading to substantial cost savings ($120 million) and contributing to organizational sustainability goals. * **Shift from Static to Real-time Data:** The move away from manual tracking in static spreadsheets to real-time, live data within integrated systems provides up-to-date views of study status, enabling more agile risk mitigation and course correction. * **Patient-Centric Digital Solutions:** All transformation efforts are underpinned by the overarching goal of improving outcomes and experiences for patients, with the development of patient-facing tools as a direct outcome of the data platform and analytics capabilities. * **Long-term Organizational Change:** The initiative represents a significant organizational change for AstraZeneca, described as the biggest clinical system change in 20 years, highlighting the scale and commitment required for such a comprehensive digital transformation. Tools/Resources Mentioned: * Veeva Clinical Vault * Veeva eTMF (Electronic Trial Master File) * Veeva CTMS (Clinical Trial Management System) * Veeva Study Startup * Merlin (AstraZeneca's internal solution for study design) * Control Tower (AstraZeneca's internal visualization tool for performance monitoring) Key Concepts: * **Spaghetti of Systems:** A metaphor used to describe a highly complex, poorly integrated, and disparate collection of IT systems within an organization. * **Lasagna Architecture:** A metaphor for a more unified, streamlined, and layered IT architecture, implying better organization and integration compared to a "spaghetti of systems." * **Data Hub/Data Platform:** A centralized repository and processing system for data from various source systems, designed to create a single, consistent view of information. * **Single Source of Truth:** A concept in data management where all data elements are stored exactly once, preventing inconsistencies and ensuring data integrity across an organization. * **Data-Driven Design:** An approach to designing clinical studies and operations based on insights derived from data analysis rather than assumptions or traditional methods. * **Predictive Analytics:** The use of data, statistical algorithms, and machine learning techniques to identify the likelihood of future outcomes based on historical data. * **Inspection Readiness:** The state of being prepared to demonstrate compliance with regulatory requirements during an audit or inspection, often facilitated by organized and accessible data and documentation. Examples/Case Studies: * **AstraZeneca's 3-Year Clinical Transformation:** The entire video serves as a case study of AstraZeneca's journey to modernize its clinical operations. * **Automation of 400,000 Hours:** A specific example of efficiency gain, demonstrating the potential for automating manual reporting tasks through the "Control Tower" system. * **$120 Million Savings in Supply Chain:** A concrete financial benefit achieved through optimizing clinical supply forecasting and reducing design waste.
Medical Tech Giant - Veeva Systems (VEEV) - NYSE Growth Stocks
Aussie Investing Machine
/@aussieinvestingmachine9912
Feb 19, 2021
This video provides an in-depth analysis of Veeva Systems (VEEV), a prominent cloud computing company specializing in pharmaceutical and life sciences industry applications. The speaker details Veeva's strategic aim to digitalize the entire industry by connecting pharmaceutical companies to doctors and patients. Key areas of Veeva's innovation highlighted include their clinical vision, which focuses on streamlining historically paper-based clinical trials through their Vault platform for data management, operations, regulatory approvals, and drug safety. The video also discusses Veeva's "My Veeva" software for patient engagement (virtual consent, visits, adherence) and their solutions for healthcare professionals to manage complex interactions with multiple pharmaceutical companies, ensuring access to up-to-date product and safety information. The overall narrative emphasizes Veeva's market dominance, consistent financial growth, and ongoing expansion into a "white space market" within the life sciences sector. Key Takeaways: * **Centrality of Veeva in Life Sciences Digitalization:** The video reinforces Veeva Systems' critical role as a leading platform for digital transformation within the pharmaceutical and life sciences industries * **Opportunities in Clinical Trial Digitalization:** Veeva's significant investment in digitalizing clinical trials, from data capture and operations to regulatory submissions (e.g.ai to apply its AI, data engineering, and regulatory compliance expertise to further optimize these processes. * **Data Engineering as a Foundational Need:** The video consistently underscores the importance of data capture, verification, cleaning, and formatting across Veeva's platforms. * **Integrated Regulatory Compliance:** Veeva's built-in capabilities for regulatory processes (e.g.
Vault eTMF Demo: Part 4 – TMF Viewer
Veeva Systems Inc
/@VeevaSystems
Feb 11, 2021
This video provides an in-depth exploration of the Veeva Vault eTMF Viewer, a critical feature designed to streamline the management and navigation of Trial Master File (TMF) content within the Veeva Vault platform. The presenter begins by establishing the viewer's main purpose: enabling users to efficiently browse dynamically organized TMF content and switch between multiple configured hierarchies. This functionality is highlighted as particularly beneficial for supporting regulatory inspections, accommodating various inspector preferences for navigation, and significantly reducing the administrative burden traditionally associated with manual binder creation and maintenance. The core message is that Vault eTMF automates much of this work, allowing users to focus on content rather than organization. The demonstration proceeds with a practical tour of the eTMF Viewer interface. Upon navigating to the TMF viewer tab, users are presented with a study, country, and site selector, a feature familiar from the TMF homepage launched in 19r1, which allows for granular drill-down into specific trial contexts. As selections are made (e.g., Finland and Site 5280), the folder structures on the left-hand side dynamically update to display only sections containing relevant content, a design choice directly influenced by customer feedback to avoid confusion from empty sections. The viewer also supports various TMF reference models, including versions 3.0, 2.0, and Veeva's proprietary "Vault Clinical Docs" hierarchy, offering flexibility in how documents are structured and viewed. Further capabilities showcased include an "expand all" button for comprehensive viewing of all subsections and the ability to filter down to the contents of a single section. A key highlight is the robust search and filtering functionality. For instance, a study manager needing to identify expired investigator CVs can simply search for "CV" and then filter the expiration date column to pinpoint documents expiring before a specific date, a feature explicitly noted as valuable for inspections. The video also illustrates how to view different versions of informed consent forms (ICFs) by expanding search results. Crucially, the eTMF Viewer respects security and permissions, ensuring users only access documents they are authorized to see. The demonstration concludes by showing how users can perform direct actions on documents from within the viewer, such as logging quality issues or uploading new versions, and how to export lists of documents with hyperlinks that lead directly back to the content in Vault, further enhancing efficiency and accessibility. Key Takeaways: * **Centralized TMF Management:** The Veeva Vault eTMF Viewer provides a unified interface for managing and accessing all Trial Master File content, eliminating the need for disparate systems or manual binders. * **Dynamic Content Organization:** The viewer dynamically organizes TMF content and allows users to switch between multiple configured hierarchies, such as the TMF Reference Model 3.0, 2.0, or Veeva's Vault Clinical Docs, offering flexibility in content presentation. * **Enhanced Inspection Readiness:** The system is designed to support regulatory inspections by providing easy search, filter, and navigation capabilities, allowing inspectors to self-navigate or be guided through the TMF efficiently. * **Reduced Administrative Burden:** By automating the organization and maintenance of TMF content, the eTMF Viewer significantly reduces the manual effort associated with binder creation and upkeep, freeing up valuable resources. * **Granular Navigation:** Users can drill down to specific study, country, and site levels using a dedicated selector, ensuring focused access to relevant TMF documents for particular trial contexts. * **Intelligent Content Display:** Based on customer feedback, the system intelligently displays only those TMF sections that contain actual content when specific study, country, or site filters are applied, preventing confusion from empty folders. * **Powerful Search and Filtering:** The viewer offers robust search capabilities (e.g., searching for "CV" or "consent") combined with column filtering (e.g., filtering by expiration date) to quickly locate specific documents or identify items needing attention, such as expired investigator CVs. * **Version Control and Document Actions:** Users can easily view different versions of documents, such as informed consent forms, and perform direct actions on documents from within the viewer, including logging quality issues or uploading new versions. * **Security and Permissions Enforcement:** The eTMF Viewer strictly adheres to configured security settings and user permissions, ensuring that individuals can only access documents they are authorized to view, maintaining data integrity and compliance. * **Export Functionality with Direct Links:** The ability to export lists of documents to Excel, with embedded hyperlinks that lead directly back to the respective documents in Vault, facilitates offline review and sharing while maintaining traceability. Tools/Resources Mentioned: * Veeva Vault eTMF * TMF Reference Model 3.0 * TMF Reference Model 2.0 * Veeva's hierarchy: Vault Clinical Docs * Microsoft Excel (for document list export) Key Concepts: * **TMF Viewer:** A specific feature within Veeva Vault eTMF designed for browsing, searching, filtering, and managing Trial Master File content. * **eTMF (Electronic Trial Master File):** A digital system for managing essential documents of a clinical trial, crucial for demonstrating compliance with regulatory requirements. * **TMF Reference Model:** An industry-standard, hierarchical model for organizing and categorizing TMF documents, ensuring consistency and completeness across clinical trials. * **Inspections:** Regulatory audits conducted by authorities (e.g., FDA, EMA) to verify the conduct of clinical trials and the integrity of their documentation, for which an organized eTMF is critical. * **CV (Curriculum Vitae):** A document detailing an investigator's professional and academic history, often required to be current for regulatory compliance in clinical trials. * **ICF (Informed Consent Form):** A document signed by a participant in a clinical trial, indicating their voluntary agreement to participate after being fully informed about the study's nature, risks, and benefits.
Navigating Constant Change With Flexible Quality Systems
MasterControl
/@MasterControlVideo
Feb 3, 2021
This video provides an in-depth exploration of navigating constant change within the life sciences industry through the adoption of flexible, digital quality systems. Presented by MasterControl's senior product managers, Aaron Wright and Kim Jackson, the webinar begins by establishing the post-COVID "new normal" where constant change and unforeseen external forces necessitate resilience and agility. The core argument is that moving from paper-based or siloed digital systems to a connected, cloud-first Quality Management System (QMS) is no longer a "nice-to-have" but a critical "must" for survival and growth in regulated environments. The presentation progresses by detailing how digitalization resolves common quality pains, such as communication breakdowns and disruptions, by providing structured, accessible data. It then emphasizes how a connected platform enhances organizational agility and resilience, citing examples like adapting to remote regulatory inspections and managing supply chain disruptions during the pandemic. A significant portion of the discussion focuses on the power of holistic, data-driven decision-making, moving beyond gut feelings to leverage integrated quality and risk data. The speakers introduce the concept of a "culture of quality," where quality is seen as everyone's responsibility, not just a department's, and how connected data and metrics can foster this culture, driving continuous improvement and business thriving. Key themes include the critical role of risk management as a living, breathing process, not merely a paperwork exercise, and the limitations of unstructured data in identifying crucial patterns. The video highlights the transformative potential of machine learning (ML) and artificial intelligence (AI) in sifting through vast amounts of data to find patterns, predict potential issues (like recalls or equipment failures), and guide root cause analysis. While AI can perform the "heavy lifting" of pattern recognition, the human element remains vital for contextualizing insights and making final decisions. The discussion also touches on the financial implications, framing digital transformation as a strategic investment that reduces the "cost of poor quality" and accelerates revenue generation. Key Takeaways: * **Digitalization is Essential for Quality:** The shift from paper-based or unstructured digital documents (e.g., shared Excel files) to a structured, cloud-based QMS is imperative. This move resolves common quality pains by improving communication, collaboration, minimizing disruptions, and maximizing the quality of work, especially in a remote or constantly changing environment. * **Connected Platforms Drive Agility and Resilience:** A unified, connected QMS platform allows companies to respond rapidly to unforeseen changes, such as global pandemics or regulatory shifts. It streamlines processes like regulatory inspections (now often virtual) and enables quick root cause analysis for deviations, making the organization more adaptable and resilient. * **Holistic Data-Driven Decision Making:** Relying on gut feelings is no longer sufficient. A connected platform provides access to integrated data from all parts of the organization—manufacturing, quality control, operations, supply chain—enabling context-based, data-driven decisions that impact strategic direction and daily operations. * **Risk Management as a Living Process:** Risk assessment and mitigation should be an ongoing, analytical tool, not a one-and-done paperwork exercise. Standards like ISO 14971 and EU MDR emphasize continuous analysis of risk, including post-market surveillance, and the critical thinking behind risk plans, rather than just documentation. * **Unstructured Data is a Barrier to Insight:** Critical information and research connections are often trapped in unstructured documents, preventing effective pattern recognition and data-driven insights. This hinders the ability to connect process changes to product impacts or identify systemic hazards. * **Machine Learning and AI for Pattern Recognition:** AI and ML are crucial for sifting through large volumes of data to identify patterns that humans might miss. These technologies can provide predictive analytics for post-market complaints, likely root causes, and potential equipment failures, guiding proactive interventions. * **Humans Provide Context for AI Insights:** While AI excels at finding correlations and patterns, it cannot perform root cause analysis or attribute meaning to data. Human expertise is essential to contextualize AI-generated insights, make informed decisions, and develop actionable strategies. * **Quality is Everyone's Responsibility:** A true "culture of quality" means that every employee, from the manufacturing line to the C-suite, understands and contributes to meeting quality standards. Empowering frontline personnel to report events directly, without intermediaries, fosters ownership and improves data accuracy. * **Digital Transformation is a Strategic Investment:** The upfront cost of implementing a digital QMS and AI solutions is an investment that yields significant returns. It reduces the "cost of poor quality" (e.g., scrap, recalls, regulatory fines, PR damage) by enabling prevention over cure, improving efficiency, and accelerating time to market. * **Global Data Connectivity Prevents Redundancy:** For multi-site, multi-product organizations, a single, connected data lake prevents individual sites from repeating root cause analyses or making decisions in silos. It allows for the surfacing of global trends and commonalities, driving consistent improvements across the enterprise. * **Continuous Improvement Through Risk Mitigation:** By continuously feeding risk mitigations and their implementation into the QMS, organizations can measure the effectiveness of these actions and drive ongoing improvement. This moves beyond the "As Low As Reasonably Practical" (ALARP) mindset to a constant pursuit of enhanced safety and quality. **Key Concepts:** * **Cloud-first mindset:** Prioritizing cloud-based solutions for all systems, especially quality management, to ensure accessibility, scalability, and collaboration. * **Next normal:** The evolving state of business operations and quality management practices in response to ongoing global changes and disruptions. * **Holistic data-driven decision making:** Integrating data from all organizational functions (e.g., manufacturing, quality, supply chain) to make comprehensive and informed business decisions, moving beyond isolated departmental insights or gut feelings. * **Culture of quality:** An organizational environment where quality is embedded in every job role and responsibility, rather than being solely the domain of a specific quality department. * **Signal-to-noise ratio:** The challenge of identifying meaningful data patterns and insights amidst a large volume of irrelevant or less critical information, particularly in post-market surveillance. * **Cost of Quality:** A business metric that quantifies the expenses associated with preventing, detecting, and remediating quality issues, emphasizing the long-term savings from upfront investments in quality systems. **Examples/Case Studies:** * **COVID-19 Pandemic:** Used as the primary example of a "year like no other" that accelerated the need for digital transformation, remote operations (e.g., virtual regulatory inspections), and resilient supply chains in the life sciences industry. * **Machinist Calibration Failures:** An example of how machine learning could identify patterns where a specific machinist performing equipment calibration across multiple sites consistently leads to equipment failures months later. * **Post-Market Complaint Trends:** Illustrates how connected data can provide deeper insights into post-market complaints, identifying specific products manufactured at particular locations or lines that are experiencing issues, thereby guiding immediate root cause analysis. * **Process Validation & Predictive Maintenance:** Discusses moving from fixed engineering assessments (e.g., a hood failing at 60 days) to real-time predictive analytics that might show consistent failure at 47 days, allowing for proactive maintenance and risk mitigation.
TQA Cloud QMS Bootcamp | Implementing a Quality Management System | Session 3 | #QualityMatters
Texas Quality Assurance | #QualityMatters Podcast
/@texasqa
Feb 1, 2021
This video provides an in-depth exploration of implementing a Quality Management System (QMS), focusing specifically on process mapping and an integrative process approach. Kyle Chambers, CEO and founder of Texas Quality Assurance, presents this session as part of a condensed, free online QMS bootcamp, originally a four-day course. The core purpose is to equip leadership and quality management teams with the skills to develop, implement, and maintain an effective QMS, emphasizing the critical role of quality management and assurance programs for business success, particularly for small businesses. The session delves deeply into the "process approach," highlighting its importance as a systematic way to view the interconnected pieces of a management system, moving beyond superficial document control to understand how various elements interact. A central framework discussed is the Plan-Do-Check-Act (PDCA) cycle, presented as a fundamental and iterative model essential at every step of process mapping. Chambers stresses that the cycle begins with a clear "quality policy" (broadly defined to include health, safety, or environmental policies), which must align with the organization's values and mission, serving as more than just lip service for compliance. He also notes that Edward Deming's original model used "Study" instead of "Check," underscoring the depth of analysis required. The discussion progresses to the practical application of the PDCA cycle, detailing each phase: Plan (defining desired outcomes, goals, metrics, KPIs), Do (performing the work, utilizing work instructions), Check (pre-defined measures against planning requirements, inspections), and Act (taking actions like accepting, reworking, or scrapping, leading to continuous improvement or corrective/preventative actions). Chambers critiques the standard ISO 9001 diagram for its complexity, advocating for a more intuitive "integrative process approach" model. This model emphasizes identifying resources/inputs, goals/objectives, expected outputs, and checks/measures, with the "process" and "controls" fitting in the middle. He introduces "integrative thinking" as the ability to constructively resolve tensions between opposing models by creating a new, superior solution that incorporates elements of both, which is core to the process approach's method-agnostic nature. Key Takeaways: * **QMS Bootcamp Value:** The QMS Bootcamp is a valuable, condensed online course designed to teach leadership and quality management teams how to develop, implement, and maintain a QMS, offered freely to support businesses. * **The Process Approach is Fundamental:** A systematic view of interconnected processes is crucial for understanding how a management system truly functions, moving beyond simple document control. * **PDCA Cycle is Iterative:** The Plan-Do-Check-Act (PDCA) cycle is not a one-time concept but an integral, iterative framework that must be applied at every stage of process mapping and QMS management. * **Quality Policy Alignment:** A "quality policy" (which can encompass health, safety, or environmental aspects) must be in strong alignment with the organization's values and mission to drive long-term success, not just for compliance. * **"Study" Emphasizes Depth:** Edward Deming's original "Plan-Do-Study-Act" cycle highlights the importance of deeply studying processes rather than merely checking them, advocating for thorough analysis. * **Focus on Added Value:** Every process step should be continually questioned for its added value to the organization; steps that cannot justify their existence are potential waste to be eliminated. * **Factual-Based Decision Making:** Improvement of processes must be based on data and information, aligning with the quality management principle of evidence-based decision making, rather than subjective opinions. * **Define Desired Outcomes First:** The single most critical part of the planning process is defining desired outcomes, purpose, and scope; without these, efforts are likely wasted. * **Distinguish Process Procedures from Work Instructions:** Understand the difference between a specific, single-function work instruction (e.g., lockout/tagout) and a broader process procedure that considers interconnected processes and their wider impact. * **Pre-defined Checks are Essential:** The "Check" phase of PDCA should involve pre-defined measures, acceptance criteria, and customer requirements to ensure consistency and effectiveness in evaluating work. * **The "Act" Phase Drives Improvement:** The "Act" phase is where decisions are made (accept, rework, scrap), generating valuable data for corrective and preventative actions, feeding into continuous improvement. * **Integrative Thinking Resolves Conflict:** Applying "integrative thinking" helps resolve disagreements by focusing on problem requirements and combining elements from opposing solutions to create a superior, new model. * **Practical Process Mapping Model:** A more effective process map identifies resources/inputs, goals/objectives, expected outputs, and checks/measures, allowing the "process" and "controls" to be flexibly defined in between. * **Process Maps as Internal Tools:** Process maps should be treated as evergreen, internal guides for managers and owners, not controlled documents, to avoid unnecessary complexity in audit processes and encourage continuous editing and improvement. * **Process Maps for Conflict Resolution:** Utilizing a process map to define requirements, limits, vision of good, and checks can effectively reduce tensions and solve problems when teams or managers have differing opinions. **Tools/Resources Mentioned:** * **TQA Cloud:** Texas Quality Assurance's flagship QMS software product. * **Texas Quality Assurance Website:** Offers free samples of process procedures. * **Harvard Business Review on Audible:** Recommended for learning about integrative thinking. * **OSHA CFRs (Code of Federal Regulations):** Specifically mentioned CFR 1910 for general industry, as a critical input for health and safety management systems. * **ISO 9001:** The international standard for Quality Management Systems, referenced for its principles and diagrams. **Key Concepts:** * **Quality Management System (QMS):** A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. * **Process Mapping:** The visual representation of the steps and decisions involved in a process, used to understand, analyze, and improve workflows. * **Process Approach:** A management strategy that views an organization as a system of interconnected processes, focusing on how these processes interact to achieve desired outcomes. * **PDCA Cycle (Plan-Do-Check-Act/Study):** An iterative four-step management method used for the control and continuous improvement of processes and products. * **Integrative Thinking:** The ability to constructively consider opposing ideas simultaneously to generate a new, superior solution that incorporates elements of both. * **Integrative Process Approach:** A methodology that combines integrative thinking with the process approach to build effective QMS by considering numerous variables (interested parties, customers, employees, competitors, capabilities, costs, industry trends, regulatory environment) into a cohesive solution. * **Quality Policy:** A formal statement by management, closely linked to the business plan and marketing approach, which defines the overall intentions and direction of an organization with regard to quality. * **Fact-based Decision Making:** A quality management principle emphasizing that effective decisions are based on the analysis of data and information. * **Work Instruction vs. Process Procedure:** A work instruction is a detailed, step-by-step guide for a specific task, often for one location or function. A process procedure describes a broader process, considering its interconnectedness and impact on other organizational functions. **Examples/Case Studies:** * **Coffee Pot Process Mapping:** A lighthearted example mentioned from another video, used to illustrate the absurdity and simplicity of initial process mapping exercises. * **Powered Industrial Trucks (Forklift) Program:** A detailed, real-world example used to demonstrate the integrative process approach. This included: * **Resources/Inputs:** OSHA CFR 1910, current operating environment (ramps, docks, trailer types), and employee experience levels. * **Goals/Objectives:** Zero accidents, zero injuries, saving time and effort, and ensuring proper maintenance to reduce costs. * **Outputs:** Zero incidents, improved efficiency, reduced costs. * **Checks/Measures:** Annual internal audits, comprehensive training programs (classroom, quiz, practical driving exam), and daily pre-operational maintenance inspections using laminated checklists on forklifts. * **Process/Controls:** Establishing a forklift in each shop, preventative maintenance schedules, and training schedules, with specific procedures for the PIT program and training.
NNIT Webinar: IDMP enforcement in Europe in 2021
NNIT | We make a mark
/@NNITvideo
Jan 25, 2021
This video provides a critical update on the European Medicines Agency's (EMA) Identification of Medicinal Products (IDMP) initiative, focusing on its enforcement timelines and the latest developments in the implementation guide. The speakers, regulatory affairs experts from NNIT, detail the expected publication of IDMP Implementation Guide Version 2 on February 22, 2021, which sets the mandatory go-live date for PMS (Product Management System) Iteration 1 fields for the industry by February 22, 2023. The discussion highlights the significant impact on regulatory affairs, the need for comprehensive data management and quality, and the ongoing evolution of EMA's approach to IDMP, including an agile documentation strategy and updates on substance data management. Key Takeaways: * **Imminent IDMP Enforcement:** The EMA has set a concrete timeline for IDMP enforcement, with PMS Iteration 1 becoming mandatory for industry by February 22, 2023, following the publication of Implementation Guide Version 2. This signals a definitive move towards compliance after years of delays. * **"One Side IDMP, Always IDMP" Mandate:** An unofficially confirmed but critical rule states that once a company submits IDMP information for one product, all other products in its portfolio must subsequently follow suit. This eliminates the possibility of small-scale pilots and necessitates a comprehensive, portfolio-wide IDMP strategy from the outset. * **Holistic Data & Process Transformation:** IDMP compliance extends beyond IT systems, requiring significant organizational effort in locating and ensuring the quality of required data, as well as fundamental changes to business processes across regulatory, commercial, and potentially clinical operations. * **Evolving Substance Data Management:** The EMA is actively cleansing and synchronizing substance data through its EU SRS and SMS projects, with a focus on aligning with the FDA's GSRS. This indicates a push towards greater international harmonization in substance identification and management. * **Limitations of Standard RIM Systems:** While many Regulatory Information Management (RIM) system providers are incorporating IDMP roadmaps, their solutions primarily address data model expansion and basic functionality. They often do not cover critical aspects like comprehensive data quality monitoring, integration with other enterprise systems, or the necessary adjustments to overall submission processes, highlighting the need for broader data engineering and process re-design efforts. * **Strategic Industry Preparation is Crucial:** Companies must proactively prepare by staying updated on regulatory changes, mapping substances and referentials, and raising internal awareness. It's essential to plan for all product types (centralized, mutual recognition, decentralized, and national procedures) from the beginning, rather than focusing solely on centralized products.
Veeva Systems CEO on powering Covid-19 treatments, pharma partnerships
CNBC Television
/@CNBCtelevision
Jan 14, 2021
This video features Peter Gassner, CEO and founder of Veeva Systems, discussing his company's pivotal role in supporting the life sciences industry, particularly in the context of the COVID-19 pandemic. The interview, conducted by CNBC's "Squawk on the Street" team, delves into how Veeva's technology bridges operational gaps and enhances efficiency for pharmaceutical companies, from drug development to manufacturing and distribution. Gassner provides a comprehensive overview of Veeva's contributions to accelerating the delivery of critical treatments and vaccines, highlighting the industry's rapid response and the underlying technological infrastructure. Gassner elaborates on the specific ways Veeva's technology empowers life sciences companies. He explains that Veeva provides solutions for designing and operating clinical trials, collecting and analyzing patient data, and monitoring manufacturing controls. This includes ensuring that production processes are compliant and safe, which is paramount in the highly regulated pharmaceutical sector. The CEO emphasizes that their technology is instrumental in helping companies become more efficient and effective, ultimately speeding up the process of bringing essential medicines and therapeutics to market. The discussion frequently circles back to the unprecedented speed at which the life sciences industry developed COVID-19 vaccines, attributing part of this success to cloud technology and the dedication of their customers. A significant portion of the conversation is dedicated to the broader impact of Veeva's work on productivity, efficiency, and cost reduction within the pharmaceutical industry. Gassner underscores that cloud technology enables companies to streamline operations, reduce costs, and accelerate timelines, which was particularly critical during the pandemic. He expresses immense pride in the life sciences industry's performance, giving it an "A" grade for its rapid innovation and deployment of vaccines, noting that such speed was previously unimaginable. He also points out that long-term investments in technologies like RNA, made years ago, are now paying off dramatically. The interview concludes with a discussion of Veeva's recent conversion to a Public Benefit Corporation (PBC), a move that legally obligates the company to consider the interests of its customers, employees, and society alongside shareholders, signaling a shift towards a more inclusive form of capitalism. Key Takeaways: * Veeva Systems' core mission is to serve the life sciences industry by providing technology that significantly enhances efficiency and effectiveness in the development and distribution of medicines and therapeutics. * The company's technology supports critical stages of drug development, including the design and operation of clinical trials, the collection and analysis of patient data, and the rigorous monitoring of manufacturing controls. * A key focus of Veeva's solutions is ensuring regulatory compliance and safety throughout the entire manufacturing process, which is vital for pharmaceutical and biotech companies. * Cloud technology is highlighted as a fundamental enabler for achieving greater efficiency and speed, particularly in accelerating the development and market entry of new treatments like COVID-19 vaccines. * The life sciences industry demonstrated an unprecedented level of speed and productivity during the pandemic, a success partially attributed to the availability of advanced technology and significant prior investments in areas such as RNA technology. * Veeva Systems recently made history by becoming the first public company to convert to a Public Benefit Corporation (PBC), following an overwhelming shareholder vote of over 99% in favor. * This PBC conversion legally expands Veeva's corporate responsibility beyond just financial returns for shareholders to include a broader commitment to customers, employees, and society in general. * The move to a PBC signifies a strategic shift towards a new model of capitalism that integrates social and environmental considerations alongside traditional financial objectives, aligning with the growing trend of ESG investing. * The CEO expresses strong confidence and pride in the life sciences industry's ability to innovate rapidly and deliver critical solutions under immense pressure, despite the inherent challenges in vaccine distribution. * The discussion underscores the ongoing and accelerating digitization of the pharmaceutical sector, where technology plays an increasingly crucial role in bridging operational gaps, optimizing processes, and improving overall outcomes. Key Concepts: * **Public Benefit Corporation (PBC):** A type of for-profit corporate entity, authorized in many U.S. states, that includes positive impact on society and the environment in addition to profit as its legally defined goals. * **ESG Investing:** Environmental, Social, and Governance investing, a framework used to evaluate corporate performance and ethical impact beyond traditional financial metrics. * **Digitization of Life Sciences:** The ongoing transformation of pharmaceutical and biotech operations through the adoption of digital technologies to improve efficiency, data management, and regulatory compliance. * **Clinical Trials:** Research studies conducted on human volunteers to evaluate the safety and efficacy of new drugs, medical devices, or treatments. * **Manufacturing Controls:** Systems and procedures implemented in pharmaceutical manufacturing to ensure product quality, consistency, and compliance with regulatory standards. Examples/Case Studies: * **COVID-19 Vaccine and Treatment Development:** The video frequently references the rapid development and distribution of COVID-19 vaccines and treatments as a prime example of the life sciences industry's efficiency and the role of technology. * **RNA Technology Investment:** Peter Gassner specifically mentions the significant investments made in RNA technology six to ten years prior, which proved crucial in enabling the rapid development of mRNA-based COVID-19 vaccines.
2021-01-11 TMF Reference Model General Meeting
TMF Reference Model
/@TMFReferenceModel
Jan 12, 2021
This video provides an in-depth exploration of the TMF Reference Model, detailing its history, current status, and future initiatives as presented during its first general meeting of 2021. The session, led by Karen Roy, co-chair of the reference model and chair of the steering committee, aimed to refresh attendees on the model's purpose and evolution, while also soliciting community feedback on potential improvements and new directions. Key discussions revolved around standardizing Trial Master File (TMF) content, structure, naming conventions, and metadata to enhance collaboration, streamline regulatory inspections, and improve overall operational efficiency within clinical trials. The presentation delved into the foundational aspects of the TMF Reference Model, which originated in 2009 from a DIA EDM reference model initiative to standardize TMF structures across the industry. It highlighted the significant growth of the model, now managed by a formal Charter, a 14-member Steering Committee, and a Change Control Board responsible for version control and incorporating community feedback. The benefits of adopting a standardized TMF structure were emphasized, particularly for sponsors and Contract Research Organizations (CROs) working together, as well as for regulatory inspectors who are increasingly familiar with the model. The discussion also touched upon the practicalities of implementing the model, including strategies for transitioning from company-specific structures and the role of vendors in supporting different versions. A significant portion of the meeting was dedicated to reviewing existing deliverables and proposing areas for refresh and new initiatives. Current deliverables include guidance on email communication, a real-world study document index, and a TMF plan template. Three key documents identified for potential revision were TMF Quality Control, Inspection Readiness (including RACI and FAQs), and TMF Metrics, with a strong emphasis on updating them to reflect advancements like ICH GCP R2/R3, the rise of virtual inspections, and the integration of artificial intelligence into TMF systems. The active initiative on the TMF Exchange Mechanism was also presented, outlining its role as a technical standard using APIs, the TMF Reference Model coding, and XML to facilitate efficient, quality-preserving transfer of TMF information between collaborators. Future initiatives, driven by community surveys, included developing a formal training course, expanding coverage to all study types, bridging clinical and regulatory documentation, and establishing a definitive set of minimal metadata per artifact. Key Takeaways: * **Standardization is Crucial for TMF Management:** The TMF Reference Model's primary purpose is to standardize TMF content, structure, naming, and minimal metadata, which is essential for consistent documentation across the pharmaceutical and life sciences industries. * **Enhanced Collaboration and Regulatory Compliance:** Adopting the TMF Reference Model significantly improves collaboration between sponsors and CROs by providing a common framework. It also aids regulatory inspections, as inspectors are increasingly familiar with the standardized structure, reducing queries and streamlining audits. * **Structured Governance and Continuous Improvement:** The TMF Reference Model is managed by a formal Charter, a diverse Steering Committee, and a Change Control Board, ensuring its ongoing relevance, controlled version releases (maintenance, minor, major), and responsiveness to industry feedback. * **Strategic Implementation of TMF Model Updates:** Organizations should take a risk-based approach when updating their TMF systems from one minor version to another (e.g., 3.1 to 3.2), considering the relevance of changes to their operations. Major releases (e.g., to 4.0) may warrant a more comprehensive re-evaluation. * **Vendor Support for TMF Versions:** The industry sees a mixed approach from vendors regarding support for multiple TMF Reference Model versions, with some systems accommodating different versions for different studies, while others facilitate migration. * **Key Deliverables and Their Refresh Needs:** Existing deliverables like Email Communication Guidance, Real World Study Document Index, and TMF Plan Template are valuable. However, documents on TMF Quality Control, Inspection Readiness, and TMF Metrics require updates to incorporate ICH GCP R2/R3, new technologies, virtual inspection protocols, and the impact of AI. * **The TMF Exchange Mechanism for Data Integrity:** This technical standard facilitates the efficient and quality-preserving transfer of TMF information between collaborators (sponsors, CROs, sites, labs). It leverages APIs, the TMF Reference Model's common language (coding), and XML as a shared protocol to ensure "quality by design" and reduce re-checking efforts. * **Impact of AI on TMF Operations:** The integration of artificial intelligence into TMF systems is a growing area, with implications for TMF metrics (e.g., measuring AI effectiveness/accuracy) and the need to adapt SOPs for AI coding, which will interact with inspection readiness and QC standards. * **Community-Driven Future Initiatives:** The TMF Reference Model actively seeks community input for future initiatives. Top priorities identified include developing a formal TMF Reference Model training course and exploring comprehensive coverage for all study types, including early phase and digital solutions/wearable devices. * **Bridging Clinical and Regulatory Documentation:** A recognized need exists to better integrate clinical and regulatory documentation, specifically addressing the overlap between TMF content and CTA (Clinical Trial Application) submission documents, especially with evolving European regulations. * **Importance of Metadata Standardization:** There is a recognized need to establish a more definitive set of minimal metadata per artifact within the TMF Reference Model to enhance data consistency and utility. * **Effective Communication and Engagement:** The TMF Reference Model encourages participation through its website (tmfr model.com), mailing list, forums for questions and feedback, and a LinkedIn group, emphasizing the importance of whitelisting their email for updates. **Tools/Resources Mentioned:** * **TMF Reference Model Website:** www.tmfr model.com (for resources, forums, joining mailing list, downloading documents) * **TMF Exchange Mechanism:** An XML-based technical standard for TMF data transfer, utilizing APIs and TMF Reference Model coding. * **LinkedIn Group:** A platform for community engagement and updates. **Key Concepts:** * **TMF (Trial Master File):** A collection of essential documents that individually and collectively permit the evaluation of the conduct of a clinical trial and the quality of the data produced. * **TMF Reference Model:** A standardized, hierarchical model for organizing TMF documents, providing a common structure, naming conventions, and minimal metadata. * **eTMF (Electronic Trial Master File):** A TMF managed electronically, often through specialized software systems. * **ICH GCP (International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – Good Clinical Practice):** An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. R2 and R3 refer to different revisions of these guidelines. * **Inspection Readiness:** The state of being prepared for regulatory inspections, ensuring all TMF documents are complete, accurate, and readily accessible. * **TMF Quality Control (QC):** Processes and procedures implemented to ensure the quality, completeness, and accuracy of TMF documents. * **TMF Metrics:** Quantitative measures used to assess the performance, completeness, and efficiency of TMF management processes. * **TMF Exchange Mechanism:** A technical standard designed to facilitate the secure and efficient transfer of TMF documents and associated metadata between different systems and organizations, preserving data quality. * **Sponsor:** The individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. * **CRO (Contract Research Organization):** An organization that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. * **Investigator Site File (ISF):** The collection of essential documents maintained by the investigator at the clinical trial site. * **Metadata:** Data that provides information about other data; in the TMF context, it describes characteristics of TMF documents (e.g., date, author, version). * **AI in TMF:** The application of artificial intelligence technologies to automate, optimize, and enhance various aspects of TMF management, such as document classification, quality control, and data analysis.
Nutrien's Commitment to Safety | ETQ
ETQ Reliance: Leading Quality Management System
/@ETQReliance
Jan 7, 2021
This video details Nutrien's strategic implementation of ETQ Reliance as its core platform for safety, health, and environment (SHE) management, following the company's formation in 2008 from the merger of Agrium and Potash Corp. The speaker, whose role was to evaluate all existing SHE software, describes the objective of identifying the "best of both companies" to establish a unified and robust safety culture. Nutrien's safety ethos is deeply rooted in a commitment to ensuring every worker gets "home safe every day," a principle they strive to tie back to their customers and overall company purpose. The evaluation process involved a thorough market analysis alongside leveraging prior knowledge of ETQ Reliance from one of the legacy companies. The platform was ultimately chosen for its proven capabilities and inherent flexibility, which were deemed critical for adapting to Nutrien's diverse and constantly growing global operations. The company successfully rolled out the platform across its North American legacy organization within a year, followed by global implementation in the subsequent year. This rapid deployment underscored the platform's adaptability to various business units and regulatory environments, a key factor in its success. The speaker emphasizes the inspiring nature of playing a part in such a critical initiative, highlighting the personal satisfaction derived from contributing to a culture where employee safety is paramount. The video effectively showcases how a large, complex organization can centralize and standardize its safety and environmental management processes through a flexible enterprise software solution. It illustrates the journey from a post-merger integration challenge to establishing a cohesive, scalable system that supports a fundamental corporate value: the well-being of its employees. Key Takeaways: * **Strategic Post-Merger Software Evaluation:** Following a significant merger, it is critical to conduct a comprehensive evaluation of existing software solutions across all operational areas, particularly for critical functions like safety, health, and environment (SHE), to identify the best-in-class tools and consolidate efforts. * **Culture-Driven Technology Adoption:** Nutrien's decision to implement ETQ Reliance was heavily influenced by its deeply ingrained safety culture, centered on the principle of "home safe every day." Aligning technology solutions with core company values can drive higher adoption and more effective outcomes. * **Importance of Platform Flexibility and Scalability:** The selection of ETQ Reliance was based on its known capabilities and flexibility, which proved essential for a global company with diverse business units and continuous growth. Enterprise software must be adaptable to evolving organizational structures and operational needs. * **Centralized SHE Management:** Implementing a single, core platform for "all things safety health and environment" provides a unified approach to managing critical risks, ensuring consistency in processes, and streamlining compliance across a large, distributed organization. * **Rapid Global Deployment Strategy:** Nutrien successfully deployed the platform across its North American operations in one year and globally in the next, demonstrating that rapid, phased rollouts are achievable with a flexible system and strong project management. * **Leveraging Prior Knowledge and Market Analysis:** The decision-making process combined internal knowledge of ETQ Reliance from a legacy company with external market analysis, ensuring both a proven track record and a best-fit solution were considered. * **Employee Engagement through Safety Initiatives:** The speaker's personal inspiration from contributing to employee safety highlights how robust safety programs, supported by effective technology, can foster a positive and committed work environment. * **Continuous Adaptation for Growth:** The world and the company are constantly growing, necessitating a SHE platform that can continuously adjust to new businesses, regulations, and operational complexities without slowing down critical safety processes. * **Integration for Comprehensive Compliance:** While not explicitly detailed in the transcript, the description of ETQ Reliance as a "Quality, EHS, Food Safety and Compliance management software" implies its role in integrating various compliance aspects, crucial for regulated industries. * **Proactive Risk Mitigation:** The use of a leading quality management system for identifying, mitigating, and preventing high-risk events through integration, automation, and collaboration is a best practice for maintaining operational excellence and regulatory adherence. Tools/Resources Mentioned: * **ETQ Reliance:** A leading Quality Management System (QMS) and EHS (Environmental, Health, and Safety) management software used by Nutrien as its core platform for safety, health, and environment. Key Concepts: * **Safety Culture:** The shared attitudes, beliefs, perceptions, and values that employees share in relation to safety. Nutrien's culture is based on "commitment" and the goal of "home safe every day." * **SHE (Safety, Health, and Environment) Management:** A systematic approach to managing risks related to occupational safety, employee health, and environmental protection within an organization. * **Quality Management System (QMS):** A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. In this context, it extends to safety and compliance. * **Enterprise Application Integration (EAI):** The process of connecting disparate applications within an organization to allow them to share data and business processes, crucial for a comprehensive platform like ETQ Reliance. Examples/Case Studies: * **Nutrien's ETQ Reliance Implementation:** A real-world example of a global agriculture company (formed from the merger of Agrium and Potash Corp. in 2008, with over 22,000 employees) successfully deploying a comprehensive SHE management system across its worldwide operations within two years.
Cloud-provider Veeva Systems CEO on supporting vaccine, drug development processes
CNBC Television
/@CNBCtelevision
Dec 22, 2020
This video provides an in-depth exploration of how Veeva Systems, an "industry cloud for life sciences," is driving the digitization of pharmaceutical and biotech companies, particularly in the context of vaccine and drug development. Peter Gassner, CEO of Veeva Systems, discusses with Jim Cramer the critical role of cloud software in accelerating the entire lifecycle of medicines, from clinical trials to commercialization and regulatory adherence. The conversation highlights the ongoing shift from traditional paper-based processes to digital solutions, emphasizing efficiency, compliance, and the long-term growth trajectory of the life sciences sector. Gassner elaborates on Veeva's comprehensive platform, which includes over 30 applications designed to support various stages of drug development and delivery. He cites prominent customers like Moderna, Pfizer, and Glaxo, underscoring Veeva's direct contribution to speeding up the end of the pandemic through its technology. A key theme is the significant, yet still early, transition from manual, paper-heavy operations, especially in large-scale clinical trials. Gassner projects a substantial reduction in paper usage in clinical development within a few years, reinforcing the idea that digitization is a future-proof trend for the two-trillion-dollar life sciences industry, independent of the immediate pandemic-driven demand. The discussion also delves into the evolving landscape of commercial operations and regulatory compliance within the pharmaceutical industry. Gassner acknowledges a potential shrinkage in sales forces (around 10%) due to increased efficiency driven by digital tools. He positions Veeva as a technology and data provider that enables this shift, supporting remote engagement with doctors through specialized, compliant software for activities like virtual meetings and digital sample signing. Furthermore, the interview touches on critical aspects such as cybersecurity vigilance against state-sponsored threats and the company's readiness to partner with administrations to navigate evolving regulatory environments, aiming to make healthcare more efficient and potentially less expensive through digitization. Key Takeaways: * **Veeva as the Industry Cloud:** Veeva Systems positions itself as the specialized "industry cloud for life sciences," offering a comprehensive platform with over 30 applications that support the entire drug lifecycle, from development and clinical trials to regulatory submissions and commercialization. * **Accelerating Drug Development:** Veeva's cloud software plays a crucial role in accelerating the development and delivery of medicines, including vaccines, by digitizing critical processes for major pharmaceutical companies like Moderna, Pfizer, and Glaxo. * **Digitization of Clinical Trials:** While significant progress has been made in commercialization, clinical trial management still heavily relies on paper-based processes. Veeva is actively working to digitize this area, with the CEO projecting a 50% reduction in paper usage within two to three years. * **Long-Term Industry Stability:** The life sciences industry is a massive, two-trillion-dollar sector critical for human health and happiness. Its growth and importance are long-term trends that predate COVID-19 and will continue long after the pandemic, dispelling concerns about post-pandemic decline. * **Impact on Commercial Operations:** Digitization is leading to increased efficiency in pharmaceutical commercial operations, potentially resulting in a 10% reduction in sales forces. This shift is beneficial for technology providers like Veeva, as companies adopt more digital tools to drive efficiency. * **Enabling Remote Engagement:** Veeva provides specialized software to facilitate remote interactions between pharmaceutical companies and healthcare professionals, such as compliant virtual meetings and digital signing for drug samples, adapting to the rise of telemedicine and remote work. * **Cybersecurity Vigilance:** Given the sensitive nature of pharmaceutical data and the high value of drug development, robust cybersecurity is paramount. Companies must assume constant threats and maintain vigilant defenses against attempts to access their systems. * **Regulatory Compliance Support:** Veeva's technology aids pharmaceutical companies in adhering to complex industry regulations. The company anticipates partnering with administrations worldwide to provide technology that supports better and more efficient healthcare, even with potentially stricter regulatory environments. * **Efficiency Drives Cost Reduction:** By digitizing and streamlining processes, Veeva contributes to making the overall value proposition of healthcare better and more efficient. This efficiency can ultimately lead to less expensive healthcare, though the distribution of these savings depends on administrative and policy decisions. * **Full Spectrum Support:** Veeva's applications cover the full spectrum of pharmaceutical operations, including manufacturing, clinical development, regulatory submissions, and patient outreach, demonstrating its integrated approach to industry challenges. **Tools/Resources Mentioned:** * **Veeva Systems Platform:** The core cloud-based software suite for life sciences. * **Veeva's 30+ Applications:** A suite of specialized software tools supporting various aspects of drug development, clinical trials, regulatory compliance, and commercial operations. **Key Concepts:** * **Industry Cloud:** A specialized cloud computing platform tailored to the unique needs and regulatory requirements of a specific industry, in this case, life sciences. * **Digitization of Life Sciences:** The ongoing process of converting information and processes from analog (e.g., paper) to digital formats and leveraging technology to improve efficiency, data management, and compliance across the pharmaceutical and biotech sectors. * **Remote Engagement:** The use of digital tools and platforms to facilitate interactions between pharmaceutical companies and healthcare professionals, replacing traditional in-person meetings.
Preview Increasing Speed & Accuracy of Remote Audits with Modern Cloud QMS
Veeva Systems Inc
/@VeevaSystems
Dec 17, 2020
This video provides an in-depth exploration of the challenges and best practices for conducting remote audits in the life sciences industry, particularly in the wake of the COVID-19 pandemic and the shift to virtual working environments. Featuring insights from quality experts at Merck & Co. and GlaxoSmithKline, alongside Veeva Systems, the discussion centers on how modern cloud solutions and adapted methodologies can enhance the speed and accuracy of virtual audits. The speakers delve into the practical difficulties encountered during remote audits and share lessons learned from their organizations' experiences. Ralph Mazenko, Executive Director of Clinical Quality Assurance at Merck, highlights several key challenges. He emphasizes the loss of non-verbal communication, specifically body language, as a significant impediment in virtual settings. Technical difficulties, or "snafus," such as struggling with mute buttons or inadvertently talking over others on platforms like MS Teams or Zoom, are also cited as common issues. Furthermore, scheduling complexities, especially across different time zones, contribute to the overall difficulty. Mazenko notes that remote audits often require more time than in-person audits because it's harder to cover the same number of topics, leading to auditors working longer hours even without travel. Marcus Massingham, Senior Director of Quality Systems at GlaxoSmithKline, expands on the technological and logistical hurdles. He points out the stark difference in documentation access between physical and virtual audits; in a physical setting, documents are readily available in a control room, whereas virtual audits necessitate an extra step for transmission, consuming valuable time. Massingham also addresses the challenges of connectivity and technology infrastructure within manufacturing or laboratory areas, which can impede attempts to conduct visual inspections or gather real-time information remotely. Both speakers underscore the need for organizations to adapt their audit plans and embrace new strategies to navigate these virtual complexities effectively. The discussion culminates in practical recommendations for improving the remote audit experience. Key lessons learned include the importance of scheduling fewer topics per audit with more allocated time for each, incorporating regular breaks to allow participants to gather requested information, and critically, providing opportunities for teams to practice using the technology without stress before a live audit. The overarching theme is that successful remote auditing requires not just technology adoption, but also a fundamental rethinking of processes, a focus on preparation, and an understanding of the unique human and technical dynamics of virtual interactions. Key Takeaways: * **Loss of Non-Verbal Cues:** Remote audits significantly suffer from the absence of body language and other non-verbal cues, making it challenging for auditors to fully understand context and nuances, which can impact the depth and accuracy of the assessment. * **Prevalence of Technology Snafus:** Basic technical difficulties, such as managing mute functions, avoiding speaking over others, or navigating virtual meeting platforms, are common and can disrupt the flow and efficiency of remote audit proceedings. * **Increased Time Allocation Required:** Virtual audits inherently demand more time per topic compared to in-person audits, as information exchange, clarification, and document review processes are often slower in a remote setting. * **Auditor Workload Intensification:** Despite eliminating travel, auditors frequently experience longer working days during remote audits due to the unique demands of virtual collaboration and the extended time required to complete tasks. * **Strategic Scheduling for Remote Audits:** To optimize efficiency and reduce fatigue, it is advisable to schedule fewer audit topics, allocate more time for each, and incorporate regular breaks to allow participants to gather information offline or rest. * **Mandatory Technology Practice:** Prior to a live remote audit, all participants should engage in stress-free practice sessions to familiarize themselves with the chosen virtual meeting platform and ensure seamless interaction and system access. * **Documentation Access and Transmission Challenges:** Unlike physical audits with centralized control rooms, virtual audits introduce an additional, time-consuming step for transmitting requested documentation, which requires robust digital processes. * **Connectivity and Infrastructure Limitations:** Conducting virtual inspections or gathering real-time data from manufacturing or laboratory facilities can be severely hampered by inadequate internet connectivity or insufficient technology infrastructure in those physical locations. * **Adaptation, Not Replication:** Organizations must recognize that remote audit processes cannot simply mirror traditional in-person methods; they require a fundamental re-evaluation and adaptation of methodologies, scheduling, and technological support. * **Continuous Learning and Improvement:** The life sciences industry is still in a learning phase regarding remote audits, emphasizing the need for ongoing evaluation, lessons learned sessions, and continuous improvement of virtual audit strategies.
Habit Action Veeva Oxford - New HQ Design & Build
Habit Action
/@habitaction2523
Dec 10, 2020
This video provides an in-depth look at the design and build of Veeva's new headquarters in Oxford, UK, as narrated by Sean Lorimer, the Facilities Manager for Veeva Oxford. The primary purpose of the video is to showcase the successful collaboration between Veeva and Habit Action, the design and build firm, in creating a modern, functional, and employee-centric workspace. The narrative highlights Veeva's corporate values, particularly its focus on employee well-being and fostering a positive work environment, which heavily influenced the office design. The project was executed during the challenging period of the COVID-19 pandemic, demonstrating effective remote collaboration and project management. The video details the process from the initial decision to move from their old buildings to the final completion of the new HQ. Sean Lorimer explains that Veeva sought a building that was "very corporate but fun, slightly individual," while still adhering to a global corporate image. Habit Action's approach involved a "Workplace Strategy process," which included extensive consultation with Veeva's team leads and key stakeholders to understand the unique operational needs of various departments. This meticulous understanding of user requirements, combined with a smooth design and build process, even amidst lockdown restrictions, resulted in a space that perfectly encapsulates Veeva's identity as a global software company in the pharmaceutical and tech sector. Key themes explored include the importance of a user-friendly and modern workspace, reflecting Veeva's tech-company identity while prioritizing employee comfort and collaboration. The office features a variety of spaces, including open-plan areas, comfortable huddle spaces, small meeting rooms with screens, and dedicated zones for different teams (e.g., global help desk and engineers separated from visitor areas). The design also incorporates elements like games in the kitchen and spaces for team-building events, reinforcing Veeva's people-focused culture. The seamless execution, constant communication via Zoom during lockdown, and the high quality of the final build, including specific details like lighting and "zoom rooms," are repeatedly praised by the client, underscoring the success of the project. Key Takeaways: * **Veeva's Corporate Culture and Values:** Veeva is portrayed as a "global software company" and "tech company" that is "very people focused" and "looks after their employees extremely well." This emphasis on employee well-being and a positive workspace environment is a core aspect of their brand and operational strategy. * **Strategic Workspace Design:** The new HQ was designed to be "very corporate but fun, slightly individual," balancing global corporate image with local autonomy. This approach ensures that physical spaces reflect and reinforce the company's brand identity and values. * **Importance of User Requirements:** Habit Action's success stemmed from taking the time to "fully understand Veeva's ways of working" by speaking to all team leads and key stakeholders. This deep dive into diverse team needs is crucial for creating truly functional and appreciated workspaces. * **Adaptability in Project Management:** The project was managed effectively despite the challenges of the COVID-19 pandemic, with constant meetings held via Zoom. This highlights the importance of flexible communication strategies and robust project management in adverse conditions. * **Seamless Collaboration:** The video emphasizes the "very smooth process" and "constant engagement" between the design firm and Veeva's teams, including stakeholders located internationally (e.g., Angel in Barcelona). Effective client-vendor collaboration is key to project success. * **Employee-Centric Design:** The office features a variety of spaces tailored for different activities and team needs, such as comfortable huddle spaces, open-plan areas, and dedicated quiet zones. This multi-functional design supports diverse work styles and promotes productivity and collaboration. * **Technology Integration in Workspace:** The design incorporates modern technology, including screens in all meeting rooms and "zoom rooms," reflecting Veeva's identity as a tech company and facilitating seamless communication and collaboration. * **Brand Reinforcement through Environment:** Veeva is "incredibly proud of their offices," viewing each as individual and a "perfect example of the thought that has gone into the design." Physical office spaces are seen as critical tools for attracting and retaining talent and reinforcing corporate pride. * **Strategic Zoning:** The layout strategically separates different functions, such as client waiting areas and training rooms from general working spaces and noisy global help desk/engineer teams. This ensures operational efficiency and minimizes distractions. * **Positive Client Testimonial Power:** Sean Lorimer's enthusiastic recommendation of Habit Action ("absolutely I would recommend Habit Action and have done so to quite a few companies already") underscores the value of delivering exceptional service and building strong client relationships. Tools/Resources Mentioned: * **Zoom:** Utilized extensively for meetings and collaboration during the COVID-19 lockdown. * **Veeva CRM (Implicit):** As Veeva is a "global software company" and a leader in the pharmaceutical and tech sector, their primary product, Veeva CRM, is implicitly central to their operations and identity. Key Concepts: * **Workplace Strategy Process:** A methodology used by Habit Action to thoroughly understand a client's operational needs, culture, and future growth plans before designing a workspace. * **Employee-Centric Design:** An approach to office design that prioritizes the comfort, well-being, and productivity of employees by offering diverse spaces and amenities. * **Corporate Image & Autonomy:** Balancing a consistent global corporate identity with the ability for individual country offices to have some unique design elements.
TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings
Kathy Barnett
/@kathybarnett4070
Nov 21, 2020
This video provides an in-depth exploration of regulatory expectations, inspections, and findings related to Trial Master Files (TMF) and electronic Trial Master Files (eTMF) in clinical investigations. Presented by Donna Dorinsky, a recognized subject matter expert in TMF and inspection readiness and a member of the TMF reference model steering committee, the session aims to equip participants with strategies for maintaining regulatory compliance and preparing for successful outcomes during TMF inspections. The overarching goal is to ensure that pharmaceutical companies are fully prepared from a TMF perspective when seeking regulatory approval for new drugs, emphasizing that the TMF is the complete narrative of a study. The presentation delves into the critical role of the TMF, describing it as "the story of your study"—a standalone set of documentation that should clearly articulate the entire trial without requiring extensive external explanation. Dorinsky shares a compelling anecdote about an FDA inspection where a meticulously remediated TMF led to an inspector concluding the TMF was in "excellent shape" after just three days, requiring minimal interaction with clinical personnel. This experience underscores the ideal state where the TMF itself provides a comprehensive and assessable record, enabling evaluation of trial conduct, data integrity, and compliance with Good Clinical Practice (GCP) standards. It is highlighted that the TMF represents a collective output of information from all functional areas involved in a study. A significant portion of the discussion focuses on essential documents, as defined by ICH E6, which are crucial for assessing trial conduct, data quality, and compliance with GCP. The video specifically references the 2016 revision, ICH E6 R2 (Integrated Addendum), which clarified expectations around TMF management. A key takeaway from this revision is the explicit requirement for both the sponsor and the investigator to maintain a record of the locations of their respective essential documents. Dorinsky emphasizes that regulatory bodies like the EMA and ICH consider the TMF to be comprised of documentation held by both the sponsor and the investigator (including site files). The speaker also addresses a practical challenge: even with the adoption of eTMF systems, it is rare for 100% of all essential documents to be consolidated in one single, human-readable format within a single system. Key Takeaways: * **TMF as the Study Narrative:** The Trial Master File (TMF) is fundamentally "the story of your study," serving as a standalone, comprehensive collection of documentation that should clearly explain the entire clinical trial without needing additional context. Its primary purpose is to ensure readiness for regulatory approval. * **Regulatory Inspection Readiness:** A well-maintained TMF is crucial for successful regulatory inspections. The speaker shared an experience where a highly organized TMF significantly streamlined an FDA inspection, demonstrating the power of a complete and accessible record. * **Core Functions of TMF:** The TMF enables the assessment of trial conduct, the evaluation of the integrity of trial data, and verification of compliance with Good Clinical Practice (GCP) standards, making it indispensable for regulatory oversight. * **Collective Effort:** The TMF is a collective output of information contributed by all functional areas involved in a clinical study, highlighting the need for cross-functional collaboration and standardized processes. * **Essential Documents Defined by ICH E6:** Essential documents, as defined in ICH E6, are those that individually and collectively permit the evaluation of trial conduct, data quality, and compliance of investigators, sponsors, and monitors with GCP standards. * **ICH E6 R2 Updates on TMF:** The 2016 ICH E6 R2 (Integrated Addendum) clarified that both the sponsor and the investigator are required to maintain a record of the locations of their respective essential documents, underscoring shared responsibility. * **Dual TMF Ownership:** Regulatory bodies like the EMA and ICH explicitly state that the TMF encompasses documentation held by both the sponsor and the investigator (including investigator site files), emphasizing a broader scope for TMF management. * **Challenges with eTMF Consolidation:** A practical challenge in TMF management is that even with electronic TMF (eTMF) systems, it is uncommon for 100% of all essential documents to be located and consolidated in a single, human-readable format within one system. * **Proactive CAPA Planning:** The presentation encourages participants to identify potential regulatory findings related to TMF and proactively develop Corrective and Preventive Action (CAPA) plans to address these issues, leading to successful inspection outcomes. * **Importance of Location Tracking:** Given that TMF documents may reside in multiple locations, maintaining an accurate record of where essential documents are held is a critical regulatory expectation. Tools/Resources Mentioned: * **TMF Reference Model:** A standardized, hierarchical model for classifying and organizing TMF documents, which the speaker is a steering committee member of. * **ICH E6 (R2) Integrated Addendum:** International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Guideline for Good Clinical Practice, Revision 2. Key Concepts: * **Trial Master File (TMF):** A collection of essential documents that individually and collectively permit the evaluation of the conduct of a clinical trial, the quality of the data produced, and the adherence to regulatory requirements. * **Electronic Trial Master File (eTMF):** A digital system for managing and storing TMF documents. * **Good Clinical Practice (GCP):** An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. * **Corrective and Preventive Actions (CAPA):** A system for identifying, documenting, and resolving non-conformances or deviations, and preventing their recurrence. * **Essential Documents:** Documents that permit the evaluation of the conduct of a trial and the quality of the data. * **Sponsor:** The individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. * **Investigator:** The person responsible for the conduct of the clinical trial at a trial site. * **Inspection Readiness:** The state of being prepared for regulatory inspections by ensuring all documentation and processes are compliant and accessible. Examples/Case Studies: * **FDA TMF Inspection Anecdote:** The speaker recounted an experience where nine months of work to remediate a TMF resulted in an FDA inspector declaring the TMF in "excellent shape" after just three days of a four-day inspection, requiring minimal interaction with clinical personnel. This highlights the effectiveness of a well-prepared TMF in streamlining regulatory reviews.
Digital transformation with Veeva Systems
The Innovation Coffee
/@theinnovationcoffee2510
Oct 27, 2020
This video explores the digital transformation within the life sciences industry, featuring David Logue, Senior Vice President of Veeva Commercial Strategy Europe. The discussion highlights Veeva Systems' pivotal role, its evolution from a software-centric company to one focused on software, data, and services, and the unique challenges and opportunities within the pharmaceutical sector. Logue emphasizes the importance of digital solutions in commercial, medical, and clinical operations, particularly in the context of accelerating change post-COVID-19, while also addressing key blockers to innovation such as change management and market timing. Key Takeaways: * **Veeva's Strategic Evolution:** Veeva has expanded its offering beyond pure software to a comprehensive "software, data, and services" model, reflecting the industry's need for integrated solutions that not only provide technology but also facilitate data interpretation and actionable insights. * **Pharma's Digital Maturity & Opportunities:** While the pharmaceutical industry excels in data utilization, it lags in customer experience compared to other sectors. This presents significant "runway" for digital innovation, especially in enhancing commercial and medical interactions, and developing patient-centric digital clinical trials. * **Underserved Medical Affairs:** Medical affairs is identified as a "massively underserved" area within the industry, with the pandemic underscoring the critical need for high-quality medical information and interactions. This points to a strong demand for AI and LLM solutions like medical info chatbots. * **Innovation Blockers: People and Timing:** The primary impediments to faster innovation are identified as "people change" (effective change management) and "timing." Innovations must be commercially viable and align with customer readiness, not just technological advancement, to succeed in the real world. * **COVID-19 as a Digital Catalyst:** The pandemic has significantly accelerated digital adoption and transformation within life sciences, forcing companies to pivot quickly and embrace new ways of engaging customers and patients, thereby creating a more receptive environment for innovative digital solutions. * **Data Value Through Services:** The mere existence of large data sets ("data lakes") is insufficient; true value is derived from the services that help analyze, interpret, and translate that data into meaningful business intelligence and actionable decisions. * **Deep Industry Specialization:** Veeva's success stems from its decision to "go deep" into the life sciences industry, recognizing its unique complexities and specific needs, which validates a specialized approach for technology and consulting firms in this sector.
How technology can simplify medical device regulatory compliance | Veeva Systems
Informa Connect Life Sciences
/@Ibclifesciences
Oct 27, 2020
This video provides an in-depth exploration of how technology can significantly simplify and enhance regulatory compliance within the medical device and diagnostics industry, particularly in light of evolving regulations like the EU MDR. Annemien Pullen, Director of Strategy for Vault Medical Devices & Diagnostics at Veeva Systems, outlines a strategic approach for companies to transition from reactive compliance management to a proactive, sustainable model enabled by robust technological solutions. The discussion begins by highlighting common regulatory challenges faced by medical device companies, such as fragmented data across organizations, inconsistencies in information, and a reliance on short-term workarounds. Dr. Pullen emphasizes that addressing these foundational issues through structural changes in regulatory operations, rather than temporary fixes, is crucial for long-term organizational sustainability. She underscores that despite external pressures like the COVID-19 pandemic and budget constraints, global regulatory changes, such as the EU MDR, are inevitable and require a strategic investment in a resilient regulatory operating model. Dr. Pullen elaborates on how technology acts as a powerful enabler, not an end goal, for optimizing the entire regulatory process. A single, global tool can harmonize business processes across different geographies and business units, providing leadership with real-time insights for informed decision-making. This approach significantly boosts efficiency by eliminating time wasted searching for data or the latest document versions. Critically, an effective Regulatory Information Management (RIM) system can track and trend health authority correspondence, allowing companies to anticipate questions, improve the quality of submission documents, and ultimately reduce time to market. This proactive stance also frees highly skilled regulatory professionals to focus on strategic intelligence and value-adding tasks rather than administrative burdens. The conversation concludes with essential considerations for selecting and implementing appropriate technology. Key factors include the system's security, its ability to facilitate secure internal and external collaboration (e.g., with economic operators and notified bodies for remote audits with granular access controls), and its overall usability. An intuitive user interface is paramount for high user adoption, ensuring the technology delivers its intended value. Furthermore, the chosen system must support the entire end-to-end regulatory process, functioning as more than just a data repository by enabling joint drafting, submission planning, product registration linking, and comprehensive correspondence tracking. Key Takeaways: * **Prioritize Structural Regulatory Change:** Medical device companies should focus on solving fundamental regulatory challenges like data sprawl and inconsistency through structural changes to their regulatory operating model, rather than relying on short-term workarounds. * **Invest in Organizational Sustainability:** View structural changes in regulatory operations as a critical investment in long-term organizational sustainability, especially given the continuous evolution of global regulations like the EU MDR. * **Leverage Technology as an Enabler:** Technology is not an end in itself but a powerful enabler for optimizing the end-to-end regulatory process, allowing for harmonization across business units and geographies. * **Shift to Proactive Compliance:** Implement technology to move from a reactive approach (responding to audits and non-conformities) to a proactive one, continuously monitoring the regulatory environment and maintaining compliance 24/7. * **Gain Real-time Insights and Efficiency:** A global regulatory tool provides leadership with real-time insights for better decision-making and increases efficiency by reducing time spent searching for data or managing disparate systems. * **Improve Submission Quality and Time to Market:** Utilize a robust RIM system to track and trend health authority correspondence. This intelligence allows companies to anticipate potential questions, improve the quality of initial submissions, and thereby reduce time to market. * **Empower Regulatory Professionals:** By automating administrative tasks and streamlining processes, technology enables highly skilled regulatory teams to focus on strategic activities, regulatory intelligence, and other value-adding tasks. * **Reduce Non-Compliance Issues:** An appropriate technology solution can significantly decrease non-compliance issues caused by human error or a lack of insight, contributing to a more robust compliance posture. * **Ensure High System Security:** When selecting a regulatory system, prioritize a high level of security, as it will serve as the single source of truth for sensitive regulatory documentation and process data. * **Facilitate Secure External Collaboration:** The system must support secure collaboration with external stakeholders, such as economic operators and notified bodies, by providing appropriate access rights and permissions for specific documents during remote audits. * **Emphasize Usability and Intuitive Design:** A user-friendly and intuitive interface is crucial for high user adoption. A modern system that is difficult to navigate will not deliver its full value, regardless of its features. * **Support End-to-End Regulatory Processes:** The chosen technology should be more than just a document repository; it must support the entire regulatory lifecycle, including joint drafting of submission documents, planning submissions, relating product registrations, and tracking health authority correspondence. **Key Concepts:** * **EU MDR (European Medical Device Regulation) & IVDR (In Vitro Diagnostic Regulation):** Key European regulations governing medical devices and in vitro diagnostic medical devices, driving significant changes in compliance requirements. * **Regulatory Operating Model:** The framework and processes an organization uses to manage its regulatory activities and ensure compliance. * **RIM System (Regulatory Information Management System):** A comprehensive software solution designed to manage all aspects of regulatory information, submissions, and compliance throughout the product lifecycle. * **Economic Operator Obligations:** Requirements placed on various entities in the supply chain (manufacturers, authorized representatives, importers, distributors) under regulations like the EU MDR. * **Notified Body:** An independent third-party organization designated by an EU member state to assess the conformity of certain products before they are placed on the market. * **Remote Audits:** Audits conducted remotely, often leveraging technology to provide auditors with access to necessary documentation and data without requiring physical presence. **Tools/Resources Mentioned:** * **Veeva Systems:** The speaker is from Veeva Systems, and the discussion implicitly refers to their suite of solutions, particularly Veeva Vault RIM, which addresses regulatory information management for the life sciences industry.
Demo: MarketBeam’s Social Media Integration with Veeva Vault PromoMats
Pushpa Ithal
/@pushpaithal8264
Oct 8, 2020
This video provides an in-depth exploration of how the highly regulated life sciences industry can effectively leverage social media for communication and engagement while maintaining strict compliance. Pushpa Ithal, the founder and CEO of MarketBeam, presents a solution that integrates MarketBeam's social media publishing, amplification, and analytics platform with Veeva Vault PromoMats. The presentation begins by highlighting the significant increase in social media usage for health and medical information, underscoring the urgent need for pharmaceutical, biotech, and medical device companies to engage with their audiences on these platforms. However, Ithal emphasizes the unique challenges faced by this industry, primarily the stringent regulatory requirements and the often inefficient, manual processes involved in content approval. The core of the discussion revolves around the inefficiencies of traditional social media content approval workflows in the life sciences sector. Ithal details how content creation, internal marketing review, preview generation, MLR/PRC committee review, and manual publishing often involve multiple teams, external agencies, and a cumbersome exchange of spreadsheets, emails, and images. This "old way" is not only resource-intensive but also lacks traceability and auditability, posing significant risks for non-compliant content publication and potential FDA audits. The speaker contrasts this with less regulated industries that can be far more agile and responsive on social media, highlighting the competitive disadvantage faced by pharma companies. MarketBeam's integration with Veeva Vault PromoMats is presented as a transformative solution to these challenges. The system automates several critical steps, from content creation and automatic preview generation (as a PDF) to direct submission into Veeva Vault PromoMats for approval. Once approved within Veeva, the content is automatically published to corporate social media channels (LinkedIn, Twitter, Facebook) at a scheduled time, eliminating manual intervention and reducing human error. Furthermore, the platform facilitates employee amplification of approved content, allowing colleagues to share compliant messages on their personal social media profiles, significantly expanding reach and engagement. The video concludes with a demonstration of the MarketBeam platform, showcasing its user interface for content creation, the seamless approval process within Veeva, automated publishing, and comprehensive analytics for tracking performance and engagement. Key Takeaways: * **Growing Importance of Social Media in Life Sciences:** Social media is increasingly used by consumers for health and medical information, with usage for health decisions rising from 25% in 2009 to over 52% in 2019. This necessitates that life sciences companies engage proactively on these platforms to reach their audiences. * **Regulatory Hurdles for Social Media Agility:** Unlike less regulated industries, pharmaceutical and life sciences companies face extensive compliance requirements (e.g., MLR/PRC review, FDA 2253 submissions) for all content, including social media posts, which significantly slows down publishing and limits agility. * **Inefficiencies of Manual Approval Processes:** Traditional workflows for social media content approval are highly inefficient, relying on manual steps, spreadsheets, emails, and multiple team hand-offs (marketing, branding, MLR/PRC, external agencies), leading to resource-intensive operations and delays. * **High Risk of Non-Compliance:** The manual nature of current processes increases the risk of publishing unapproved or non-compliant content, which can have severe consequences for brands and even individual employees who share content. * **Lack of Traceability and Auditability:** Manual processes often lack a clear audit trail, making it extremely difficult to trace who created, reviewed, and approved content, and when, which is critical for regulatory audits (e.g., FDA). * **MarketBeam-Veeva Vault PromoMats Integration:** MarketBeam offers a specialized integration with Veeva Vault PromoMats, leveraging Veeva's established digital asset management and robust approval processes to streamline social media content workflows. * **Automated Content Workflow:** The integration automates several steps: content creation in MarketBeam, automatic generation of PDF previews, direct submission to Veeva Vault PromoMats for MLR/PRC review, and automated publishing to social media channels upon approval. * **Reduced Human Error and Increased Efficiency:** By automating the approval and publishing process, the solution significantly reduces the potential for human error, accelerates content delivery, and frees up resources. * **Employee Amplification of Compliant Content:** The platform enables employees to connect their personal social media accounts and share pre-approved, compliant content, vastly extending the reach and impact of corporate messaging while mitigating compliance risks. * **Comprehensive Analytics and Insights:** MarketBeam provides integrated analytics dashboards that track hourly engagement, identify top-performing content and channels, and offer insights into audience behavior, helping companies optimize their social media strategy. * **Global Applicability:** The workflow and integration are designed to be globally applicable, accommodating various regional compliance requirements, though specific regulations will still need to be managed within the Veeva system. * **Support for Multiple Social Networks:** MarketBeam currently supports LinkedIn, Twitter, and Facebook, with plans to expand to Instagram and Xing, catering to a broad range of social media strategies. Tools/Resources Mentioned: * **MarketBeam:** A social media publishing, amplification, and analytics platform. * **Veeva Vault PromoMats:** A digital asset management and content approval platform widely used in the pharmaceutical industry. * **LinkedIn, Twitter, Facebook:** Social media platforms supported for publishing and amplification. * **Instagram, Xing:** Social media platforms planned for future support. Key Concepts: * **MLR/PRC Committee:** Medical, Legal, and Regulatory / Promotional Review Committee, responsible for reviewing and approving all content in the life sciences industry to ensure compliance. * **FDA 2253:** A specific FDA requirement in the US for submitting promotional materials to the agency before or at the time of initial dissemination. * **Auditability and Traceability:** The ability to track and verify the entire lifecycle of a piece of content, including its creation, review, approval, and publication, which is crucial for regulatory compliance. * **Employee Amplification:** A strategy where employees share approved corporate content on their personal social media channels to extend reach and credibility.
Introduction to Veeva SiteVault
Veeva SiteVault
/@VeevaSiteVault
Sep 28, 2020
This video provides an introductory overview of Veeva SiteVault, a dedicated electronic regulatory system designed for research sites to manage their essential study documents. The presentation establishes SiteVault as a modern solution to replace traditional paper-based regulatory binders, also known as Investigator Site Files (ISF), and shared digital drives. It emphasizes SiteVault's role in centralizing and streamlining the management of regulatory documents, clinical resource documents, and staff profile documents (such as CVs, medical licenses, and training credentials), making them accessible from anywhere with an internet connection without requiring local installations or downloads. A crucial distinction highlighted is that SiteVault is not a sponsor portal; instead, it's a site-owned system, granting sites full control and ownership over their documents and data. The video delves into the inherent challenges of traditional document management systems, such as paper binders or generic shared drives. These methods often lead to difficulties in defining consistent folder structures, relying on memory to locate documents, ensuring security, controlling access, and preventing misplacement. The speaker illustrates these problems with common questions like "Where was this document saved?" or "Is this the most current version?" Veeva SiteVault addresses these issues by adopting a document-centric approach. Instead of organizing by folders, documents are stored based on their content and metadata, allowing for easy retrieval through a robust search function. This eliminates the need for users to remember specific storage locations, ensuring that the correct and most current version of a document is always accessible. Furthermore, the presentation explains key concepts underpinning SiteVault's functionality, including document versioning and document states. It supports both major and minor version numbers, crucial for maintaining an accurate audit trail and compliance. Documents progress through different states (e.g., draft, final), and access can be controlled based on these states, ensuring that external parties like monitors only view appropriate versions. SiteVault facilitates paperless operations by enabling electronic signatures, reducing the need for printing, scanning, and faxing. It also centralizes staff credentials, automatically updating CVs, licenses, and training records across all studies a team member is involved in, significantly reducing administrative burden and ensuring consistency. The system also allows for secure access provision to external monitors, eliminating the need for sites to upload documents into various sponsor portals. Finally, it offers reporting and dashboard capabilities to track upcoming expiration dates, open tasks, and overall document status, enhancing oversight and compliance. Key Takeaways: * **Electronic Investigator Site File (eISF):** Veeva SiteVault serves as an electronic regulatory system specifically designed for research sites to manage their Investigator Site Files (ISF) and other essential regulatory and source documents, replacing traditional paper binders. * **Site Ownership and Control:** Unlike sponsor portals, SiteVault is a site-owned system, giving research organizations complete control and ownership over their documents and data, ensuring independence and data integrity. * **Document-Centric Approach:** The system moves away from folder-based organization, storing documents based on their content and metadata. This allows for powerful search capabilities, making it easy to find any document without remembering its specific storage location. * **Enhanced Security and Accessibility:** Documents are securely stored and accessible from anywhere with an internet connection, eliminating the security risks and access limitations associated with physical binders or generic shared drives. * **Robust Version Control:** SiteVault automatically manages major and minor document versions, ensuring that the most current and accurate document is always available while maintaining a complete audit trail of changes, critical for regulatory compliance. * **Controlled Document States:** Documents progress through defined states (e.g., draft, final), and access permissions can be configured based on these states, allowing for granular control over who can view or interact with a document at different stages. * **Streamlined Paperless Workflows:** The platform supports electronic signatures and digital workflows, significantly reducing the need for printing, scanning, and faxing, thereby improving efficiency and reducing operational costs. * **Centralized Credential Management:** Staff CVs, medical licenses, and training credentials can be centralized within SiteVault. When updated, these credentials automatically propagate across all studies the staff member is associated with, ensuring consistency and reducing administrative overhead. * **Secure External Monitor Access:** Sites can provide secure, controlled access to external monitors directly within SiteVault, eliminating the redundant and often cumbersome process of uploading documents to multiple sponsor-specific portals. * **Comprehensive Reporting and Dashboards:** The system offers built-in reporting and dashboard functionalities to track critical information such as upcoming expiration dates for documents or staff credentials, open tasks, and overall document status, aiding in proactive management and compliance. * **Scalability for Multiple Studies:** SiteVault is designed to manage an unlimited number of studies, documents, and users, making it a scalable solution for growing research organizations. Key Concepts: * **Regulatory Binder / Investigator Site File (ISF):** A collection of essential documents maintained by the investigator at the study site, demonstrating compliance with regulatory requirements and the integrity of the data produced. * **eISF (Electronic Investigator Site File):** The digital equivalent of the traditional paper ISF, managed electronically within a system like Veeva SiteVault. * **Source Documents:** Original documents, data, and records (e.g., patient charts, lab results) that are used in a clinical trial. * **Document Versioning:** The process of tracking and managing changes to documents over time, including major and minor revisions, to ensure an accurate history and access to the correct version. * **Document States:** The different stages a document goes through in its lifecycle (e.g., Draft, In Review, Final, Archived), often dictating access permissions and workflow actions. * **Metadata:** Data that provides information about other data, such as the document type, author, creation date, and associated study, used by SiteVault for intelligent organization and search. * **Sponsor Portal:** A system provided by a study sponsor for sites to upload documents related to a specific clinical trial. Veeva SiteVault is distinct as it is site-owned and not limited to a single sponsor's study. Tools/Resources Mentioned: * **Veeva SiteVault:** The primary platform discussed, designed for electronic regulatory document management for research sites.
AMPscript preference centres and segmentation in SFMC using DESelect
Andrei Barany
/@andreibarany
Sep 24, 2020
This video provides an in-depth exploration of two critical aspects of Salesforce Marketing Cloud (SFMC): simplifying data segmentation for marketers and building highly customized preference centers. The content is presented through two distinct segments from a Salesforce Marketer Group meetup. The first segment, led by Gregory from DESelect, introduces a drag-and-drop solution for audience segmentation, aiming to reduce reliance on complex SQL queries. The second segment, presented by Kayode Adeniji, a Solution Architect, delves into the creation of custom preference centers using AMPscript, highlighting the benefits of enhanced branding, personalization, and compliance over SFMC's standard offerings. The first presentation focuses on DESelect, an AppExchange solution designed to empower marketers to perform complex data segmentation within SFMC without needing technical SQL expertise. Gregory explains that data challenges in marketing cloud, such as disparate data sources, varying data types, and duplicates, often lead marketers to use cumbersome methods like Excel or require specialized SQL knowledge. DESelect aims to resolve this by providing an intuitive, integrated platform where data remains within SFMC, ensuring security and compliance. The demo showcases a three-step process: defining selection criteria (source data extensions, relationships, filters), creating a target data extension (defining fields, send relationships), and previewing results before execution. This approach significantly reduces the time spent on data management, freeing marketers to focus on campaign strategy and content. The second presentation by Kayode Adeniji addresses the limitations of SFMC's out-of-the-box preference center and demonstrates how to build a fully branded and personalized custom preference center using AMPscript and Cloud Pages. Kayode emphasizes that while the standard preference center fulfills basic compliance needs, it lacks the flexibility for advanced branding, custom fields, and dynamic content. His use case involves a preference center that dynamically displays content in English or French based on subscriber language preference, alongside profile updates. The demo illustrates the interplay between an email link, a preference data extension, a language label data extension, and multiple Cloud Pages (main preference, profile update confirmation, full unsubscribe confirmation). AMPscript is shown to be central to pre-populating fields, updating subscriber data in data extensions, and managing the "All Subscribers" list status (active/unsubscribed), ensuring both personalization and regulatory compliance. Key Takeaways: * **Simplifying SFMC Segmentation:** Traditional segmentation in Salesforce Marketing Cloud often requires technical skills like SQL, which can be a significant barrier for marketers. Solutions like DESelect offer a drag-and-drop interface, making complex segmentation accessible to non-technical users. * **Benefits of No-Code Segmentation:** DESelect's approach saves up to 50% of time spent on data management, allowing marketers to launch more campaigns and improve marketing ROI. It also minimizes errors associated with manual data handling or complex SQL queries. * **Data Security and Integration:** DESelect processes data directly within Salesforce Marketing Cloud, ensuring that sensitive information does not leave the platform, which is crucial for organizations with strict data security and regulatory compliance requirements. * **Limitations of Standard Preference Centers:** Salesforce Marketing Cloud's default preference center lacks branding flexibility, customization options for layout and font, and advanced personalization capabilities, leading to a less engaging subscriber experience. * **Advantages of Custom Preference Centers:** Building a custom preference center allows for a full branded experience, creation of custom profile fields, advanced personalization (e.g., dynamic language display), and direct synchronization of preference changes with other CRM instances like Sales Cloud. * **Core Components for Custom Preference Centers:** Essential elements include a preference center link in emails, a dedicated data extension to store subscriber preferences and profile attributes, a separate data extension for multi-language labels, and multiple Cloud Pages for the main preference form and various confirmation messages. * **AMPscript for Dynamic Functionality:** AMPscript is the proprietary scripting language used in SFMC to power custom preference centers. It handles pre-population of fields, dynamic content rendering (e.g., language-specific labels), capturing user input, updating data extensions, and managing subscriber status in the "All Subscribers" list. * **Dynamic Language Labels:** Utilizing a data extension to store labels for different languages (e.g., English, French) allows the preference center to dynamically display content in the subscriber's preferred language without hardcoding, making the code cleaner and easier to update for additional languages. * **Managing Subscriber Status and Compliance:** Custom preference centers must effectively manage subscriber opt-in/opt-out status. AMPscript can update specific preference fields in data extensions and crucially, update the "All Subscribers" list status (active/unsubscribed) to ensure compliance with regulations like CAN-SPAM. * **Automation for Segmentation:** While custom preference centers collect detailed preferences, marketers often need to create automation studio queries or segments based on these updated preferences to ensure targeted email delivery, rather than relying solely on publication lists. Tools/Resources Mentioned: * **DESelect:** A drag-and-drop segmentation solution for Salesforce Marketing Cloud. * **Salesforce Marketing Cloud (SFMC):** The primary platform discussed for email marketing, segmentation, and preference management. * **AMPscript:** Salesforce Marketing Cloud's proprietary scripting language used for dynamic content and data manipulation. * **Cloud Pages:** A module within SFMC for building micro-sites and landing pages, used to host the custom preference center. * **Content Builder:** SFMC tool for creating and managing email content, including preference center links. * **Email Studio:** SFMC module for managing email campaigns. * **Automation Studio:** SFMC tool for automating marketing tasks, including segmentation based on preferences. * **Sublime:** A text editor mentioned for reviewing AMPscript code. * **AppExchange:** Salesforce's marketplace for applications, where DESelect is available. Key Concepts: * **Data Extensions:** Tables within Salesforce Marketing Cloud used to store subscriber data, preferences, and other relevant information. * **All Subscribers List:** The master list in SFMC that contains all marketable contacts for the email channel and their subscription status (active, unsubscribed). * **Publication Lists:** Optional lists in SFMC used to manage subscriber preferences for different types of communications. * **SQL Queries:** Structured Query Language used for managing and querying data in relational databases, often used for advanced segmentation in SFMC. * **Inner Join/Outer Join/Exclusions:** SQL concepts used to combine or filter data from multiple data extensions based on specified relationships. * **Deduplication Logic:** Rules defined to handle duplicate records in data extensions, ensuring data accuracy. * **Sendable/Testable Data Extensions:** Data extensions configured to be used for sending emails or testing campaigns. * **RequestParameter Function (AMPscript):** An AMPscript function used to retrieve values passed via URL parameters or form submissions. * **Lookup Function (AMPscript):** An AMPscript function used to retrieve data from a data extension based on specified criteria. * **UpdateData Function (AMPscript):** An AMPscript function used to update records in a data extension. * **UpdateSubscriber API (AMPscript):** An AMPscript function used to update a subscriber's status and attributes in the "All Subscribers" list. Examples/Case Studies: * **Cambridge University Press:** A DESelect success story where the organization reduced the time taken for data segmentation from several days to less than five minutes, significantly improving efficiency. * **Practicing Institute:** Another DESelect client that chose to invest in DESelect rather than in costly and time-consuming SQL training for their marketing team, enabling marketers to segment data without technical knowledge. * **Custom Preference Center Demo:** A detailed walkthrough of a custom preference center built with AMPscript, demonstrating dynamic language switching (English/French), profile information updates (first name, last name, email), and preference management for different communication types (news, promotions, SFMC tips). The demo also illustrated the update of subscriber status in the "All Subscribers" list for both profile updates and full unsubscribes.
Bree Burks of Veeva Systems Discusses What Clinical Trials Will Look Like Post COVID-19
To Be Frank
/@therealtobefrank
Sep 9, 2020
This.ai offers its services. The conversation extensively covers the role of technology, data management, and operational efficiency in clinical researchai specializes in consulting for. This video explores the significant transformation of clinical trials post-COVID-19, highlighting the accelerated shift towards remote, decentralized, and virtual models. Bree Burks from Veeva Systems discusses the historical challenges faced by research sites, particularly their reliance on manual, paper-based processes and the lack of dedicated technology budgets. She emphasizes Veeva's approach to empowering sites and patients through purpose-built, affordable technology like SiteVault Free for eRegulatory management and MyVeeva for patient engagement. A major theme is the inefficiency of the study startup process, which accounts for a disproportionate amount of trial time due to manual workflows and disconnected systems, underscoring the critical need for standardization and unified technology platforms across the industry. Key Takeaways: * **Accelerated Decentralization:** The COVID-19 pandemic significantly accelerated the adoption of remote, decentralized, and virtual clinical trials, making patient and site-centricity paramount in trial design and technology implementation. * **Site Empowerment Through Technology:** Research sites historically lacked adequate technology and operated with limited financial reserves. Solutions like Veeva's SiteVault Free provide essential, affordable tools for sites to standardize, go paperless, and manage remote monitoring, enabling them to operate more efficiently and sustainably. * **Critical Study Startup Inefficiencies:** Study startup accounts for a staggering 61% of total trial time, primarily due to manual processes (75% prevalence), heavy reliance on error-prone spreadsheets (81%), and a lack of transparency and connected systems between sponsors, CROs, and sites. * **The Imperative for Standardization and Unified Platforms:** To overcome operational drag and reduce "one-off" approaches to studies, there is a strong need for standardization of processes and the adoption of seamlessly unified technology platforms that facilitate automated data and document exchange across all stakeholders. * **Patient-Centric Technology for Accessibility:** New technologies like MyVeeva aim to bring clinical trials directly to patients, particularly those in rural areas or with rare diseases, by enabling virtual visits and streamlined communication, thereby enhancing diversity and accessibility in trials. * **Technology Must Simplify, Not Complicate:** The ultimate goal of technology in clinical trials must be to simplify site operations and reduce administrative burden, allowing sites to remain focused on patient care and accelerate therapy development, rather than creating additional bureaucratic layers or compliance concerns.
Continuous Improvement by Paul R Palmer Limited
Pharmaceutical consultant QP | Paul R Palmer
/@paulrpalmer
Aug 27, 2020
This video explores the critical concept of continuous improvement (CI) within the pharmaceutical industry, emphasizing its strategic value beyond daily operational tasks. The speaker, Paul Palmer, argues that focusing on CI—by making processes better, improving deliveries, and reducing complaints—can lead to significant benefits such as increased output and enhanced customer retention. He provides practical, pharmaceutical-specific examples, discussing challenges like balancing packaging regulations with patient needs (e.g., legible text for older patients) and improving product accessibility for specific patient populations (e.g., arthritis sufferers opening blister packs). The video also delves into optimizing customer service response times for treatment-critical issues and improving manufacturing efficiency by identifying bottlenecks and waste through methods like video analysis and downtime logging. Key Takeaways: * **Strategic Imperative of Continuous Improvement:** Continuous improvement is presented as a vital strategy for pharmaceutical companies to achieve substantial gains in output and customer loyalty, rather than just focusing on day-to-day product delivery. * **Pharma-Specific Operational Challenges & Solutions:** The video offers concrete examples of CI application in the pharmaceutical sector, addressing issues such as regulatory compliance conflicting with patient usability (e.g., small print on packaging) and product design for specific patient needs (e.g., ease of opening blister packs for arthritis patients). * **Optimizing Pharmaceutical Customer Service:** A strong emphasis is placed on the need for rapid and prioritized responses to customer inquiries, particularly when treatment is time-sensitive, suggesting solutions like standardized responses, frequently asked questions (FAQs), and leveraging patient information leaflets. * **Data-Driven Process Enhancement:** Practical methods for identifying areas for improvement are highlighted, including monitoring performance metrics (deviations, complaints), utilizing video analysis to pinpoint waste and stop points in manufacturing, and implementing simple log sheets for downtime. * **Balancing Compliance and Innovation:** The discussion implicitly touches on the delicate balance between adhering to strict pharmaceutical regulations (e.g., packaging size, product integrity) and innovating to improve patient experience and operational efficiency.
TMF Risk Base Quality Control
Phlexglobal - a Cencora PharmaLex company
/@Phlexglobal
Aug 24, 2020
This video provides an in-depth exploration of Trial Master File (TMF) risk-based quality control (QC), addressing the persistent challenges faced by clinical trial sponsors and Contract Research Organizations (CROs in achieving TMF health and inspection readiness. The presenter begins by highlighting the omnipresence of TMF QC discussions at conferences, underscoring the industry's struggle to efficiently implement quality control and review activities. Drawing upon ICH E6 R2 guidelines, the video defines quality control as operational techniques and activities within a quality assurance system designed to verify that trial-related activities meet quality requirements. This foundational definition emphasizes the need for QC to be embedded under a predefined, documented regime and executed according to specific quality level requirements, including a crucial verification step often misunderstood. The core of the discussion revolves around how to effectively meet these QC requirements, particularly in the context of a TMF. ICH E6 R2 advocates for QC activities to focus on aspects essential for human subject protection and trial result reliability, acknowledging that not all TMF management aspects directly impact subject safety or data integrity. This principle of proportionality is further reinforced by EMA guidelines, which explicitly recommend implementing risk-based quality checks or review processes. The video then introduces a structured, four-step risk-based approach: identification of critical processes and data, identification and assessment of risks, implementation of risk controls through tailored quality review, and robust risk communication, review, and reporting. The first step, identification of critical processes and data, involves assessing TMF content to pinpoint documents or artifacts with the potential to adversely impact subject protection and data reliability. The video notes the absence of an industry standard classification, necessitating each sponsor to make its own determination, suggesting categorization into criticality groups (e.g., high, medium, low) or assigning impact scores. The second step focuses on identifying and assessing risks, outlining three primary TMF management risks: poor document quality (not meeting GCP/internal requirements), incorrect filing (poor indexing), and missing documents. Risk assessment can involve evaluating the effort required to demonstrate compliance in case of quality issues, or, more effectively, leveraging empirical data from eTMF systems. A purpose-built eTMF can provide metadata on document availability, due dates, and study milestones, allowing organizations to identify artifacts frequently filed late or incorrectly and assign them to appropriate risk groups. The final two steps detail risk controls and communication. Step three, risk controls, advocates for implementing tailored quality review processes rather than a one-size-fits-all approach. Based on risk categorization, some artifacts may require no review, others 100% review, and many can be managed through sampling. A critical warning is issued against using spreadsheets for managing QC activities, citing their resource intensiveness, error proneness, and potential to contribute to inspection findings. Instead, the video stresses that eTMF systems should be capable of identifying artifacts due for QC, tracking issues, and ensuring resolution. Step four, risk communication, review, and reporting, highlights the eTMF's role in efficiently communicating TMF status, outcomes, and trends. It emphasizes that a TMF quality regime should be cyclical, with QC failure data feeding back into future review activities, enabling continuous improvement and allowing high-risk artifacts to potentially become low-risk over time through timely escalation and user education. Key Takeaways: * **Definition of Quality Control (QC):** According to ICH E6 R2, QC involves operational techniques and activities within a quality assurance system to verify that trial-related activities fulfill quality requirements, necessitating a predefined, documented regime and specific quality level understanding. * **Requirements for Effective QC:** Effective TMF quality control requires embedding activities within a quality assurance system under a predefined and documented regime, and executing them according to specific quality level requirements, including a verification step (quality review). * **Principle of Risk-Based QC:** QC activities should be proportionate to the risks inherent in the trial and the importance of the information collected, focusing on aspects essential for human subject protection and reliability of trial results, as mandated by ICH E6 R2 and EMA guidelines. * **Four-Step Risk-Based Approach:** A comprehensive risk-based TMF QC strategy involves (1) identification of critical processes and data, (2) identification and assessment of risks, (3) implementation of risk controls (quality review), and (4) risk communication, review, and reporting. * **Criticality Assessment:** Identifying critical TMF artifacts requires assessing their potential to adversely impact subject protection and data reliability. There is no industry standard classification, so sponsors must determine their own, often categorizing documents into high, medium, or low criticality groups or assigning impact scores. * **Primary TMF Management Risks:** The three main risks in TMF management are documents not meeting GCP/internal requirements (poor quality), incorrect filing (poor indexing), and documents missing from the TMF. * **Empirical Data for Risk Assessment:** Leveraging eTMF system metadata is crucial for identifying risks. Data on document availability compared to due dates or study milestones can reveal artifacts frequently filed late or not at all, allowing for data-driven risk grouping. * **eTMF for Quality Issue Tracking:** Purpose-built eTMF solutions with embedded quality review workflows can capture QC rejections and reasons (e.g., missing signatures, page numbers), providing empirical data to identify artifacts most frequently indexed incorrectly or containing content errors. * **Impact of Document Lifecycle and Active Use:** Documents undergoing content review and inline approval workflows in the eTMF are likely to have fewer quality issues. Similarly, documents actively referenced by study team members tend to have quality issues highlighted sooner, making unreferenced documents higher risk. * **Defining a Comprehensive QC Strategy:** An effective QC strategy considers four factors: artifact impact on patient safety/rights/data integrity, effort to demonstrate compliance where quality issues exist, likelihood of quality issues based on empirical data, and robustness of document review processes. * **Tailored Quality Review:** Risk controls involve configuring different review activities based on risk categorization. Some low-risk, non-critical artifacts may not need review, while high-risk ones might require 100% review, and others can use sampling. * **Warning Against Spreadsheets for QC:** Managing quality review activities with spreadsheets is highly discouraged due to being resource-intensive, error-prone, and confusing. A sponsor's root cause analysis revealed Excel use for tracking periodic reviews as a major contributor to critical inspection findings. * **Importance of Purpose-Built eTMF:** A dedicated eTMF built on TMF best practices is essential for efficient risk communication, review, and reporting, enabling easy surfacing, reporting, and escalation of TMF status, outcomes, and trends, which general document management systems or spreadsheets cannot do well. * **Cyclical Quality Improvement:** A TMF quality regime should be cyclical, with data on QC failures feeding back into future quality review activities. This continuous feedback loop, combined with timely escalation and user education, can lead to ongoing productivity and quality improvements. **Tools/Resources Mentioned:** * **eTMF Systems:** Purpose-built electronic Trial Master File solutions are highlighted as critical for managing metadata, workflows, tracking QC issues, and generating empirical data for risk assessment and reporting. * **Anonymized Data Warehouse of eTMF Metadata:** A select few eTMF providers can offer access to anonymized data warehouses, enabling organizations without sufficient historical data to identify quality trends across numerous sponsors. **Key Concepts:** * **Trial Master File (TMF):** A collection of essential documents that individually and collectively permit evaluation of the conduct of a clinical trial and the quality of the data produced. * **Quality Control (QC):** Operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled. * **Quality Assurance (QA):** The overall system that ensures the quality of the trial. * **ICH E6 R2:** International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Guideline for Good Clinical Practice (GCP), an internationally accepted standard for clinical trials. * **EMA Guidelines:** European Medicines Agency guidelines, specifically on the content, management, and archiving of the clinical trial master file. * **Good Clinical Practice (GCP):** An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. * **Risk-Based Quality Control:** An approach to QC that focuses resources and efforts on the aspects of a trial that are most critical to human subject protection and data reliability, proportionate to the risks involved. * **Critical Process/Data:** Elements within the TMF whose potential failure or inaccuracy could significantly impact subject protection, data reliability, or regulatory compliance. * **Risk Control:** The implementation of tailored quality review processes and other measures to mitigate identified risks. * **Risk Communication, Review, and Reporting:** The systematic process of sharing information about TMF risks, monitoring their status, and reporting on their management and outcomes. **Examples/Case Studies:** * **Excel for QC Tracking Pitfall:** A sponsor at a TMF Summit in Orlando (January 2019) performed a root cause analysis for critical inspection findings and discovered that a major contributing factor was the use of Excel spreadsheets for tracking their periodic reviews, highlighting the dangers of inadequate system support for QC.
![How to Choose and Implement the Right eQMS for Your Company [The Qualitalks Podcast]](https://i.ytimg.com/vi_webp/dfpk616joE8/maxresdefault.webp)
How to Choose and Implement the Right eQMS for Your Company [The Qualitalks Podcast]
Qualistery - GMP Content
/@Qualistery
Aug 9, 2020
This video provides an in-depth exploration of Electronic Quality Management Systems (eQMS) and their pivotal role in the digital transformation of the pharmaceutical and life sciences industries. The host, Yan Kugel, interviews Doron Sitbon, CEO of Dot Compliance, a SaaS provider of eQMS solutions. The discussion centers on the imperative for companies to embrace digitalization, the challenges and benefits associated with this shift, the different types of eQMS available, and best practices for successful implementation. Sitbon emphasizes that digital transformation is not merely a technological upgrade but a fundamental change in how quality and compliance are managed, impacting efficiency, cost, and ultimately, patient safety. The conversation highlights the significant increase in the cost of bringing new pharmaceutical products to market—from $0.8 billion 15 years ago to $2.5-$2.6 billion today—primarily due to the escalating demand for data and regulatory evidence. An eQMS helps address this by ensuring all data, even from early R&D stages, is captured and tracked in a compliant manner, providing the confidence regulators require. While acknowledging the inherent fear of change and the heavy burden of validation and documentation in a regulated environment, Sitbon argues that modern eQMS solutions, like Dot Compliance, are designed to alleviate this "heavy lifting" by offering ready-to-use, validated systems that provide a contemporary user experience without compromising data integrity or regulatory adherence. The benefits are substantial, including 20-30% savings in operating costs related to data management, accelerated processes, and a unified "single source of truth" for all stakeholders. The discussion further delves into the evolution of quality management, moving from isolated, paper-based systems or disconnected digital "islands" to harmonized, platform-based solutions. This shift redefines the role of Quality Assurance (QA) professionals, transforming them from "paper pushers" to "gatekeepers" and, in the future, to "cyber analysts" who interpret vast amounts of structured and unstructured data to make risk-based decisions. The video also stresses the growing importance of seamless collaboration within the supply chain, particularly with Contract Manufacturing Organizations (CMOs), where a significant portion of a pharmaceutical company's assets and risks reside. Modern eQMS, Sitbon explains, must facilitate this partnership by enabling secure and efficient information sharing. When choosing an eQMS, companies should evaluate traditional ERP systems, legacy QMS software, and modern cloud-based platforms that leverage existing robust technologies, focusing on industry-specific expertise, ease of deployment, and ongoing support for regulatory updates and audits. Finally, Sitbon outlines a strategic approach to eQMS implementation. This involves assembling a dedicated team, including QA subject matter experts, an executive sponsor (e.g., Head of QA, Operations, or CEO), and strong IT support, especially for mid-sized organizations. The team must define a clear scope, build a realistic transition plan, and actively manage organizational change, understanding the internal culture and winning over employees. A practical deployment strategy, dubbed the "rule of three," suggests focusing on three major processes for initial deployment within three months. The overall goal for a mid-sized manufacturing organization, with the right prerequisites, is to digitalize 90% of its processes within a year. The success hinges on persistence, clear communication about the benefits, and a bit of luck to navigate unexpected external events. Key Takeaways: * **Digital Transformation is Essential:** The pharmaceutical industry must embrace digital transformation, particularly in quality management, to enhance efficiency, convenience, and compliance, driven by increasing data volumes and modern user expectations. * **Cost of Compliance is Rising:** The cost of bringing a new pharmaceutical product to market has significantly increased (from $0.8B to $2.5-$2.6B in 15 years) due to the heightened demand for data, evidence, and regulatory assurance, making digital solutions critical for cost control. * **Substantial Operational Savings:** Implementing an eQMS can lead to significant operational cost reductions, estimated at 20-30% in data management, by streamlining processes, reducing manual effort, and improving data accuracy. * **Overcoming Implementation Challenges:** Companies must address the fear of change, the complexity of validation rules, and the need for robust data integrity and change of custody protocols when transitioning from paper-based or legacy systems. * **Evolution of QA's Role:** The role of quality assurance professionals is shifting from managing paper-based processes to becoming "gatekeepers" in structured electronic systems, and eventually to "cyber analysts" who interpret vast amounts of data to drive insights and make risk-based decisions. * **Platform-Based Harmonization:** Next-generation QMS solutions should be platform-based, offering a harmonized view that integrates core quality processes like document control, training, change control, deviation, investigation, and risk management, rather than operating as disconnected silos. * **Importance of Supplier Collaboration:** With the rise of virtual manufacturing and outsourced activities, eQMS must facilitate seamless and secure collaboration with suppliers and Contract Manufacturing Organizations (CMOs) to manage shared risks and ensure end-to-end quality. * **Choosing the Right eQMS Partner:** Companies should evaluate three types of vendors: traditional ERP systems (often generic, heavy customization), traditional QMS solutions (industry-focused but potentially outdated), and modern cloud solutions that leverage existing platforms (agile, ready-to-use, industry-specific). * **"Ready-to-Use" Solutions for Rapid Deployment:** Modern eQMS vendors are offering "ready-to-use" applications that can be deployed in days, meeting common industry requirements with pre-configured processes and validation documentation, reducing the burden on internal IT and regulatory teams. * **Strategic Implementation Team:** A successful eQMS deployment requires a dedicated team comprising a quality subject matter expert, an executive sponsor (e.g., Head of QA, Operations, or CEO), and strong IT representation to manage technical, process, and cultural aspects. * **Realistic Transition Plan & Change Management:** Companies need a realistic transition plan, understanding their organizational culture, and a robust change management strategy to win the "hearts and minds" of employees, as quality is a culture, not just a system. * **"Rule of Three" Deployment Strategy:** A practical approach for initial deployment suggests focusing on "three major processes in three months" to achieve quick wins and build momentum, with a goal of digitalizing 90% of processes for a mid-sized manufacturing organization within a year. * **Seamless Integration Capabilities:** Modern eQMS must offer robust integration capabilities (e.g., web services, IoT infrastructure) to connect with other enterprise systems like ERP, CRM, and manufacturing sensors, creating a comprehensive data ecosystem. * **Simplicity and User Experience:** Despite regulatory complexities, eQMS should prioritize simplicity and a modern user experience, making it as intuitive as consumer applications to encourage adoption and productivity. **Tools/Resources Mentioned:** * **Dot Compliance:** A SaaS application that provides an eQMS solution for life sciences companies (pharmaceutical, medical device, biotech), focusing on quality, compliance, and regulatory aspects. **Key Concepts:** * **eQMS (Electronic Quality Management System):** A software system designed to manage and automate quality processes and documentation within an organization, particularly critical for regulated industries like pharmaceuticals. * **Digital Transformation:** The process of adopting digital technology to improve an organization's processes, culture, and customer experiences to meet changing business and market requirements. * **Data Integrity:** The assurance that data is accurate, consistent, and reliable throughout its lifecycle, a critical regulatory requirement in life sciences. * **Validation:** The process of establishing documented evidence that a system or process consistently produces a product meeting its predetermined specifications and quality attributes. * **GxP (Good x Practice):** A collection of quality guidelines and regulations (e.g., Good Manufacturing Practice, Good Clinical Practice) that ensure products are safe, effective, and of high quality. * **21 CFR Part 11:** Regulations issued by the FDA that set forth the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. * **Platform-based QMS:** A quality management system built on a robust, extensible technology platform that allows for the integration and harmonization of various quality processes. * **Ready-to-use QMS:** An eQMS solution that comes pre-configured with common functionalities and validation documentation, allowing for rapid deployment with minimal customization. * **Risk-Based Approach:** A strategy for quality management that prioritizes resources and efforts based on the level of risk associated with different processes or activities.