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Spotlight On... Getting Your Quality Management System Right
ACRP - Assoc. of Clinical Research Professionals
/@ACRPDC
Aug 3, 2020
This video provides an in-depth exploration of the critical importance of getting Quality Management Systems (QMS) right, particularly within the dynamic landscape of clinical research. Featuring Glenda Guest, VP of Norwich Clinical Research Associates and an ACRP Fellow, the discussion highlights how QMS and risk management have become paramount, especially in the era of COVID-19, which necessitated significant alterations to standard clinical trial processes. Guest, drawing from her 18 years of experience as a medical device professional, emphasizes that while QMS originated in manufacturing, its applicability to clinical research has been underscored by recent revisions to the International Council for Harmonisation (ICH) E6 guideline. The conversation delves into how the pandemic introduced unprecedented flexibility into previously rigid rules, making robust QMS essential for maintaining quality, protecting subjects, and ensuring the integrity of data in an altered environment. Guest explains that the shift towards risk-based monitoring has placed greater responsibility on clinical sites for quality control, a challenge for many, ranging from small sites to large organizations with dedicated departments. She stresses that effective QMS links all stakeholders—sites, Institutional Review Boards (IRBs), and sponsors—and requires active engagement from regulators who now provide crucial guidance alongside traditional regulations. A significant portion of the discussion focuses on the severe downsides of neglecting proper QMS. As an auditor, Guest frequently observes the consequences of inadequate quality, which manifest as more errors, inappropriate data collection, incorrect subject enrollment, audit observations, corrective actions, and rework, ultimately leading to potential loss of critical data. She differentiates between Quality Control (proactive measures like setting standards and training) and Quality Assurance (retrospective assessment of system effectiveness and quality attainment). The video concludes by reiterating the urgent need for sites to enhance their internal quality control mechanisms, especially as reliance on frequent on-site monitor visits has decreased, making QMS a non-negotiable necessity for safeguarding important studies, including those related to COVID-19. Key Takeaways: * **QMS is Crucial in Dynamic Environments:** The COVID-19 pandemic highlighted the indispensable role of Quality Management Systems and risk management in clinical research, as operational flexibility and altered processes necessitated robust frameworks to maintain quality and data integrity. * **ICH E6 Guideline Reinforces QMS Importance:** Recent revisions to the International Council for Harmonisation (ICH) E6 guideline have brought QMS to the forefront, making it a more recognized and understood concept within the clinical research community. * **Shift to Risk-Based Monitoring Increases Site Responsibility:** The move towards risk-based and remote monitoring models has significantly increased the burden on clinical sites to implement and manage their own quality control measures, a responsibility previously often shared with on-site monitors. * **QMS Encompasses Quality Control and Quality Assurance:** Quality Control involves proactive steps like setting standards, training personnel, and guiding proper job performance, while Quality Assurance is the retrospective evaluation of whether the system worked and if intended quality levels were achieved, prompting necessary changes. * **Downsides of Poor QMS are Significant:** Neglecting QMS can lead to a cascade of negative outcomes, including increased errors, inappropriate data collection, incorrect subject enrollment, adverse audit observations, extensive rework, and ultimately, the potential loss of critical study data. * **QMS Links All Stakeholders:** Effective quality management systems are vital for connecting and coordinating efforts across all levels of clinical research, including sites, Institutional Review Boards (IRBs), sponsors, and regulators, ensuring a unified approach to quality. * **Regulators Provide Guidance in Evolving Landscapes:** In times of rapid change and increased operational flexibility, regulators play an even more critical role by providing necessary guidance in addition to enforcing regulations, helping the industry navigate new challenges while maintaining standards. * **Sites Must Enhance Internal Quality Control:** With less frequent on-site monitoring, clinical sites must proactively develop and implement strong internal quality control processes to prevent major losses, particularly in high-stakes studies like those for COVID-19. * **QMS Originates from Manufacturing but is Highly Applicable to Clinical Research:** The concept of quality management, while originating in manufacturing, is directly transferable and highly applicable to clinical research, emphasizing process control and systematic quality assurance. * **Challenges in QMS Implementation Vary by Site Size:** Both small and large clinical sites face unique challenges in implementing QMS; small sites may struggle with resources, while large sites might have established departments but still need to adapt to new monitoring paradigms. Key Concepts: * **Quality Management System (QMS):** A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. It helps coordinate and direct an organization's activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis. * **Risk Management:** The systematic process of identifying, assessing, and controlling risks that could impact the quality, safety, or integrity of clinical trials. * **ICH E6 Guideline:** The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 (R2) Good Clinical Practice (GCP) guideline provides a unified standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. Revisions have increasingly emphasized quality management and risk-based approaches. * **Risk-Based Monitoring:** A strategy for monitoring clinical trials that focuses monitoring activities on the most important risks to human subjects and data quality, rather than on comprehensive, 100% source data verification. * **Quality Control (QC):** Operational techniques and activities used to fulfill requirements for quality. This includes setting standards, training staff, and guiding them in the proper performance of their jobs. * **Quality Assurance (QA):** A system of activities designed to ensure that quality requirements are met. It involves assessing whether the overall system worked as intended and if the desired level of quality was attained, leading to necessary changes and improvements. * **IRB (Institutional Review Board):** A committee established to review and approve research involving human subjects. Its primary purpose is to ensure the ethical and scientific soundness of research and to protect the rights and welfare of human participants. * **Sponsor:** An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.
Start Your Career With Veeva | WayUp Virtual Info Session
WayUp
/@WayUp
Jul 29, 2020
This video provides an in-depth exploration of Veeva, a prominent software and consulting firm in the life sciences industry, as presented by its Founder and CEO, Peter Gassner, and Anka, a program director for Veeva's consultant development program. The session, hosted by WayUp, primarily serves as an informational event for early-career professionals, offering insights into Veeva's mission, culture, and career opportunities, particularly through its "Generation Veeva" new graduate programs. Gassner establishes the foundational understanding of Veeva's critical role in the life sciences sector, emphasizing its commitment to developing specialized software, consulting services, and data solutions that support the entire lifecycle of medicine and medical product creation and delivery globally. Gassner elaborates on Veeva's core business, which involves serving a diverse range of life sciences entities, from small biotechs focused on specific diseases to large pharmaceutical giants like Pfizer, Novartis, and Amgen. He powerfully conveys the industry's significance by referencing the historical impact of medical advancements, such as the eradication of polio, and its current efforts in developing COVID-19 vaccines and therapies. Veeva's technology is instrumental in helping these companies design, gain approval for, and legally bring medicines to market worldwide. The company, founded in 2007, has grown to 4,000 employees and generates $1.5 billion in revenue, underscoring its substantial influence and footprint within the industry. The discussion consistently highlights Veeva's overarching contribution to improving and extending human life by enabling the vital work of the life sciences sector. The session further delves into specific examples of Veeva's product innovation and its crucial adaptability during the COVID-19 health crisis. Gassner proudly details how Veeva's cloud-based systems for manufacturing process control ensure stringent regulatory compliance and patient safety, particularly for complex processes like biologic production, where errors could have fatal consequences. He also recounts a rapid deployment project in the UK, where Veeva swiftly established collaboration systems for a consortium of companies (including Dyson and Formula 1 teams) to quickly and safely produce thousands of ventilators. Another key innovation discussed is software designed to make patient participation in clinical trials easier, more enjoyable, and faster. The pandemic necessitated rapid adjustments to Veeva's product roadmap, especially to enable remote clinical trial inspections and virtual collaboration, demonstrating the company's agility and responsiveness to evolving industry needs and regulatory landscapes. The mention of Veeva Vault and the company's offering of machine learning services for data science purposes further illustrates its technological breadth. Beyond its products, the video emphasizes Veeva's team-oriented culture and its four core values, listed in order of importance: "Do the Right Thing," "Customer Success," "Employee Success," and "Speed." Gassner stresses that "Do the Right Thing" encompasses ethics, honesty, integrity, and treating others with respect, serving as the paramount guiding principle. He shares personal anecdotes about his own career trajectory and the inspiration behind the "Generation Veeva" program, which aims to integrate young talent into the company and the broader life sciences industry. Anka, as a program director, offers insights into the consultant development program, highlighting the importance of building a strong professional reputation, continuous learning, and contributing actively to the team. The session concludes with valuable career advice centered on focusing on contribution, excelling in one's work, and cultivating strong professional relationships, rather than solely pursuing a predefined "dream job." Key Takeaways: * Veeva's primary mission is to empower the life sciences industry through specialized software, consulting, and data solutions that facilitate the design, approval, and compliant market entry of medicines and medical products globally. * The company serves a broad spectrum of life sciences clients, from small biotech startups to major pharmaceutical corporations like Pfizer, Novartis, and Amgen, reflecting its comprehensive industry reach. * Veeva emphasizes the profound societal impact of the life sciences industry, citing historical successes like polio eradication and current efforts in developing COVID-19 treatments and vaccines as examples of its contribution to human well-being. * Veeva's product portfolio includes critical applications for manufacturing process control, which are essential for ensuring regulatory compliance (e.g., GxP standards) and patient safety in the production of complex medicines like biologics. * The company demonstrated significant agility during the COVID-19 pandemic by rapidly adjusting its product roadmap to support remote operations, such as virtual clinical trial inspections, ensuring business continuity and compliance in a changing environment. * Veeva quickly developed and deployed collaboration systems for emergency initiatives, such as a consortium producing ventilators, highlighting the importance of robust and adaptable technology platforms in crisis management. * Innovations include software designed to streamline and enhance patient participation in clinical trials, making the process more efficient and user-friendly, which is a key area for operational optimization in clinical development. * Veeva operates on four core values: "Do the Right Thing" (ethics, honesty, integrity), "Customer Success," "Employee Success," and "Speed," with "Do the Right Thing" being the most fundamental guiding principle for all decisions. * The company actively invests in nurturing early-career talent through programs like "Generation Veeva," which offers structured pathways in consulting, engineering, and product management roles within the life sciences technology sector. * Career advice from the CEO stresses the importance of focusing on contribution to the team, excelling in one's work, and building strong professional relationships, rather than solely pursuing a fixed "dream job," promoting adaptability and a growth mindset. * Veeva's product strategy involves "running to the complexity" of specific industry areas, developing highly specialized products tailored to unique pharmaceutical workflows and stringent regulatory requirements, rather than generic software. * The company's offerings include Veeva Vault, a prominent platform in the life sciences, and it also provides machine learning services to customers for data science applications, aligning with advanced analytics and AI trends. * A key to Veeva's sustained success is its unwavering commitment to staying close to customers, actively listening to their needs, and consistently delivering measurable value, which is a crucial best practice for any technology firm in a regulated industry. **Tools/Resources Mentioned:** * **Veeva Vault:** A key platform within Veeva's product ecosystem. * **WayUp:** The platform hosting the virtual info session, focused on early-career job and internship opportunities. **Key Concepts:** * **Generation Veeva:** Veeva's new graduate development program designed for early-career professionals in consulting, engineering, and product management. * **Do the Right Thing:** Veeva's paramount core value, emphasizing ethics, honesty, integrity, and respectful treatment of others. * **Customer Success, Employee Success, Speed:** The other three core values of Veeva, listed in order of importance after "Do the Right Thing." * **Clinical Research Associates (CRAs):** Professionals who traditionally inspect clinical trial documentation at research sites, whose work was impacted by COVID-19. * **HIPAA Compliance:** Implied requirement for virtual clinical trial processes to protect patient data. **Examples/Case Studies:** * **Manufacturing Process Control:** Veeva's software helps pharmaceutical companies, particularly those producing biologics, adhere to strict policies and procedures to ensure legal and safe manufacturing, preventing dangerous outcomes. * **COVID-19 Ventilator Consortium:** Veeva rapidly deployed collaboration systems for a consortium of UK companies (including Dyson and Formula 1 teams) to quickly and safely manufacture thousands of ventilators during the pandemic. * **Clinical Trial Patient Participation:** Veeva develops software to make it easier, more enjoyable, and faster for patients to participate in clinical trials. * **Pharmaceutical Sales Reps in Japan:** Veeva's software caters to the very specific business processes, regulations, and workflows involved in introducing new drugs in Japanese hospitals.
Episode 2: Elevate Your Quality Management System
MasterControl
/@MasterControlVideo
Jul 23, 2020
This video explores the critical importance and true cost-benefit of implementing and expanding a robust Quality Management System (QMS) throughout life sciences organizations, particularly into manufacturing. Speakers Brian Curran and Terrance Holbrook emphasize that a QMS is a strategic investment that yields significant returns by mitigating hidden costs associated with paper-based processes, such as human errors, expedited shipping, overtime, and recalls. They advocate for moving beyond traditional QA department-centric QMS to a holistic "culture of quality" that permeates the entire organization, driven by digitization and connected systems. The discussion highlights how digitizing work instructions, training, and data capture eliminates costly human errors, improves efficiency, and enables adaptability, aligning with Industry 4.0 principles. The speakers also touch upon the challenges of siloed information, the "us vs. them" dynamic between quality and manufacturing, and the need for integrated digital tools to streamline processes like CAPA management and ensure audit readiness. Ultimately, a digitized QMS is presented as essential for scalability, speed to market, increased revenue, and achieving a substantial ROI. Key Takeaways: * **QMS as a Strategic Investment:** A comprehensive QMS is not merely a compliance cost but a strategic investment that delivers substantial ROI (often 6-18 months) by reducing hidden costs, improving operational efficiency, and enhancing speed to market and revenue within life sciences. * **Enterprise-Wide Quality Culture:** Effective quality management extends beyond the QA department to encompass the entire organization, especially manufacturing. Digitizing processes across the shop floor is crucial to eliminate paper-based errors, foster a unified "culture of quality," and prevent "us vs. them" dynamics between departments. * **Digitization for Operational Excellence & Compliance:** Transitioning from paper-based systems to digital platforms for work instructions, training, data capture, and CAPA management is essential to reduce human errors, streamline compliance (e.g., GMP requirements), and enable real-time insights necessary for adaptability and Industry 4.0 initiatives. * **Connected Data for AI/ML Readiness:** The ability to leverage advanced technologies like machine learning and artificial intelligence for data mining and intelligent adaptation in manufacturing is contingent upon having connected, non-siloed digital data, which is a core benefit of a digitized QMS. * **Enhanced Scalability and Adaptability:** A digitized QMS is fundamental for organizational scalability and adaptability, allowing companies to respond effectively to market demands, supply chain disruptions, and regulatory changes, which is impossible with rigid, paper-based systems.
SCRS Talks: Connecting Patients, Sites, and Sponsors to Improve Clinical Trials
Veeva Systems Inc
/@VeevaSystems
Jul 23, 2020
This. ai provides. This video explores the pressing challenges faced by patients, research sites, and sponsors in clinical trials, particularly exacerbated by the COVID-19 pandemic. Bree Burks from Veeva Systems highlights the industry's struggle with disparate systems and processes that limit data sharing and collaboration, leading to increased patient burden, financial instability for sites, and inefficiencies in drug development for sponsors. The discussion emphasizes the critical need for a more connected and patient-centric approach, advocating for technology that empowers rather than replaces research sites. Veeva's strategy to build a unified platform for the entire clinical trial ecosystem, including dedicated solutions for sites and patients, is presented as a key opportunity for improvement. Key Takeaways: * **Fragmented Clinical Trial Ecosystem:** The industry suffers from a lack of technological connectivity and data sharing between patients, research sites, and sponsors, leading to significant operational inefficiencies and increased burden across all stakeholders. * **Shift to Patient-Centricity and Site Empowerment:** There's an urgent need to design clinical trials with patient experience in mind and to empower research sites with integrated technology solutions, moving away from the concept of "site-less trials" towards "technology-empowered sites." * **Platform Approach to Technology:** Research sites should strategically evaluate technology partners that offer a unified, integrated platform rather than managing numerous disparate point solutions, which often leads to costly and complex integration challenges. * **Veeva's Expanding Clinical Trial Ecosystem:** Veeva is actively expanding its offerings beyond sponsors and CROs to include purpose-built, seamlessly integrated technology for research sites and patients, aiming to create a comprehensive, connected platform for the entire clinical trial lifecycle. * **Regulatory Compliance as a Core Feature:** Technology solutions for clinical trials must inherently address stringent regulatory requirements, with providers like Veeva explicitly offering 21 CFR Part 11 compliant tools to streamline operations while ensuring adherence. * **Strategic Technology Partnership for Sites:** Sites are advised to seek long-term technology partners that understand their complex needs, align with their vision, and can provide evolving, integrated solutions, rather than focusing solely on current features.
PSC Biotech Corporation Presentation for Bio Cost Savings
Biotechnology Innovation Organization
/@BioOrgBiotech
Jul 21, 2020
This video provides an in-depth exploration of PSC Biotech Corporation's software and service solutions tailored for life science companies, presented in the context of their partnership with the Biotechnology Innovation Organization (BIO). The presentation, led by Thomas, details the company's background, its specific software offerings, and its computer systems validation services, culminating in a discussion of the exclusive benefits available to BIO members. The core purpose is to showcase how PSC Biotech helps companies transition from paper-based or legacy quality management systems to modern, cloud-based, and compliant electronic solutions that provide actionable insights. The presentation begins with a brief history of PSC Biotech, founded in 1996, highlighting its growth to over 1,000 clients worldwide and the addition of specialized divisions, with a particular focus on PSC Software, established in 2009. The impetus for PSC Software was the observed dissatisfaction among companies with existing quality management processes, driving the need for user-friendly, cloud-based software capable of delivering actionable information. This led to the development of three primary software solutions: ACE, ACE Essentials, and AuditUtopia, each designed to address specific needs within the life sciences quality and compliance landscape. The video then delves into each software solution. ACE (Adaptive Compliance Engine) is presented as a single-platform enterprise quality management system, designed to minimize administrative burdens and maximize ROI through productivity gains, all within a 21 CFR Part 11 compliant framework. It offers adaptability to various business processes, enabling real-time tracking and reporting for compliance, quality, and operational activities such as managing CAPAs, deviations, controlled documents, training, and supplier audits. Key differentiators include its unified platform approach, transparent pricing (no separate modules), high configurability, integrated analytics, and intuitive user interface, supported by numerous pre-configured workflows. ACE Essentials is introduced as a streamlined EQMS for startups and small life science companies, offering essential quality processes, pre-loaded SOPs, policies, and a quality manual for immediate compliance, with a simple upgrade path to the full ACE system as companies grow. Lastly, AuditUtopia is detailed as a standalone, real-time inspection management software, crucial for hosting regulatory inspections and client audits by enabling efficient tracking of scribe notes, requests, and related activities, ensuring teams stay organized and responsive. Beyond software, PSC Biotech emphasizes its Computer Systems Validation (CSV) services, leveraging over two decades of consulting experience to provide FDA and EMA compliant, customized solutions. These services cover validation for a wide range of third-party enterprise systems, including ERP, DMS, VMS, and BMS, alongside specialized services for 21 CFR Part 11 compliance, data integrity assessments, remediation, and training. The presentation concludes by outlining the significant discounts and free trial offers extended to BIO and state affiliate members across PSC's software and CSV services, reinforcing their commitment to supporting the life sciences community with compliant and efficient solutions. Key Takeaways: * **Addressing Legacy System Challenges:** PSC Biotech was founded on the premise of solving common industry pain points related to inefficient paper-based or outdated legacy quality management systems, offering modern cloud-based alternatives. * **Comprehensive Enterprise Quality Management (ACE):** The Adaptive Compliance Engine (ACE) serves as a unified, single-platform EQMS that manages a broad spectrum of quality and compliance activities, including CAPAs, deviations, controlled documents, training, and supplier audits, all within a 21 CFR Part 11 compliant environment. * **21 CFR Part 11 Compliance Focus:** A central theme across all PSC Biotech's software and services is adherence to 21 CFR Part 11, ensuring electronic records and signatures are trustworthy and equivalent to paper records, which is critical for regulated life science companies. * **Integrated Analytics for Actionable Insights:** ACE incorporates an integrated analytics and visualization platform, enabling users to extract actionable information from their quality data, supporting data-driven decision-making and continuous improvement. * **Tailored Solutions for Small Businesses (ACE Essentials):** ACE Essentials provides a pre-configured and pre-validated EQMS specifically designed for life science startups and small companies, offering a rapid, compliant solution with pre-written SOPs, policies, and a quality manual to expedite compliance from day one. * **Seamless Scalability:** For small companies starting with ACE Essentials, there is a clear and simple upgrade path to the full ACE system, ensuring the solution can grow with the company's evolving needs without disruption. * **Specialized Inspection Management (AuditUtopia):** AuditUtopia offers a dedicated, real-time inspection management software that streamlines the process of hosting regulatory inspections and client audits, enhancing organizational readiness and responsiveness through real-time updates and configurable dashboards. * **Extensive Computer Systems Validation (CSV) Services:** PSC Biotech provides expert CSV services, ensuring FDA and EMA compliance for various third-party enterprise systems (ERP, DMS, VMS, BMS), which is crucial for maintaining data integrity and regulatory adherence across a company's technology stack. * **Data Integrity and Remediation Expertise:** Beyond validation, their CSV services include data integrity assessments, remediation, and training, highlighting a holistic approach to ensuring the reliability and accuracy of electronic data in regulated environments. * **Flexible and Configurable Software:** ACE is designed to be highly adaptive and user-configurable, allowing the software to conform to a company's specific business processes rather than forcing the company to adapt to the software. * **Transparent Pricing Model:** PSC Software employs a transparent pricing model for ACE, where all pre-configured workflows are included, and there are no separate modules to purchase, simplifying budgeting and maximizing perceived value. * **Strategic Industry Partnerships:** The partnership with BIO, offering significant discounts on software and services, demonstrates PSC Biotech's commitment to supporting the broader biotechnology ecosystem and making compliant solutions more accessible to its members. **Tools/Resources Mentioned:** * **ACE (Adaptive Compliance Engine):** Enterprise electronic quality management system. * **ACE Essentials:** Electronic quality management system for small life science companies and startups. * **AuditUtopia:** Stand-alone real-time inspection management software. * **BIO (Biotechnology Innovation Organization):** Industry organization partnered with PSC Biotech. **Key Concepts:** * **Electronic Quality Management System (EQMS):** Software solutions designed to manage and automate quality processes and documentation in a regulated environment. * **Computer Systems Validation (CSV):** The process of ensuring that computer systems used in regulated industries perform as intended and meet regulatory requirements (e.g., FDA, EMA). * **21 CFR Part 11:** Regulations issued by the FDA governing electronic records and electronic signatures, ensuring their trustworthiness, reliability, and equivalence to paper records. * **CAPA (Corrective and Preventive Actions):** A system for identifying, documenting, and addressing non-conformances and preventing their recurrence. * **Deviations:** Departures from approved instructions or established standards. * **Change Control:** A formal process used to manage modifications to documents, procedures, or systems in a regulated environment. * **Controlled Documents:** Documents (e.g., SOPs, policies, specifications) that are managed under a formal control system to ensure accuracy, approval, and distribution. * **Learning Management System (LMS):** A software application for the administration, documentation, tracking, reporting, automation, and delivery of educational courses or training programs. * **Data Integrity:** The assurance that data is accurate, consistent, and reliable throughout its lifecycle, critical for regulatory compliance.
Easy Product Configuration Demo | ComplianceQuest Quality & Safety Management System
ComplianceQuest
/@ComplianceQuest
Jul 15, 2020
This video provides an in-depth demonstration of the easy configuration and customization capabilities within the ComplianceQuest Quality & Safety Management System, specifically showcasing features from its acquired entity, LifeGuard Solutions. The main purpose of the demo, led by Gavin Bevel, Director of Solution Engineering and Product Development, is to illustrate how system administrators can quickly and easily modify dashboards and forms without requiring complex coding or extensive technical expertise. The underlying platform is built natively on Salesforce, which allows for a unified Quality, Health, Safety, and Environment (QHSE) solution. The demonstration progresses through two primary use cases. First, it addresses the common request of adding a new chart or report to an existing dashboard. Bevel walks through the process of editing a dashboard, adding a new component, selecting a pre-existing report (e.g., "offense by month"), and then customizing its visualization, such as changing it to a line graph. The system features a drag-and-drop environment, enabling administrators to intuitively reposition the new report anywhere on the dashboard screen. The second use case focuses on adding a new field to an existing form or application, using an "audit application" as an example. Bevel shows how to create a new field, selecting a "textarea" type, naming it "notes," and quickly assigning permissions before saving it. He then demonstrates how to integrate this new field into the form's layout, again using a drag-and-drop interface to place it in the desired location, such as above "frequency" or within "contact information." Throughout the video, the speaker emphasizes the speed and simplicity of these configuration tasks, highlighting that both processes—adding a report to a dashboard and adding a field to a form—can be completed in less than two minutes. This rapid customization capability is presented as a significant advantage for organizations needing agile adjustments to their quality and safety management systems. The approach underscores a user-centric design where system administrators can maintain and evolve the solution to meet changing business needs and regulatory requirements without significant IT overhead, thereby streamlining operations and enhancing compliance. Key Takeaways: * **Agile System Configuration:** The ComplianceQuest platform, incorporating LifeGuard Solutions, offers robust, user-friendly configuration tools that allow system administrators to quickly customize dashboards and forms without coding, fostering agility in responding to operational and regulatory changes. * **Salesforce Native Platform:** The system is built natively on the Salesforce platform, indicating a foundation of scalability, security, and integration capabilities that are common in enterprise-level solutions and potentially beneficial for organizations already leveraging Salesforce ecosystems. * **Dashboard Customization for Insights:** Administrators can easily add new reports and charts to dashboards, enabling quick visualization of key performance indicators (KPIs) and operational data, such as "events by month," which is crucial for data-driven decision-making in quality and safety management. * **Intuitive Drag-and-Drop Interface:** Both dashboard and form customizations are facilitated by a drag-and-drop interface, significantly reducing the learning curve and time required for modifications, making the system accessible to non-developer administrators. * **Rapid Form Field Addition:** The process for adding new fields to application forms, such as a "notes" textarea field to an "audit application," is streamlined, allowing for quick adaptation of data capture requirements. This includes selecting field types, naming, and assigning permissions. * **Permission-Based Field Visibility:** When adding new fields, administrators can assign specific permissions, controlling who can see and interact with the field, ensuring data security and role-based access within the system. * **Operational Efficiency and Compliance:** The ease of configuration directly contributes to operational efficiency by allowing organizations to quickly adapt their QMS/EHS to evolving needs, which is vital for maintaining regulatory compliance in dynamic environments. * **Unified QHSE Solution:** ComplianceQuest offers a unified Quality, Health, Safety, and Environment solution, suggesting a comprehensive approach to managing various aspects of operational compliance and risk management within a single platform. * **AI Augmentation for Risk Mitigation:** While not explicitly demonstrated in the video, the platform's description mentions being "augmented by AI to mitigate risks," indicating a strategic integration of artificial intelligence to enhance compliance operations and decision-making. * **Empowering System Administrators:** The demo highlights how system administrators are empowered to make significant configuration changes independently, reducing reliance on development teams and accelerating the deployment of system enhancements. Tools/Resources Mentioned: * ComplianceQuest Quality & Safety Management System * LifeGuard Solutions (acquired by ComplianceQuest) * Salesforce Platform (underlying technology) Key Concepts: * **EQMS (Enterprise Quality Management System):** A system designed to manage and automate quality processes across an enterprise, ensuring compliance with industry standards and regulations. * **EHS (Environmental, Health, and Safety) Solution:** A system focused on managing an organization's environmental impact, employee health, and workplace safety. * **Product Configuration:** The process of customizing a software product to meet specific user or organizational requirements, often without altering the core code. * **Dashboard Customization:** The ability to modify the layout, content, and visualization of data dashboards to provide relevant insights to different user roles. * **Form Field Customization:** The process of adding, removing, or modifying data entry fields on digital forms to capture necessary information for specific applications or processes. * **Drag-and-Drop Interface:** A graphical user interface feature that allows users to select and move objects (like reports or fields) on a screen using a mouse or touch input, simplifying interaction and configuration. * **System Administrator Role:** An individual responsible for the configuration, maintenance, and user management of a software system. Examples/Case Studies: * **Dashboard Report Addition:** The demonstration included adding an "events by month" report, visualized as a line graph, to an existing dashboard to provide quick insights into operational trends. * **Form Field Creation:** A "notes" textarea field was added to an "audit application" form, illustrating how new data capture requirements can be rapidly implemented within the system.
Veeva Systems (VEEV) TOO EXPENSIVE? Painless Stock Analysis - Investfluent
Investfluent
/@investfluent4143
Jul 13, 2020
This video, although framed as a stock analysis, provides a detailed overview of Veeva Systems' cloud-based solutions for the life sciences industry. It systematically breaks down Veeva's core offerings: the Commercial Cloud, Data Cloud, and Vault. The speaker explains how these platforms address critical industry needs, from enhancing commercial engagement with healthcare professionals and managing marketing campaigns to streamlining research and development processes, all while maintaining stringent regulatory compliance. The video emphasizes Veeva's role in modernizing the life sciences sector by creating a collaborative clinical ecosystem. Key Takeaways: * **Comprehensive Veeva Ecosystem:** Veeva Systems offers a holistic suite of cloud solutions—Commercial Cloud, Data Cloud, and Vault—designed to support various facets of the life sciences industry, from commercial operations to R&D and regulatory compliance. * **Veeva Commercial Cloud Capabilities:** This platform enables multichannel Customer Relationship Management (CRM), handling complex tasks such as prescription drug sample management, medical inquiries from physicians, and electronic signature capture across diverse platforms (e.g., iPads, Email, WhatsApp), with a strong emphasis on regulatory adherence. * **Veeva Data Cloud for Insights & Compliance:** The Data Cloud focuses on providing accurate customer reference data to enhance marketing efforts and ensures compliance with global privacy laws, acting as an extension of existing data solutions. * **Veeva Vault's End-to-End Management:** Veeva Vault is presented as a crucial, all-in-one cloud-based suite for managing the entire product lifecycle, encompassing clinical data, clinical operations (including Trial Master File), quality, safety, medical, and commercial aspects, ensuring continuous performance and regulatory compliance. * **Industry Adoption and Modernization:** Veeva CRM has a significant market presence, with 81% of new drugs approved having been launched using it, underscoring Veeva's role in bringing the life sciences industry into a future characterized by collaborative, cloud-based solutions.
Top 10 SaaS Providers to Consider Today
Enterprise Management 360
/@enterprisemanagement360
Jul 7, 2020
This video provides an overview of the top ten Software-as-a-Service (SaaS) providers currently making significant impacts in a rapidly growing and competitive market. The presenter, Max Curtin, systematically counts down from number ten to number one, detailing the core offerings and unique value propositions of each selected company. The video aims to guide businesses through the crowded SaaS landscape by highlighting solutions that stand out for their innovation, market penetration, and comprehensive capabilities across various enterprise functions. The discussion covers a broad spectrum of SaaS applications, ranging from data management and communication platforms to enterprise resource planning (ERP) and customer relationship management (CRM) systems. Each featured provider is presented with a brief description of its primary service, key features, and notable achievements or customer base. The progression of the list illustrates the diverse ways SaaS is transforming business operations, from foundational data services and internal collaboration to external customer engagement and financial processing. Specific examples include Splunk for data-as-a-service, Veeva Systems for life sciences-specific cloud solutions, Twilio for cloud communications, Atlassian for team collaboration, and Square for financial payment processing. The list continues with Workday for integrated finance and HR, ServiceNow for digital workflow transformation, Zoom for video communications, Slack for business collaboration, and finally, Salesforce as a leading integrated CRM platform. The video emphasizes how these platforms enable businesses to achieve greater efficiency, agility, and deeper insights into their operations and customer interactions, often by replacing manual processes with modern digital workflows. The speaker's approach is informative and direct, focusing on the functional benefits and market position of each SaaS offering. While not delving into deep technical specifics, the video effectively communicates the strategic importance of each platform in today's digital enterprise. It underscores the trend towards specialized, cloud-based solutions that can be customized and integrated to meet the evolving demands of various industries, including those with stringent regulatory requirements. Key Takeaways: * **Veeva Systems' Dominance in Life Sciences:** Veeva Systems is highlighted as a prominent cloud solutions provider specifically tailored for the life sciences space, offering essential data, software, and services to support critical business functions like CRM and Master Data Management (MDM). This underscores its specialized role in an industry with unique regulatory and operational requirements. * **Strategic Importance of Data as a Service:** Splunk is recognized as a state-of-the-art solution for data-as-a-service, enabling businesses to extract value from big data through features like multi-site clustering and load balancing. Its open development platform allows for customization, emphasizing the need for flexible and powerful data analytics capabilities. * **CRM as a Centralized Business Hub:** Salesforce is positioned as the number one integrated CRM platform, providing all business departments with a single, shared view of every customer. This highlights the critical role of CRM in tracking customer activity, fostering collaboration, and enhancing customer engagement across the enterprise. * **Digital Transformation through Workflow Automation:** ServiceNow's mission is to lead businesses towards smarter workflows by transforming manual processes into modern digital ones. This emphasizes the growing relevance of end-to-end digital transformation solutions in improving operational efficiency and agility. * **Integrated Enterprise Resource Planning (ERP):** Workday is noted for its cloud ERP system that seamlessly combines finance, HR, and planning functionalities. This integrated approach allows companies to gain deep insights into business performance and adapt quickly to change, crucial for large organizations like Siemens and Adobe. * **Cloud Communications for Customer Engagement:** Twilio, a leading cloud communications platform, offers powerful APIs for developers to engage customers across multiple channels including SMS, voice, video, WhatsApp, and email. This showcases the importance of multi-channel communication strategies for customer interaction and support. * **Collaboration Tools for Team Potential:** Atlassian, with products like JIRA and Trello, and Slack, known for changing the landscape of business collaboration, are presented as essential tools for unleashing team potential. They simplify communication, file sharing, and project management, serving as popular alternatives to traditional email. * **SaaS Market Growth and Competition:** The video frames SaaS as one of the fastest-growing and most competitive industries, indicating a constant need for businesses to evaluate and adopt solutions that offer distinct advantages and stand out from a multitude of offerings. * **Customization and Open Platforms:** Several providers, such as Splunk, are noted for their open development platforms, allowing businesses to customize solutions to their specific needs. This flexibility is a key advantage of modern SaaS offerings, enabling tailored implementations. * **Diverse SaaS Applications:** The range of providers, from payment processing (Square) to video conferencing (Zoom), illustrates the pervasive nature of SaaS across virtually all business functions, demonstrating how cloud-based services underpin various operational aspects. Tools/Resources Mentioned: * Splunk (Data as a Service) * Veeva Systems (Cloud solutions for life sciences, CRM, MDM) * Twilio (Cloud communications platform) * JIRA (Project management/collaboration) * Trello (Project management/collaboration) * Square (Credit card processing/payment solutions) * Workday (Cloud ERP for finance, HR, planning) * ServiceNow (Digital workflow transformation) * Zoom (Video communications) * Slack (Business collaboration) * Salesforce (Integrated CRM platform) Key Concepts: * **Software-as-a-Service (SaaS):** A software distribution model in which a third-party provider hosts applications and makes them available to customers over the Internet. * **Data as a Service (DaaS):** A cloud strategy used to facilitate the provision of data on demand to users from a centralized cloud resource. * **Cloud Communications Platform as a Service (CPaaS):** A cloud-based platform that allows developers to add real-time communication features (voice, video, messaging) to their own applications without building backend infrastructure. * **Customer Relationship Management (CRM):** A technology for managing all your company's relationships and interactions with customers and potential customers. * **Master Data Management (MDM):** A method used to define and manage the critical non-transactional data of an organization to provide a single point of reference. * **Enterprise Resource Planning (ERP):** A system that integrates all facets of an operation, including product planning, development, manufacturing, sales, and marketing. * **Digital Transformation:** The adoption of digital technology to improve an organization's processes, culture, and customer experiences to meet changing business and market requirements. Examples/Case Studies: * **Twilio:** Serves industry disruptors such as Airbnb and Netflix for customer engagement across numerous communication channels. * **Workday:** Trusted by well-known businesses including Siemens and Adobe for its integrated cloud ERP system.
Preparing for Your Oracle, Medidata, and Veeva CTMS Migration Project
Perficient
/@perficient
Jun 25, 2020
This webinar provides an in-depth exploration of preparing for a Clinical Trial Management System (CTMS) migration project, focusing on strategies, considerations, and technical approaches for moving data between systems like Oracle Siebel CTMS, Medidata Rave CTMS, and Veeva Vault CTMS. Presented by Bunim Singh, Director of Clinical Operations Solution Practice at Perficient Life Sciences, the session aims to equip organizations with a framework for analyzing their own CTMS migration needs, whether driven by mergers and acquisitions (CTMS consolidation) or a desire to switch vendors. The discussion covers critical questions such as whether to migrate, what data to migrate, how to execute the migration, and the optimal timing for such projects, emphasizing both business and technical perspectives. The presentation systematically breaks down the decision-making process for CTMS migration, starting with a cost-benefit analysis. It highlights the advantages of migration, including enabling comprehensive reporting across all studies, providing a complete live picture of studies in one system, streamlining operations by having a single set of business processes, and reducing IT support and maintenance costs by decommissioning legacy systems. Conversely, the speaker addresses potential risks such as loss of functionality or data in the new system, lag time between migration and user access, and data disconnects if users operate in both old and new systems concurrently. The video then delves into scoping, advising a two-tiered approach: first, identifying which studies (e.g., long-duration active studies) are good candidates for migration, and second, determining which specific data types or records within those studies are essential to transfer, considering business needs and target system capabilities. A significant portion of the webinar is dedicated to the "how" of migration, exploring various tools and technical approaches. It discusses manual data entry as a potentially cost-effective method for low-volume data, contrasting it with automated options utilizing embedded system tools (like Oracle Siebel's Enterprise Integration Manager or CSV/XML imports for Veeva Vault and Medidata), existing ETL tools (e.g., Informatica, SSIS), or custom-built migration routines. The speaker illustrates three common technical architectures: migrating from an in-house CTMS to another in-house solution (typically database-to-database), migrating from an in-house CTMS to a standard cloud CTMS (requiring data formatting to vendor-prescribed import standards), and migrating to a customized cloud CTMS solution, which can involve building reusable migration solutions for ongoing data transfers like CRO feeds. Finally, timing considerations are discussed, weighing "big bang" deployments against phased, study-by-study rollouts, and emphasizing alignment with training and legacy system decommissioning strategies. Key Takeaways: * **Purpose-Driven Migration:** The primary driver for any CTMS migration should be clearly defined business benefits, such as enabling comprehensive reporting, consolidating operations into a single system, or reducing IT support costs by decommissioning legacy applications. * **Weighing Benefits Against Risks:** Organizations must carefully assess the value of migration benefits against potential risks, including loss of functionality or data, operational lag time post-migration, and data inconsistencies if users access both legacy and new systems. * **Strategic Study Scoping:** When deciding which studies to migrate, prioritize long-duration active studies that will run significantly past the new system's go-live date. Short-term studies or those ending soon may be better left in the legacy system, while new studies can start directly in the new CTMS. * **Data Type Scoping:** Define the scope of data types by identifying what information has a clear target in the new system and what is critical for business needs (e.g., reporting, current operations). Consider if certain data can remain in a legacy system or be archived elsewhere if not essential for the new CTMS. * **Inevitable Data Cleansing and Standardization:** Data migration almost always requires a significant data cleansing effort to transform or translate legacy data into the new system's defined standards (e.g., address formats, list of values). This effort must be factored into project timelines and costs. * **Managing Multiple Data Sources:** The number and variety of legacy data sources (e.g., multiple CTMS, spreadsheets, custom trackers) can dramatically increase migration complexity and effort. Consider a data consolidation effort to combine data into a single format before building migration routines. * **Manual vs. Automated Migration:** For low volumes of data, manual data entry can sometimes be a more cost-effective option than developing and validating complex automated migration routines, especially if the migration is a one-time event. * **Leveraging Existing Tools:** Utilize embedded system tools (e.g., Oracle Siebel EIM, Veeva Vault CSV imports, Medidata XML imports) or existing ETL tools (e.g., Informatica, SSIS) for automated migrations, which can significantly reduce custom development. * **Adherence to Cloud Vendor Formats:** When migrating to standard cloud CTMS solutions (like Veeva Vault or Medidata), data must be formatted precisely to the vendor's prescribed import specifications, as these are typically standardized and not easily customizable. * **Reusable Migration Solutions:** For organizations with ongoing data transfer needs (e.g., CRO feeds, M&A integrations), building a customized cloud CTMS solution with a reusable migration framework can provide significant long-term cost and effort savings. * **Validation is Key:** Validation efforts constitute a substantial portion of the cost and effort for automated data migration projects, ensuring data integrity and regulatory compliance. * **Strategic Timing and Rollout:** The timing of data migration (e.g., "big bang" vs. phased approach) must align with user training schedules and the legacy system decommissioning strategy to minimize operational disruption and maximize user adoption. * **Regulatory Compliance:** All CTMS implementations and data migrations must adhere to industry and regulatory standards and guidelines, such as those from the FDA and EMA, ensuring data integrity and auditability. **Tools/Resources Mentioned:** * **CTMS Platforms:** Oracle Siebel CTMS, Medidata Rave CTMS, Veeva Vault CTMS * **ETL Tools:** Informatica, SSIS * **Embedded Migration Tools:** Oracle Siebel Enterprise Integration Manager (EIM), CSV import formats (for Veeva Vault CTMS), XML import formats (for Medidata Rave CTMS) * **Technology & Platform Vendors:** AWS, Microsoft, Adobe (Perficient's strategic partners) **Key Concepts:** * **CTMS (Clinical Trial Management System):** A software system used to manage and track various aspects of clinical trials, including study planning, site management, patient enrollment, and regulatory compliance. * **Data Migration:** The process of transferring data from one system (legacy) to another (new) due to system upgrades, consolidation, or vendor changes. * **ETL (Extract, Transform, Load):** A three-phase data integration process used to extract data from a source system, transform it into a format suitable for the target system, and load it into the target system. * **Data Cleansing:** The process of detecting and correcting (or removing) corrupt or inaccurate records from a record set, table, or database. * **Data Consolidation:** The process of combining data from multiple sources into a single, unified data store. * **Big Bang Migration:** A migration strategy where all selected data is moved from the legacy system to the new system simultaneously. * **Phased Migration:** A migration strategy where data is moved in stages, often study-by-study or by user group, allowing for incremental rollout and issue resolution. * **Validation:** The process of ensuring that a system or data migration process meets specified requirements and is fit for its intended use, particularly critical in regulated environments like life sciences. **Examples/Case Studies:** * **Growing CRO:** A scenario where a growing Contract Research Organization with limited resources might choose to launch a new CTMS for planned studies rather than migrating existing data, especially if current studies are short-term. * **Oncology Company:** An example of an oncology company managing long-term trials with significant legacy data, where the decision to migrate is complex, especially if a data warehouse already provides consolidated reporting. * **Manual Data Entry Cost Savings:** A historical case where an organization hired temporary data entry personnel to manually key in thousands of contacts, saving money compared to building complex automated migration routines for a one-time transfer. * **Reusable Custom Cloud Solution:** A large global pharma company deployed a customized cloud CTMS solution with a reusable migration framework, which was used for an initial one-time CTMS migration and subsequently for ongoing daily CRO data feeds, demonstrating significant cost and effort savings.
Webinar | How a pharmaceutical company managed their content migration to Veeva Vault successfully
migration-center
/@migration-center
Jun 23, 2020
This video directly addresses content migration to Veeva Vault, a leading regulated enterprise content management (ECM) platform within the life sciences industry.ai specializes in the pharmaceutical and life sciences industries, offers Veeva CRM consulting (part of the broader Veeva ecosystem), and focuses on optimizing operations while maintaining regulatory compliance. This webinar details how Vertex Pharmaceuticals, a biopharmaceutical company, successfully managed a complex content migration project to Veeva Vault RIM. The discussion highlights the transition from traditional, isolated EDMS and registration systems to an integrated, end-to-end regulatory information management platform. Speakers from Veeva and FME (the migration partner) outline the project's approach, timeline, scope, and the significant challenges encountered, such as complicated data mapping, managing two distinct source systems, handling corrupted data, and ensuring rigorous validation in a highly regulated environment. The webinar concludes with practical solutions implemented and crucial lessons learned for future regulated content migration initiatives. Key Takeaways: * **Strategic Shift to Integrated RIM:** The project exemplifies a common industry trend where pharmaceutical companies move from disparate legacy systems to unified, cloud-based platforms like Veeva Vault for comprehensive Regulatory Information Management (RIM), integrating content and registration data for end-to-end visibility and compliance. * **Complexity of Regulated Content Migration:** Migrating content in the highly regulated life sciences sector is inherently complex, requiring specialized tools and expertise to address challenges such as intricate data mapping (often due to years of legacy system evolution), diverse source data types, and stringent validation requirements to ensure compliance. * **Importance of Specialized Migration Tools and Expertise:** The success of such projects relies heavily on purpose-built migration tools and experienced consultants capable of handling sophisticated data extraction, complex transformation rules (e.g., keyword-based reclassification), and robust validation reporting for regulated platforms. * **Phased Approach for Multi-Source Migrations:** A key strategy for integrating data from multiple source systems (e.g., EDMS and a separate registration system) is to load foundational objects (like registration data) first, establishing necessary metadata in the target system before migrating associated documents. * **Critical Project Management & Partnership:** Effective execution within tight timelines (e.g., 8 months for design, implementation, and migration) necessitates a strong collaborative partnership between the client, the platform vendor (Veeva), and the migration specialist, emphasizing clear communication and proactive issue resolution. * **Lessons Learned for Optimization:** Future migration projects can be optimized by ensuring configuration lock *before* mapping begins, performing document and object field mapping concurrently, planning thoroughly for renditions, deferring post-validation configuration changes, and allocating sufficient buffer time between production load and business go-live for comprehensive verification and unexpected issues. * **Data Transformation as an Opportunity:** Beyond simple migration, the project involved reclassifying content under a more granular and updated document model, demonstrating that migration can be an opportunity for business process improvement and data governance enhancement.
eTMF Session- Part 01 Conducted by CLINIASSURE- A Clinical Research Training and Consulting LLP
CLINIASSURE LLP
/@cliniassurellp671
Jun 19, 2020
This video provides an in-depth exploration of the Electronic Trial Master File (eTMF), focusing on its foundational concepts, regulatory importance, and practical implementation within clinical research. The session, led by Tranjeet from CLINIASSURE LLP, begins by establishing the critical role of clinical research in drug development, emphasizing patient safety and efficacy. It then systematically breaks down the components of eTMF, starting with the basics of clinical trials, delving into regulatory guidelines like ICH GCP E6, and differentiating between clinical data management and clinical document management. The speaker's approach is highly interactive, frequently pausing to engage participants and clarify complex terminology, ensuring a solid understanding of the subject matter for aspiring clinical research professionals. The presentation progresses to detail the "ocean" of eTMF, highlighting its vastness and continuous learning curve. A significant portion is dedicated to "Record Information Management" (RIM), explaining its organizational function in managing information throughout its lifecycle, from creation to disposition. The core definition of TMF as a collection of essential documents that facilitate trial conduct and ensure data integrity and GCP compliance is thoroughly discussed. The session meticulously covers the classification and importance of essential documents, referencing ICH GCP E6 R2, and categorizing them into pre-trial, during-trial, and post-trial phases. The speaker also introduces the Drug Information Association (DIA) and its crucial role in fostering innovation and standardizing processes, specifically highlighting the DIA Reference Model for eTMF implementation. The latter part of the video focuses on the practical benefits and tools associated with eTMF. It articulates why eTMF is indispensable in modern clinical trials, citing advantages such as real-time tracking, enhanced search capabilities, reduced trial timelines, improved collaboration, and increased compliance. The speaker demonstrates how the DIA Reference Model provides a structured framework for classifying and tracking documents digitally, using examples like audit certificates and bioanalytical reports with unique artifact IDs. Finally, the session concludes by listing various industry-leading eTMF software and database tools, such as Veeva Vault, Wingspan, Montrium, and MasterControl, and the pharmaceutical companies that utilize them, underscoring the widespread adoption and necessity of electronic systems in managing clinical trial documentation. Key Takeaways: * **Clinical Research Fundamentals:** Clinical trials are paramount for drug development, focusing on safety and efficacy. They involve distinct phases (micro-dosing, Phase 1-3, post-marketing surveillance) and a network of stakeholders including sponsors, subjects, ethics committees, regulatory bodies, and investigators. * **Regulatory Compliance is Core:** All clinical trials must adhere to stringent laws and guidelines from regulatory authorities like the US FDA, MHRA, CDSCO, and TGA. These bodies ensure patient safety and well-being, approving trials based on submitted data and protocols. * **ICH GCP E6 as the Standard:** The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) E6 guideline is fundamental. The speaker emphasizes the full form and highlights the E6 Revision 2 (R2) amendments, which address updates in essential document responsibilities and source document maintenance. * **Distinction Between Data and Document Management:** Clinical Data Management (CDM) involves playing with raw patient data collected from sites and analyzing it in databases. Clinical Document Management (CDM), also known as Record Information Management (RIM) or eTMF, focuses on managing the physical or electronic documents created from this data, such as CRFs and source data. * **Source Data is Foundational:** Source data, defined by GCP as any information in original records and certified copies of clinical findings, observations, and activities, is critical. It forms the basis for CRFs and eCRFs, and its verification (Source Data Verification - SDV) is essential for data integrity. * **eTMF Definition and Purpose:** The Trial Master File (TMF) is a comprehensive collection of essential documents that facilitates the conduct and management of clinical trials. eTMF digitizes this process, allowing for efficient evaluation of trial conduct, data quality, and compliance with GCP. * **Essential Documents are Non-Negotiable:** Essential documents are the minimum required documents (e.g., protocol, investigator brochure, informed consent form) that individually and collectively permit the evaluation of a trial's conduct and the quality of its data. Without them, a clinical trial cannot effectively run or be audited. * **DIA Reference Model for Standardization:** The Drug Information Association (DIA) provides a crucial reference model for eTMF implementation. This model offers a standardized, hierarchical structure for classifying, identifying, storing, and tracking clinical trial documents, ensuring consistency and ease of retrieval across organizations. * **Structured Document Management:** The DIA Reference Model uses a matrix tool with unique artifact IDs (e.g., 2.3.2 for a bioanalytical report) to categorize documents by zone, section, and artifact. This systematic approach is vital for efficient tracking, retrieval, and audit readiness in eTMF systems. * **Benefits of eTMF Adoption:** Implementing eTMF offers significant advantages over paper-based systems, including real-time document tracking and viewing, easier search and retrieval, shortened clinical trial timelines, improved collaboration among stakeholders, increased SOP compliance, better visibility into key trial metrics, cost savings, and enhanced audit and inspection readiness. * **Industry-Leading eTMF Tools:** Various software and database tools are available for eTMF management, such as Veeva Vault, Wingspan, Montrium, MasterControl, and Flex. These are utilized by major pharmaceutical and life sciences companies like Novartis, AstraZeneca, Bayer, and IQVIA to digitize and streamline their clinical documentation processes. * **Continuous Learning in eTMF:** The speaker emphasizes that eTMF is a vast and continuously evolving field, akin to an "ocean." Professionals must commit to ongoing learning to stay updated with new regulations, technologies, and best practices in clinical document management. **Tools/Resources Mentioned:** * **Veeva Vault:** An eTMF software/database tool. * **Wingspan:** An eTMF software/database tool. * **Montrium:** An eTMF software/database tool. * **MasterControl:** An eTMF software/database tool. * **Flex:** An eTMF software/database tool. * **DIA Reference Model:** A standardized matrix tool for TMF document classification and management. * **ICH GCP E6 (R2):** International guideline for Good Clinical Practice. **Key Concepts:** * **eTMF (Electronic Trial Master File):** A digital system for managing all essential documents related to a clinical trial, ensuring compliance, data integrity, and efficient operations. * **RIM (Record Information Management):** An organizational function dedicated to managing information throughout its lifecycle, including identifying, classifying, storing, securing, retrieving, tracking, and disposing of records. * **ICH GCP (International Council for Harmonisation Good Clinical Practice):** An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. * **Essential Documents:** Documents that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced, crucial for demonstrating GCP compliance. * **Source Data:** Any information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial. * **DIA (Drug Information Association):** A global organization that fosters innovation and provides a neutral environment for exchanging vital information and discussions related to healthcare products, technologies, and services. * **DIA Reference Model:** A standardized, hierarchical framework developed by DIA to provide a common structure for organizing and managing TMF documents, facilitating consistency and interoperability. **Examples/Case Studies:** * **Source Data Verification (SDV):** The speaker explains how source data is used to verify information entered into paper CRFs and subsequently into electronic CRFs (eCRFs), highlighting its importance in ensuring data accuracy and integrity. * **Document Classification Example:** The DIA Reference Model is illustrated with examples like "Audit Certificates" and "Bioanalytical Reports," showing how each document is identified (e.g., "Trial Management Zone"), classified (e.g., "Trial Oversight" or "Reports"), and assigned a unique artifact ID (e.g., 2.3.2) for systematic storage and retrieval. * **Global Trial Document Sharing:** The speaker uses an example of a trial running in India, USA, and Germany to demonstrate how eTMF significantly reduces the time and cost associated with sharing documents compared to physical courier or fax.
WAYS Webinar: Ad Promo Submissions: Preparing for the eCTD Mandate
WAYS Pharmaceutical Services
/@wayspharmaceuticalservices8074
Jun 17, 2020
This webinar provides an in-depth exploration of the FDA's eCTD mandate for advertising and promotional (Ad Promo) material submissions, focusing on the transition period leading up to the June 24, 2021, effective date. Presented by Allison Steffen from WAYS Pharmaceutical Services, the session aims to equip life sciences teams with a practical understanding of the final guidance released by the FDA in June 2019. It addresses common challenges and ambiguities, offering a crash course on how to translate the extensive guidance into the required electronic Common Technical Document (eCTD) submission format. The presentation begins by outlining the historical context of the industry's shift from paper to electronic submissions, driven by the FDA Safety and Innovation Act (FDASIA) of 2012. It then delves into the critical distinction between mandatory and non-mandatory eCTD submission types. Mandatory submissions primarily include final samples of promotional materials submitted via Form FDA 2253 upon first distribution, and pre-submissions for products granted accelerated approval (Subpart H or E). Non-mandatory submissions encompass general correspondence and voluntary draft material reviews, though the webinar strongly encourages adopting eCTD for these for efficiency. A significant portion of the webinar is dedicated to the practical aspects of eCTD compilation, offering detailed tips and highlighting common pitfalls. Steffen meticulously walks through the structure of Module 1.15, where most Ad Promo materials reside, explaining the required metadata and the specific placement of various documents like the 2253 form, product labeling, clean promotional materials, and annotated versions with supporting references. The session also differentiates between requirements for CDER and CBER products, particularly concerning the 2253 form and draft material submissions. Special attention is given to the rigorous requirements for accelerated approval products, which necessitate pre-review and highly detailed annotated materials and references to guide FDA reviewers. The webinar concludes with actionable advice for the transition period, urging companies to strategize early, train staff, and convert existing applications to the latest eCTD Module 1 version. Key Takeaways: * **eCTD Mandate for Ad Promo:** The FDA's final guidance on electronic Ad Promo submissions, released in June 2019, established a 24-month transition period, making eCTD format mandatory for certain submission types by June 24, 2021. * **Mandatory Submission Types:** Final samples of promotional materials submitted under Form FDA 2253 (upon first distribution) and pre-submissions for products under accelerated approval (Subpart H or E) are mandatory in eCTD format. * **Non-Mandatory but Recommended:** General correspondence and voluntary draft material submissions are not mandatory in eCTD but adopting the format is highly encouraged for streamlining processes and proactive engagement with the agency. * **Module 1.15 is Key:** Approximately 90% of Ad Promo submission content, including cover letters/correspondence and promotional materials, will reside in Module 1.15, with specific subsections for various interaction types and material categories. * **US Module 1 Backbone Version 3.3:** All eCTD Ad Promo submissions must utilize version 3.3 of the US Module 1 backbone, which has been in use since 2015 and includes important updates, particularly around Module 1.15. * **No Bundling:** Ad Promo submissions cannot be bundled with other NDA or BLA activities (e.g., CMC amendments). Materials for consumers and healthcare professionals must be submitted separately, as should different types of Ad Promo submissions (e.g., correspondence with 2253). * **Specific Form Requirements:** For 2253 submissions, the form itself is crucial, requiring details like audience type (professional or consumer), material type, dissemination date, and a unique material ID. CDER only requires the 2253 for final samples, while CBER requires it for both final and draft materials. * **Product Labeling:** The current approved product labeling must be submitted with every 2253 sequence, placed in Module 1.14.6, and always marked with the "new" operator, even if cross-referenced. * **Accelerated Approval Products (Subpart H/E):** These products require mandatory pre-review of promotional materials before release. Pre-submissions include draft materials for the first 120 days of marketing (before PDUFA date) and subsequent materials (30 days before intended use). * **Required Annotations for Drafts:** For accelerated approval pre-submissions and voluntary draft reviews, *required* annotated versions of promotional materials are needed. Each claim must link directly to an annotated source (label or other references), with specific lines highlighted. * **DTC TV Ads:** While not currently mandatory for early submission, it is highly recommended to submit Direct-to-Consumer (DTC) TV ads early for agency review due to their wide reach, even though the 2012 guidance on mandatory 45-day pre-dissemination review has been removed from the final Ad Promo guidance. * **Common FDA Issues:** Avoid submitting Form 356h or a cover letter in Module 1.2 or 1.15.1 for 2253s. Ensure the product label is consistently included in 1.14.6. For accelerated products, provide a separate annotated label for *each* material. External hyperlinks to webpages are not allowed; websites must be included as acceptable file formats in the annotated references section. * **Transition Period Strategy:** Companies should define resources, evaluate outsourcing vs. in-house capabilities, get trained on eCTD and Module 1 version 3.3, convert existing NDAs/BLAs to Mod 1 v3.3, and follow submission format history (e.g., amend paper submissions in paper, new submissions in eCTD). **Key Concepts:** * **eCTD (electronic Common Technical Document):** An electronic format for submitting applications, amendments, supplements, and reports to regulatory authorities, standardized across regions. * **Ad Promo Submissions:** Regulatory submissions related to advertising and promotional materials for pharmaceutical products. * **Form FDA 2253:** A form used to submit final samples of promotional materials to the FDA at the time of first dissemination. * **Accelerated Approval (Subpart H or E):** A regulatory pathway for drugs treating serious conditions with unmet medical needs, allowing approval based on surrogate endpoints, often requiring mandatory pre-review of promotional materials. * **Module 1.15:** A specific section within the eCTD Module 1 backbone (US version 3.3) designated for Ad Promo materials and related correspondence. * **Annotated Materials:** Promotional materials or references with specific claims or information highlighted and linked to their supporting sources (e.g., product label, journal articles). * **CDER (Center for Drug Evaluation and Research) & CBER (Center for Biologics Evaluation and Research):** Two centers within the FDA responsible for regulating drugs and biologics, respectively, with slight differences in Ad Promo submission requirements. **Examples/Case Studies:** * **Website vs. Print Ad for Dual Audience:** If a material serves both healthcare professionals and consumers, it should be submitted to the audience that will receive the bulk of the information. For a website with separate sections, separate sequences are ideal. For a print ad, if not exclusively for HCPs, it should be submitted as a consumer material. * **Multiple Indications/Review Divisions:** If a product has multiple indications falling under different CDER review divisions, it is recommended to keep the Ad Promo submissions for those indications separate.
Veeva CDB: A Clinical Data Platform for Complete and Concurrent Data
Veeva Systems Inc
/@VeevaSystems
Jun 12, 2020
This video provides an in-depth exploration of Veeva CDB, a clinical data platform designed to aggregate, harmonize, and prepare clinical trial data for analysis and regulatory submission. The presenter, a Data Manager, demonstrates the platform's capabilities through the Veeva CDMS workbench, showcasing how it helps manage the complexities of clinical data, from initial collection to final export. The core objective is to deliver clean, well-organized, and ready-to-use data faster, thereby optimizing clinical operations and ensuring compliance. The demonstration begins with an overview of the workbench interface, which provides data managers with a consolidated view of multiple studies. Key panels display progress in data collection, alongside critical study health indicators such as adverse events, unresolved queries, and overdue visits, enabling managers to prioritize their attention. The video then drills down into specific study data, illustrating how to navigate and interact with detailed data listings. These listings are designed to resemble spreadsheets, offering familiar concepts while incorporating "decorations" that highlight open queries, intentionally left blank fields, or data changes, facilitating efficient review and discrepancy identification. A significant portion of the presentation focuses on data reconciliation and discrepancy management. The presenter shows how to customize listings by adding columns from various data sources, such as central lab data and demographics, to perform side-by-side comparisons. This capability is crucial for identifying inconsistencies, like mismatched dates of birth from different sources. For more advanced data manipulation and complex queries, the platform integrates CQL (Clinical Query Language), allowing users with appropriate permissions to write custom queries directly, which then dynamically update the UI. The video also highlights real-time data synchronization with EDC (Electronic Data Capture) systems, ensuring that data managers are working with the most current information and can quickly route queries back to the source for resolution, reducing communication delays. Finally, the video details the process of creating export definitions, a critical step for preparing data for downstream systems and regulatory submissions. The platform offers a wizard-driven approach to build these definitions, with specialized augmentations for standards like SDTM (Study Data Tabulation Model). This includes automated mapping of study design terms to variable names, ensuring correct data types and date formats. Users can schedule exports in various formats (e.g., CSV, SAS) and inspect the technical properties of data columns, including variable names, data types, and code list transformations. This comprehensive approach to data management, reconciliation, and export underscores Veeva CDB's role in streamlining clinical data workflows, enhancing data quality, and supporting regulatory compliance. Key Takeaways: * Veeva CDB serves as a centralized clinical data platform that aggregates and harmonizes diverse data sources, ensuring data is clean, well-organized, and readily available for use. * The CDMS workbench provides data managers with a holistic view of clinical trials, offering insights into data collection progress and study health metrics like adverse events, unresolved queries, and overdue visits. * Interactive data listings are designed for intuitive review, resembling spreadsheets but enhanced with visual "decorations" that indicate open queries, intentionally left blank fields, or recent data changes. * The platform facilitates efficient discrepancy management by allowing users to filter, sort, and customize data listings, integrating data from multiple sources (e.g., central lab, demographics) for direct comparison and reconciliation. * Advanced data manipulation is supported through CQL (Clinical Query Language), enabling users to write complex queries for identifying discrepancies and performing transformations, with immediate reflection in the user interface. * Real-time data synchronization with EDC systems is a core feature, ensuring that data managers always work with the most up-to-date information and can quickly route queries back to the source, minimizing communication gaps. * Users can drill down from any data cell directly into the EDC system to review the context of the data within its original form, enhancing the efficiency of query resolution. * Automated query routing ensures that any new queries raised within Veeva CDB are automatically sent back to the relevant source system or site for prompt action. * Export definitions provide a structured and wizard-driven approach to prepare data for external systems and regulatory submissions, streamlining the process of data delivery. * The platform includes specialized augmentations for regulatory standards like SDTM, automatically applying correct variable names, data types, and date formats based on study design, significantly reducing manual effort and ensuring compliance. * Export jobs can be scheduled to run regularly and support various output formats, including CSV and SAS, catering to different downstream system requirements. * An "inspect mode" allows for a technical review of data properties within export definitions, enabling users to modify variable names, data types, and code list labels directly for precise transformations. * The entire process, from data review to export, follows a controlled workflow, moving from draft mode through inspection and readiness to final publication and job execution, ensuring data quality and governance. * Veeva CDB aims to reduce the time and effort traditionally associated with clinical data management, enhancing data quality, accelerating data readiness, and ensuring regulatory compliance. Tools/Resources Mentioned: * Veeva CDB (Clinical Data Platform) * Veeva CDMS (Clinical Data Management System) * Workbench application (within CDMS) * EDC (Electronic Data Capture) * CQL (Clinical Query Language) * SDTM (Study Data Tabulation Model) * CSV (Comma Separated Values) * SAS (Statistical Analysis System) Key Concepts: * **Clinical Data Management (CDM):** The process of collecting, managing, and analyzing data from clinical trials. * **Data Aggregation & Harmonization:** Combining data from disparate sources and standardizing its format and content for consistent analysis. * **Discrepancy Management:** The process of identifying, tracking, and resolving inconsistencies or errors within clinical data. * **Data Listings:** Tabular presentations of clinical data, often used for review, analysis, and reporting. * **Data Reconciliation:** Comparing data from different sources to identify and resolve discrepancies, ensuring data accuracy. * **Export Definitions:** Configurable templates or settings that define how clinical data should be prepared and exported for specific purposes, such as regulatory submissions or further analysis. * **SDTM Transformation:** The process of mapping and converting clinical trial data into the Study Data Tabulation Model (SDTM) format, a standard required by regulatory bodies like the FDA. * **Real-time Data Updates:** The capability of a system to receive and reflect changes in data as they occur, minimizing delays in information availability. * **Query Management:** The system and process for generating, tracking, and resolving queries related to clinical data discrepancies or missing information.
Ending the paper trail with REDCap: optimized workflows for screening, consenting, and compensating
MGH Martinos Center
/@MGHMartinosCenter
Apr 11, 2020
This video explores the successful digital transformation of administrative workflows in clinical research at the MGH Martinos Center, specifically focusing on replacing paper-based processes with REDCap. Olivia Rowe, a Clinical Research Coordinator, details how her team optimized subject screening, consenting, and compensation by leveraging REDCap's capabilities. The presentation highlights the numerous inefficiencies and compliance risks associated with paper forms, such as space consumption, outdated information, HIPAA vulnerabilities, and lack of flexibility. The implemented REDCap solution introduces digital safety screening, dynamic branching logic for tailored questionnaires (e.g., pregnancy screening), real-time eligibility feedback for participants, digital sign-offs for MRI technicians, and an integrated subject payment system. This initiative aims to alleviate administrative burdens, enhance data accuracy, and significantly improve regulatory compliance through robust audit trails and streamlined processes. Key Takeaways: * **Digital Transformation in Clinical Research:** The video directly addresses the administrative burden and compliance risks of paper-based workflows in clinical research, demonstrating a clear need for digital solutions to optimize operations within the life sciences sector. * **Workflow Optimization and Automation:** REDCap is effectively utilized to streamline critical processes like subject screening, consent, and compensation, showcasing the value of automating traditionally manual tasks through digital forms with features like branching logic and real-time feedback. * **Enhanced Regulatory Compliance:** Moving to digital platforms like REDCap significantly improves HIPAA compliance, provides thorough audit trails, and simplifies IRB approval processes through templated amendments, aligning with the strict regulatory requirements (e.g.ai helps clients navigate. * **Improved Participant Experience and Data Quality:** Digital forms empower participants to provide documentation, receive immediate eligibility feedback, and ensure more accurate and relevant data collection, reducing administrative overhead for research staff and improving overall data integrity. * **Interoperability and Customization Potential:** The discussion touches upon the ability to integrate with EMRs (like Epic) and the customizability of REDCap forms, highlighting the flexibility required for diverse research needs and the potential for broader data engineering initiatives. * **Scalability through Data Dictionaries:** The concept of sharing forms via a "data dictionary" allows for efficient replication and customization of standardized questionnaires across different labs, reducing redundant effort in setting up digital tools and promoting best practices.
Veeva Systems CEO talks assissting life sciences industry in the race to find a COVID-19 cure
CNBC Television
/@CNBCtelevision
Mar 26, 2020
This video provides an in-depth exploration of Veeva Systems' critical role in supporting the life sciences industry, particularly during the initial phase of the COVID-19 pandemic. Featuring an interview with Veeva CEO Peter Gassner, the discussion highlights how the cloud-based software company empowers pharmaceutical and biotech firms to manage clinical trial data, ensure regulatory compliance, and enhance commercial operations. The context of the interview is a volatile market, with the host, Jim Cramer, emphasizing Veeva's perceived indispensability despite stock fluctuations. Gassner elaborates on how Veeva's customers were at the forefront of addressing COVID-19, working on new tests, treatments, and vaccinations. He explains that the pandemic significantly disrupted traditional in-person interactions essential for both commercial activities (sales reps engaging healthcare providers) and clinical trials (researchers conducting studies). In response, Veeva rapidly enabled virtual engagement through its "Veeva Engage" product, which facilitates compliant remote connections between pharmaceutical sales representatives and doctors, as well as researchers. Notably, this Zoom-based solution was offered free to the industry for a period, leading to a tenfold increase in usage within just two weeks, underscoring its immediate and vital utility. The conversation also delves into Veeva's impressive business growth, having achieved a $1 billion revenue milestone ahead of schedule and setting an ambitious new target of $3 billion by 2025. Gassner clarifies that Veeva's product portfolio has expanded significantly beyond its initial "Vault" offering, now encompassing a broad suite of solutions. He characterizes the life sciences industry as largely counter-cyclical, maintaining consistent demand for medicines even during economic downturns, although temporary disruptions to new clinical trials can occur. Gassner stresses that challenging times often serve as a catalyst for innovation, driving companies to become more productive and adaptable. Furthermore, Gassner provides concrete examples of Veeva's impact, citing its work with major pharmaceutical companies like Bristol-Myers Squibb. This includes assisting with large-scale mergers (e.g., Celgene integration), streamlining quality and manufacturing processes, supporting clinical trials, and optimizing interactions with healthcare professionals. He also introduces a significant new offering, the "Veeva Data Cloud," which focuses on leveraging data science and big data related to patient information. This initiative is crucial for advancing precision medicine by enabling companies to better understand patient populations and deliver targeted therapies, showcasing Veeva's commitment to cutting-edge data solutions. Key Takeaways: * **Veeva's Foundational Role in Life Sciences:** Veeva Systems provides essential cloud-based software solutions that enable pharmaceutical and life sciences companies to effectively manage clinical trial data, ensure adherence to complex regulations, and optimize their commercial operations. This comprehensive support positions Veeva as a critical partner across the drug development and commercialization lifecycle. * **Adaptation to Virtual Engagement during Crisis:** The COVID-19 pandemic necessitated a rapid shift from in-person to virtual interactions for both pharmaceutical sales and clinical research. Veeva played a pivotal role in facilitating this transition, demonstrating the immediate need for robust, compliant virtual engagement platforms in the industry. * **Veeva Engage: A Critical Virtual Solution:** Veeva Engage, a product built on Zoom, was offered free to the industry during the pandemic to enable compliant remote connections between pharmaceutical sales reps and doctors. Its rapid adoption, with a 10x increase in usage, highlights its effectiveness and the urgent demand for such tools. * **Resilience and Counter-Cyclical Nature of Life Sciences:** The life sciences industry is characterized as largely counter-cyclical, meaning the demand for medicines generally remains stable even during economic downturns. This inherent stability makes the sector resilient, though temporary disruptions, such as the postponement of new clinical trials, can occur. * **Innovation as a Response to Adversity:** Challenging periods, like the pandemic, act as powerful catalysts for innovation within the life sciences sector. Companies are driven by necessity to find new, more efficient, and productive ways to operate, leading to technological advancements and process improvements. * **Significant Growth and Ambitious Future Goals:** Veeva Systems has demonstrated remarkable growth, achieving $1 billion in revenue ahead of its 2020 target and setting an ambitious new goal of $3 billion by 2025. This trajectory underscores its strong market position, expanding influence, and confidence in continued growth. * **Diversified Product Portfolio Beyond Veeva Vault:** While Veeva Vault was a foundational product, Veeva's offerings have significantly broadened. The company now provides a comprehensive suite of solutions that address various aspects of pharmaceutical operations, from R&D and quality to commercial and patient data management. * **Enterprise-Level Support for Major Pharma:** Veeva provides critical support for complex, large-scale initiatives for major pharmaceutical clients, such as assisting Bristol-Myers Squibb with the integration of a significant merger (Celgene). This demonstrates its capability to handle intricate enterprise requirements and drive operational efficiency. * **End-to-End Solutions Across the Pharma Value Chain:** Veeva's services span the entire pharmaceutical value chain, including quality and manufacturing, clinical trials, and commercial interactions with healthcare providers. This integrated approach helps clients streamline operations from drug development through market delivery. * **Veeva Data Cloud for Precision Medicine:** The introduction of Veeva Data Cloud signifies a strategic move into advanced data science and big data analytics focused on patient information. This product is crucial for the advancement of precision medicine, enabling pharmaceutical companies to better understand patient populations and develop more targeted and effective therapies. * **Importance of Compliant Remote Interactions:** A core tenet of Veeva's offerings, particularly during the pandemic, is ensuring that remote interactions between pharmaceutical sales representatives and healthcare professionals are conducted in a fully compliant manner, adhering to strict industry regulations. Tools/Resources Mentioned: * Veeva CRM * Veeva Engage (based on Zoom) * Veeva Vault * Veeva Data Cloud Key Concepts: * **Cloud-based software:** Software delivered over the internet, accessible from any device. * **Life sciences industry:** Encompasses pharmaceutical, biotech, medical device, and diagnostics companies. * **Clinical trial data:** Information collected during human clinical trials to assess the safety and efficacy of new drugs or treatments. * **Regulatory compliance:** Adherence to rules and regulations set by bodies like the FDA and EMA, crucial in the pharmaceutical sector. * **Commercial operations:** Activities related to marketing, sales, and distribution of pharmaceutical products. * **Virtual engagement:** Conducting business interactions and activities remotely using digital platforms. * **Counter-cyclical industry:** An industry whose performance is inversely related to the overall economic cycle. * **Precision medicine:** An approach to disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person. * **Data science and big data:** Methodologies and technologies for analyzing large, complex datasets to extract insights, particularly relevant for patient data in healthcare. Examples/Case Studies: * **Bristol-Myers Squibb (BMS):** Veeva assisted BMS with its merger with Celgene, facilitating an expeditious integration. Veeva also supports BMS across various functions, including quality and manufacturing, clinical trials, and interactions with doctors' offices.
eTMF
Sarjen Systems Pvt. Ltd.
/@SarjenSysPvtLtd
Mar 26, 2020
This video provides an in-depth exploration of Electronic Trial Master Files (eTMFs), contrasting their benefits and regulatory acceptability against the significant challenges posed by traditional paper-based TMF systems. The presenter begins by establishing the regulatory context, highlighting that eTMF standards are acceptable to authorities, specifically referencing Directive 2005/28/EC and related guidance in Volume 10 of the rules governing medicinal products in the EU. This foundational premise sets the stage for understanding why a shift to electronic systems is not just an operational improvement but a regulatory imperative. The core of the presentation then pivots to detailing the "actual scenario" where TMFs are commonly maintained on hardcopy for both bioequivalence (BA/BE) and clinical trial (CT) studies. This traditional approach is plagued by several critical issues: the unavailability of standard templates, making it difficult to inherit structures for similar products; cumbersome version management of documents, leading to confusion; limited accessibility of documents across multiple departments; and a critical lack of a robust audit trail. These challenges collectively hinder efficiency, increase operational risk, and complicate regulatory oversight, underscoring the urgent need for a more streamlined and compliant solution. The video then introduces the electronic TMF as a simplified approach designed to address these pervasive challenges. It elaborates on how an eTMF system facilitates a quick and efficient review process compared to paper TMFs. Key advantages include allowing inspectors and auditors direct access to documents, ensuring that eTMF documents are evidently authentic, complete, and legible copies of originals. Furthermore, eTMF systems incorporate validated methods to prevent unauthorized changes, track the status of all TMFs conveniently, and enable organizations to effectively manage post-submission queries from regulatory authorities. The system's design emphasizes easy accessibility through intuitive folder and file naming conventions, reducing the need for inspectors to open numerous documents. It also supports opening multiple documents simultaneously for comparison, providing access to the same document type across various studies, sponsors, and internal departments for review and comment, and comprehensive TMF lifecycle management. The culmination of these features is the ability to generate customizable reports, which significantly assists in overall proficiency. The tangible benefits of adopting an eTMF system are quantified and emphasized, illustrating a substantial positive impact on operational efficiency and cost reduction. The video claims a reduction in operational costs by up to 60% and a decrease in efforts related to maintaining multiple versions of eTMFs, thereby avoiding confusion regarding the latest version for submission. A particularly significant advantage highlighted is the aid in developing virtual inspections, which can improve the efficiency of the inspection process by up to 80%. The system also ensures easy and continual updates for ongoing trials, reinforcing its utility throughout the clinical trial lifecycle. The presentation concludes with a call to action for a demo, suggesting the immediate applicability and value of such a system. Key Takeaways: * **Regulatory Acceptance of eTMFs:** Electronic Trial Master Files are officially recognized and accepted by regulatory authorities, specifically citing EU Directive 2005/28/EC and Volume 10 guidance, making their adoption a compliant and strategic move for pharmaceutical companies. * **Critical Pain Points of Paper TMFs:** Traditional hardcopy TMFs suffer from significant drawbacks including a lack of standard templates, poor version control, limited document accessibility across departments, and the absence of a reliable audit trail, all of which impede efficiency and compliance. * **Enhanced Review and Accessibility:** eTMF systems enable quick and efficient document review, providing inspectors and auditors direct access to TMF documents, which are guaranteed to be authentic, complete, and legible copies of originals. * **Document Integrity and Auditability:** A robust eTMF system incorporates validated methods to prevent unauthorized changes to documents and provides comprehensive tracking of the status of all TMFs, ensuring data integrity and a clear audit trail. * **Streamlined Query Management:** Organizations can significantly benefit from eTMFs by effectively managing post-submission queries raised by regulatory authorities, thanks to improved document organization and accessibility. * **Intuitive Document Organization:** eTMFs utilize easy accessibility with logical folder and file naming conventions, allowing inspectors and auditors to readily identify and locate needed documents without sifting through numerous irrelevant files. * **Comparative Analysis Capability:** The ability to open and view more than one document at a time within an eTMF system facilitates direct comparison, which is crucial for thorough review and analysis during inspections or internal audits. * **Cross-Study and Departmental Access:** eTMFs allow for providing access to the same type of document across all study sponsors, products, and internal departments, fostering collaboration and consistent document review and comment processes. * **Comprehensive TMF Lifecycle Management:** The system supports full lifecycle management of TMF documents, from creation through archiving, ensuring all stages are managed efficiently and compliantly. * **Customizable Reporting for Proficiency:** The capability to generate customizable reports from the eTMF system assists in overall proficiency, offering valuable insights into document status, compliance, and operational metrics. * **Significant Cost and Efficiency Gains:** Adopting an eTMF can lead to substantial operational cost reductions, cited as up to 60%, and significantly reduced efforts in managing multiple document versions, minimizing confusion and errors. * **Facilitation of Virtual Inspections:** eTMFs are instrumental in aiding the development and execution of virtual inspections, improving the efficiency of the inspection process by up to 80%, a critical advantage in modern regulatory environments. * **Continuous Updates for Ongoing Trials:** The electronic nature of eTMFs allows for easy and continual updates for ongoing trials, ensuring that the TMF remains current and compliant throughout the duration of a study. Key Concepts: * **eTMF (Electronic Trial Master File):** A digital system for managing and storing essential documents and records related to a clinical trial, ensuring regulatory compliance and operational efficiency. * **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. * **Directive 2005/28/EC:** An EU directive laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorization of the manufacturing or importation of such products. * **Volume 10 of the Rules Governing Medicinal Products in the EU:** A comprehensive set of guidelines and regulations for medicinal products within the European Union, providing detailed guidance on various aspects including clinical trials and documentation.
Top Considerations When Evaluating Cloud based Quality Management Systems
Veeva Systems Inc
/@VeevaSystems
Mar 16, 2020
This video provides an in-depth exploration of the critical considerations when evaluating cloud-based Quality Management Systems (QMS) in the life sciences sector. Mike Jovanis, VP of Vault Quality at Veeva Systems, traces the evolution of electronic QMS from its inception with 21 CFR Part 11 in the late 1990s, through its maturation into web-based applications, to the current landscape dominated by cloud solutions. He establishes that the industry has reached a significant inflection point, necessitating a fundamental shift in how organizations approach QMS vendor selection and system implementation. Jovanis elaborates on the historical context, noting that early eQMS implementations were often fragmented and not viewed as strategic enterprise systems. While some organizations later consolidated these systems, they often did so on older technologies. The recent advent of cloud-based solutions, such as Veeva Vault, has created immense pressure on legacy vendors, many of whom are private equity-owned and struggle with the high investment and cultural "cloud DNA" required to adapt. He argues that history shows previous leaders in a technology space rarely become future leaders during major technological turnovers, highlighting the inherent difficulties legacy companies face in reinventing themselves. From Veeva's perspective, the video emphasizes the "industry cloud" approach, where a mature and stable platform like Vault is used to commercialize purpose-built applications for quality systems. This methodology focuses on delivering demonstrated best practices, driving industry standardization, and ensuring rapid time to value without the extensive requirements definition and configuration processes typical of older technologies. Jovanis details how Veeva has consolidated solutions for quality document management, QMS, CGXP training, and manufacturing shop floor content delivery onto a single Vault platform, enabling sophisticated business process connections—such as linking change control between QDM and QMS, or triggering training based on specific events—that were impossible with siloed legacy systems. The core message underscores that organizations must approach QMS evaluations with a long-term strategic mindset, selecting a partner for the next decade or more. This requires granular evaluations that not only assess core functional differences but also understand the transformative benefits that modern cloud solutions can offer. Jovanis stresses the importance of recognizing that the industry has fundamentally changed, and traditional thinking about QMS vendors and implementations is no longer adequate for achieving strategic advantages and future-proofing operations in a highly regulated environment. Key Takeaways: * **Evolution of eQMS:** The electronic Quality Management System (eQMS) market emerged with 21 CFR Part 11 in the late 1990s, initially comprising client-server software that evolved into single-instance, web-based applications. These systems were often implemented incrementally and lacked enterprise-wide strategic integration. * **Industry Inflection Point:** The QMS landscape has reached a critical inflection point due to the introduction of cloud-based solutions, which has fundamentally altered vendor dynamics and competitive pressures. This necessitates a fresh perspective on QMS evaluations. * **Challenges for Legacy Vendors:** Incumbent technology leaders rarely become future leaders during significant technological shifts. Legacy QMS vendors often face substantial hurdles, including the need for high profitability (especially if private equity-owned), insufficient investment for re-platforming, and a lack of inherent "cloud DNA" in their organizational structure and processes. * **Importance of "Cloud DNA":** Successfully operating in the cloud requires a distinct organizational culture, development methodology, and delivery model. Companies lacking this "cloud DNA" struggle to adapt, even with acquisitions, making their transformation efforts often ineffective. * **Veeva's Industry Cloud Strategy:** Veeva leverages its mature Vault platform to deliver purpose-built applications for quality systems, embodying an "industry cloud" approach. This strategy focuses on providing demonstrated best practices, driving industry standardization, and enabling rapid time to value. * **Transformative Outcomes:** Modern cloud QMS solutions aim for transformative outcomes beyond mere technology replacement. They address standardization challenges, consolidate disparate applications, and streamline complex workflows, offering strategic advantages over incremental improvements. * **Integrated Platform Benefits:** Consolidating various quality solutions (e.g., quality document management, QMS, CGXP training, shop floor content delivery) onto a single platform like Veeva Vault enables powerful business process connections. This allows for seamless integration, such as linking change control between different quality functions or triggering training based on specific events. * **Broader Ecosystem Integration:** The benefits extend beyond quality, with integrated platforms facilitating sophisticated business process connections between regulatory and quality functions, enhancing overall compliance and operational efficiency across the life sciences value chain. * **Long-Term Vendor Partnership:** Organizations should evaluate QMS vendors as strategic partners for a decade or more. This requires a critical assessment of the vendor's long-term viability, adaptability to future technology, and genuine cloud capabilities, rather than just current feature sets. * **Granular and Transformative Evaluations:** Due diligence must involve granular-level evaluations that not only scrutinize core functional differences but also deeply understand the transformative benefits that modern cloud solutions can unlock. These benefits are crucial for building a compelling business case for a significant, long-term investment. * **Rethink QMS Strategy:** Given the dramatic changes in the industry, organizations must adopt a new mindset for QMS evaluations, moving beyond the incremental, iterative approaches of the past 20 years. The focus should be on strategic, future-proof solutions that leverage the full potential of cloud technology. Tools/Resources Mentioned: * **Veeva Vault:** A mature and stable platform serving as the foundation for Veeva's industry-specific cloud applications. * **Veeva Vault Quality Applications:** Specific solutions built on the Vault platform, including Quality Document Management, QMS, CGXP Training, and tablet-based content delivery on the manufacturing shop floor. Key Concepts: * **21 CFR Part 11:** A U.S. Food and Drug Administration (FDA) regulation governing electronic records and electronic signatures, which significantly influenced the early development of eQMS. * **Client-Server Software:** An older software architecture where applications run on individual computers ("clients") and connect to a central server for data and services, contrasting with modern web and cloud models. * **Industry Cloud:** A specialized cloud computing model tailored to meet the unique requirements, regulations, and best practices of a specific industry, such as life sciences, offering purpose-built applications and integrated workflows. * **Cloud DNA:** Refers to the intrinsic organizational culture, operational processes, and technological expertise required to effectively develop, deploy, and maintain cloud-native products and services. * **Transformative Outcomes:** Significant and fundamental improvements in business processes, efficiency, and strategic capabilities, rather than just minor or incremental enhancements. * **Rapid Time to Value:** The speed at which an organization can realize tangible benefits and a return on investment from implementing a new system or solution. Examples/Case Studies: * **Veeva Vault Integrated Quality Solutions:** The video highlights how Veeva Vault consolidates quality document management, QMS, CGXP training, and shop floor content delivery onto a single platform. This integration enables specific business process connections, such as linking change control between quality document management and QMS, or triggering training based on specific events. * **Regulatory and Quality Connections:** Veeva has also developed sophisticated business process connections between regulatory and quality applications within its broader ecosystem, demonstrating the power of an integrated platform to streamline workflows across different functions.
Practical experience with Cloud Qualification
Epista Life Science
/@epistalifescience6136
Feb 27, 2020
This video provides an in-depth exploration of practical cloud qualification within regulated GxP environments, particularly for the life sciences industry. Epista Life Science, a consultancy focused on improving regulatory compliance, presents a structured approach to address the complexities of moving IT solutions to the cloud. The discussion begins by establishing that while cloud adoption offers numerous benefits, it does not inherently eliminate compliance challenges. Instead, it shifts the nature of control and responsibility, necessitating a robust oversight strategy from the regulated company. The presentation delves into various "as a Service" models, from colocation to Software as a Service (SaaS), highlighting how the degree of control relinquished to the cloud service provider increases with each model. A core theme is the critical importance of oversight, as regulated companies transfer procedural controls for aspects like patching, version upgrades, and underlying IT stack maintenance to the provider. The speakers emphasize that a successful cloud transition requires a comprehensive plan encompassing vendor assessment, service level agreement (SLA) negotiation, and a crucial, often overlooked, exit strategy to ensure data control and portability. A significant portion of the webinar is dedicated to a unique "cloud compliance verification" framework. This framework utilizes a detailed spreadsheet to systematically link relevant regulatory requirements (such as EU Annex 11 and 21 CFR Part 11) to the specific responsibilities of both the cloud service provider and the regulated customer. A practical case study involving the qualification of Office 365 for GxP activities illustrates how this framework is applied, referencing Microsoft's standard SLAs and SOC 2 reports. The video concludes by introducing "Automated Boost," a tool designed to automate manual compliance tasks and periodic reviews, demonstrating its use for checking multi-factor authentication (MFA) status and monitoring Microsoft's Message Center for critical updates, thereby enabling continuous control and compliance in the cloud. Key Takeaways: * **Cloud Adoption Shifts, Not Eliminates, Compliance Burden:** Moving to cloud solutions like Office 365 or Veeva does not make GxP compliance challenges disappear; it transforms them, requiring regulated companies to maintain vigilant oversight and adapt their control strategies. * **Oversight is Paramount in Cloud Environments:** When relinquishing control over underlying IT infrastructure (e.g., patching, OS maintenance, firewall configurations) to a cloud service provider, the regulated company must establish robust oversight mechanisms to ensure the provider's procedures meet compliance standards. * **Structured Cloud Qualification Process:** A successful cloud transition should follow a familiar IT implementation process, including a detailed planning phase (cloud strategy, vendor assessment, SLA negotiation), an explicit exit strategy, and a tailored implementation phase. * **The Importance of an Exit Strategy:** A clear exit strategy is an integral part of cloud transition planning, addressing how data will be extracted and retained in a usable format if the company decides to change providers or return to an on-premise solution, ensuring continued data control. * **"Light IQ" for Cloud Solutions:** For cloud implementations, the Installation Qualification (IQ) can be a "light IQ," focusing primarily on the client-specific configuration of the cloud account, environment, users, groups, and integrations, rather than extensive testing of the underlying infrastructure managed by the provider. * **Cloud Compliance Verification Framework:** A "massive spreadsheet" approach is recommended to systematically link general regulatory requirements (e.g., EU Annex 11, 21 CFR Part 11) to specific interpretations, additional client-specific requirements, and the documented procedural responsibilities of both the cloud service provider and the customer. * **Leveraging Cloud Service Provider Documentation:** Regulated companies should rely on and reference documentation provided by the cloud service provider, such as standard SLAs and third-party audit reports (e.g., SOC 2 reports for Microsoft Office 365), to demonstrate the provider's adherence to controls. * **Continuous Operation and Maintenance (O&M) with a "Control Wheel":** Cloud compliance requires ongoing O&M activities, which can be organized using a "control wheel" defining daily (e.g., general cloud management), monthly (e.g., account cleanup), quarterly (e.g., account access reviews), and yearly (e.g., re-verification of cloud compliance) recurring tasks. * **Automating Repetitive Compliance Tasks:** Many recurring cloud O&M tasks, such as checking system health, user configurations (like MFA status), or monitoring provider updates, are manual and time-consuming. Automation tools can significantly save time and money by performing these "point-and-click" activities. * **Monitoring Provider Updates (Microsoft Message Center):** For SaaS solutions like Office 365, it is critical to regularly monitor the provider's message center (e.g., Microsoft Message Center) for notifications on updates, issues, and planned changes, assessing their impact on control and compliance. * **Data Lifecycle and Cloud Retirement:** Just like on-premise systems, cloud systems require consideration for data lifecycle management and system retirement, ensuring data integrity and accessibility even after a system is decommissioned or a cloud service is terminated. **Tools/Resources Mentioned:** * **Automated Boost:** A record and replay test automation tool demonstrated for monitoring and automating compliance tasks in cloud environments. * **Microsoft Office 365:** Used as a practical case study for cloud qualification and automation. * **Microsoft Azure:** Mentioned in the context of Microsoft's cloud infrastructure responsibilities. * **Microsoft Message Center:** A platform for Microsoft to communicate updates, issues, and planned changes to its services. **Key Concepts:** * **XaaS (Everything as a Service):** A broad category of cloud computing services, encompassing Infrastructure as a Service (IaaS), Platform as a Service (PaaS), and Software as a Service (SaaS), each with varying levels of control shared between provider and customer. * **Cloud Qualification:** The process of formally documenting that a cloud-based system or service meets predefined regulatory requirements and is fit for its intended GxP-regulated purpose. * **Cloud Compliance Verification:** A methodology, exemplified by a detailed spreadsheet, for systematically mapping regulatory requirements (e.g., GxP, 21 CFR Part 11, EU Annex 11) to the controls and responsibilities of both the cloud service provider and the regulated customer. * **Light IQ (Installation Qualification):** A streamlined approach to IQ for cloud solutions, focusing on the configuration and integration aspects managed by the customer, rather than extensive testing of the underlying infrastructure which is the provider's responsibility. * **Control Wheel:** A visual framework used to define and schedule recurring operational and maintenance activities necessary to maintain continuous compliance and control over cloud solutions, categorizing tasks by frequency (daily, monthly, quarterly, yearly). * **GxP (Good x Practice):** A collection of quality guidelines and regulations for various aspects of regulated industries, particularly life sciences, including Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP). * **21 CFR Part 11:** Regulations from the U.S. Food and Drug Administration (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. * **EU Annex 11:** An annex to the European Union's Good Manufacturing Practice (GMP) guidelines, providing specific requirements for computerized systems used in pharmaceutical manufacturing. * **MFA (Multi-Factor Authentication):** A security system that requires more than one method of authentication from independent categories of credentials to verify the user's identity for a login or other transaction.
Streamline Change Control and Variation Management
Veeva Systems Inc
/@VeevaSystems
Feb 20, 2020
This video provides an in-depth exploration of streamlining change control and variation management within the biopharmaceutical industry, focusing on how Veeva's unified Quality and Regulatory Information Management (RIM) solutions address long-standing challenges. The presentation, led by Veeva's Quality and Regulatory strategy teams, highlights the complexities of managing product changes that often have significant regulatory impact. It emphasizes that traditional, manual, and siloed approaches lead to inefficiencies, compliance risks, and delayed product availability, setting the stage for Veeva's integrated platform as a transformative solution. The core of the discussion revolves around Veeva's vision to build an "industry cloud for Life Sciences," offering best-of-breed applications designed with industry best practices and compliance in mind. The speakers detail the functionalities of Veeva's Vault Quality Suite (including Quality Docs, Station Manager, Training, and QMS) and the Vault RIM Suite (Registrations, Submissions, Submissions Publishing, and Submissions Archive). A key message is that while these are presented as separate applications for licensing, they are built on a single Vault platform and data model, enabling seamless data flow and process unification, particularly for complex processes like change control. The video then delves into a specific workflow demonstrating how a change request initiated in Vault QMS triggers a regulatory impact assessment within Vault Registrations. This bi-directional integration allows quality teams to quickly understand the regulatory implications (impacted licenses, local market requirements) and regulatory teams to update filing statuses, which are then visible in real-time within QMS. This automation significantly reduces manual effort, improves compliance, optimizes costs, and enables more informed product shipment decisions, ultimately preventing potential short supply situations for critical medicines. The Q&A session further clarifies technical aspects, integration capabilities (e.g., with ERP systems), and Veeva's roadmap for regulatory standards like IDMP. Key Takeaways: * **Complexity of Change Control:** Change control in biopharma is a highly complex, multi-step process that can take anywhere from six months to two years to complete. Large organizations may evaluate tens of thousands of change requests and approve upwards of 15,000 changes annually, many with significant downstream regulatory impact. * **Challenges of Legacy Systems:** Traditional approaches rely on separate, siloed quality and regulatory systems, leading to manual "swivel-chair" processes, data duplication, and a lack of real-time visibility. Regulatory impact assessments, often managed via spreadsheets, are cumbersome and prone to errors, hindering compliance and extending cycle times. * **Veeva's Unified Platform Approach:** Veeva aims to provide an "industry cloud for Life Sciences" with best-of-breed applications (Vault Quality and Vault RIM suites) built on a single, multi-tenant cloud platform. This unified approach manages content, data, and business processes seamlessly, ensuring consistency and compliance. * **Vault Quality Suite Components:** The suite includes Vault Quality Docs for GxP document management, Vault Station Manager for shop floor access, Vault Training for managing training matrices, and Vault QMS for structured data management of quality events like deviations, CAPA, audits, risk management, and change control. * **Vault RIM Suite Components:** Designed to overcome regulatory fragmentation, the RIM suite comprises Vault Registrations (for tracking, regulatory impact assessments, xEVMPD/IDMP), Vault Submissions (for content planning, authoring), Vault Submissions Publishing, and Vault Submissions Archive, all leveraging a single data model for end-to-end visibility. * **Streamlined QMS-RIM Integration:** A key benefit is the automated, bi-directional integration between Vault QMS and Vault Registrations. This allows for the seamless exchange of information regarding change controls and their regulatory impact, eliminating manual handoffs and reducing errors. * **Automated Regulatory Impact Assessment:** When a change request is created in QMS, the system can automatically trigger a regulatory impact assessment in Registrations. This identifies impacted licenses and local market requirements, feeding this critical information back to QMS to inform decisions on whether to proceed with the change. * **Real-time Regulatory Status Visibility:** As regulatory filings progress and approvals are received from health authorities, their status is automatically updated and made visible within QMS. This real-time information is crucial for making accurate and timely product shipment decisions. * **Significant Business Benefits:** Unifying change control across quality and regulatory leads to greater compliance, cost optimization through reduced manual effort and faster cycle times, and improved decision-making for product shipments, ultimately preventing critical medicine shortages. * **IDMP Implementation Strategy:** Veeva currently supports xEVMPD and is committed to incrementally building out IDMP functionality. The strategy involves developing features as the EMA releases clearer implementation guide details, leveraging Veeva's three-release-per-year cycle. * **GxP System Change Management:** Vault QMS fully supports managing change requests specifically related to GxP systems, offering flexibility to configure multiple types of changes within the change control workflow process. * **Productized Connector:** The integration between Vault QMS and Vault Registrations is a productized connector, not custom code. It is included with active subscriptions to both modules and requires configuration, such as mapping products and lifecycle states between the two systems. * **ERP Integration Capabilities:** Vault QMS can integrate with ERP systems for various purposes, including placing impacted batches on hold or importing master data, ensuring data consistency and streamlined processes across the enterprise landscape. * **Flexible Change Plan Definition:** While the delivered application suggests a high-level change plan for initial impact assessment, the workflow within Vault QMS can be configured to align with an organization's preference for defining a full change management plan before initiating impact assessments. Tools/Resources Mentioned: * Veeva Vault Quality Suite (Vault Quality Docs, Vault Station Manager, Vault Training, Vault QMS) * Veeva Vault RIM Suite (Vault Registrations, Vault Submissions, Vault Submissions Publishing, Vault Submissions Archive) * EMA Gateway * ERP systems (as potential integration points) * Excel spreadsheets, Microsoft Project (mentioned as legacy tools for content plans) Key Concepts: * **Change Control:** A formal, documented process to manage and track all changes made to a product, system, or process, ensuring they are introduced in a controlled and coordinated manner. * **Variation Management:** The process of managing changes to approved regulatory submissions for medicinal products, often requiring communication and approval from health authorities. * **Unified Quality and Regulatory Information Management (RIM):** An integrated approach that combines quality management systems (QMS) with regulatory information management systems to create a seamless flow of data and processes, enhancing efficiency and compliance. * **Regulatory Impact Assessment:** The critical step of evaluating how a proposed change will affect existing regulatory approvals, licenses, and submission requirements in various markets. * **Local Disposition:** The determination of specific regulatory actions or filings required in individual local markets based on the outcome of a regulatory impact assessment. * **GxP:** A comprehensive set of guidelines and regulations (e.g., Good Manufacturing Practice, Good Clinical Practice) that ensure the quality, safety, and integrity of products and processes in the life sciences industry. * **21 CFR Part 11:** A regulation from the U.S. Food and Drug Administration (FDA) that sets forth the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. * **xEVMPD (extended EudraVigilance Medicinal Product Dictionary):** A European standard for the electronic submission of medicinal product data to the European Medicines Agency (EMA). * **IDMP (Identification of Medicinal Products):** A set of international ISO standards aimed at providing a globally consistent way to identify and exchange information on medicinal products. * **Industry Cloud:** A specialized cloud computing platform tailored to the specific needs, regulations, and best practices of a particular industry, such as life sciences. * **Swivel-Chair Process:** A term used to describe inefficient manual data transfer between disconnected systems, often involving re-keying information, leading to errors and delays. Examples/Case Studies: * The video uses the example of changing a piece of manufacturing equipment to illustrate the complex regulatory impact assessment process, including identifying impacted licenses and local market requirements. * It cites real-world examples of larger organizations evaluating tens of thousands of change requests annually and approving upwards of 15,000 changes, highlighting the sheer volume and complexity involved. * Another example mentioned is a single product potentially undergoing over 200 changes in a given year, underscoring the continuous nature of change management in the industry.
Livia - AI for Veeva CRM
IT Lab Brasil
/@itlabbrasil2587
Feb 19, 2020
This video provides an introduction to Livia, an Artificial Intelligence assistant specifically designed for integration with Veeva CRM, targeting sales representatives within the pharmaceutical industry. The presentation highlights a common challenge faced by pharma sales reps: the significant time and effort required to analyze complex CRM reports and plan their daily activities, often leading to pressure and distress. Livia is positioned as a solution to this problem, aiming to streamline data exploration and insight generation, thereby enhancing sales force effectiveness and efficiency. The core functionality of Livia revolves around its ability to act as a virtual AI assistant directly within Veeva My Site. It is engineered to explore and synthesize data from the CRM system, combining it with external market and territory information. This comprehensive data analysis allows Livia to provide sales reps with relevant insights that would otherwise require extensive manual effort or specialized business intelligence skills. The user interaction model is conversational, enabling reps to either select from a predefined list of questions or type their own queries using a keyboard interface. Upon answering a question, Livia can offer further options or drill-down capabilities directly within the Veeva CRM environment, such as checking specific customer data like "Mary Clark." Furthermore, Livia operates with a robust back-office system that generates real-time reports, reflecting trends and addressing the main concerns of the sales rep team. This real-time feedback mechanism allows for continuous adjustment of Livia's answers to align with specific sales team needs and business objectives, ensuring the information provided is always relevant and actionable. The AI is also designed to be a "fast learner," implying that its accuracy and helpfulness improve with increased user interaction. The overarching goal is to empower sales reps to achieve better results faster, easier, and with significant time savings, effectively democratizing data-driven decision-making without requiring them to become business intelligence experts. Key Takeaways: * **Addressing Sales Rep Inefficiency:** The video identifies a critical pain point for pharmaceutical sales representatives: the excessive time spent analyzing complex CRM reports and planning activities, which can lead to stress and reduced productivity. * **AI for Veeva CRM Integration:** Livia is introduced as an AI assistant specifically developed to integrate seamlessly with Veeva CRM, a leading platform in the pharma industry, enhancing its utility for sales teams. * **Comprehensive Data Exploration:** The AI assistant is capable of exploring not only internal Veeva CRM data but also external market and territory information, providing a holistic view for sales planning and strategy. * **Intuitive Conversational Interface:** Sales reps can interact with Livia through a chat interface, asking questions either from a predefined list or by typing custom queries, making data access user-friendly and efficient. * **Actionable Insights within CRM:** After providing answers, Livia can offer additional options or direct actions within the Veeva CRM system, such as reviewing specific customer data, facilitating immediate application of insights. * **Real-time Reporting and Trends:** Livia is supported by a back-office system that delivers real-time reports, highlighting trends and key concerns relevant to the sales team, ensuring up-to-date information. * **Customizable and Adaptive Answers:** The AI's responses can be adjusted to meet the specific needs and business context of individual sales teams, ensuring the relevance and utility of the information provided. * **Continuous Learning Mechanism:** Livia is designed to be a "fast learner," meaning its performance, accuracy, and helpfulness improve over time as sales representatives interact with it more frequently. * **Empowering Non-BI Professionals:** A key benefit is enabling sales reps to leverage advanced data insights and analytics without needing specialized business intelligence skills, democratizing data-driven decision-making. * **Improved Sales Performance and Time Savings:** The ultimate promise of Livia is to help sales teams achieve better results faster, easier, and with significant time savings, by optimizing their planning and preparation processes. Tools/Resources Mentioned: * Veeva CRM * Livia (AI Assistant) * Veeva My Site Key Concepts: * **AI Assistant:** An artificial intelligence program designed to help users by performing tasks or providing information, often through conversational interfaces. * **Veeva CRM Integration:** The process of connecting an application or system directly with Veeva CRM to leverage its data and functionalities. * **Real-time Reporting:** The capability to generate and view reports instantly as data becomes available, providing up-to-the-minute insights. * **Data Exploration:** The process of discovering patterns, trends, and anomalies in data, often using visual methods and interactive tools. * **Commercial Operations Optimization:** The strategic improvement of processes, technologies, and people within a company's commercial functions to enhance efficiency and effectiveness. Examples/Case Studies: * The video uses the example of a sales rep needing to "check the data of Mary Clark" to illustrate how Livia can provide specific customer-related information and further options within Veeva CRM.
Gens and Associates - 2020 World Class RIM - Structured Data Submissions
Gens and Associates
/@gensandassociates3638
Jan 24, 2020
This video provides an in-depth exploration of Section six, "Structured Data Submissions," from the 2020 World Class RIM (Regulatory Information Management) survey conducted by Gens and Associates. The speaker, Kelly NAT, guides viewers through nine questions designed to assess approaches, costs, and resource requirements related to both existing and upcoming structured data submission mandates within the pharmaceutical and life sciences industries. The primary objective is to gather comprehensive data on how organizations are currently managing these critical regulatory submissions and their preparedness for future requirements, particularly those from the European Medicines Agency (EMA). The discussion begins by addressing current structured data submission requirements, focusing on the capabilities and solutions companies have in place. Question 33 probes the status of existing capabilities, listing various submission types and the diverse solutions employed, such as manual population of internal tools, direct electronic submission from internal systems, reliance on external vendors, or direct entry into Health Authority portals. The survey allows for multiple selections per row, acknowledging that companies often utilize hybrid approaches. Following this, Question 34 specifically targets the handling of xevMPD third acknowledgment records received from the EMA after quality reviews of submitted xevMPD data, offering several options for how these acknowledgments are processed. The latter half of the section shifts focus to future and upcoming structured data submission requirements. Questions 35 through 37 delve into initiatives and strategies companies are employing to prepare for these evolving mandates. The survey lists common strategies observed across the industry but also invites participants to share internally developed approaches, recognizing the unique challenges and solutions companies might devise. The video then highlights specific major initiatives: the EU IDMP SPOR initiative (Question 38) and UDEMED (Question 39). For these, the survey asks participants to estimate the number of months required to achieve full readiness for compliant submissions to the EMA, providing a range of timeframes for selection. The final questions, 40 and 41, address the anticipated costs associated with preparing for IDMP SPOR and UDEMED, respectively. These questions differentiate between costs already incurred and additional expected spend, specifying cost categories such as software, external consultants, external service providers, and data remediation/migration, while explicitly excluding internal resource costs to ensure consistent data comparison. Participants are also asked to indicate their level of confidence in future cost estimates. Key Takeaways: * **Criticality of Structured Data Submissions:** The video underscores the ongoing and increasing importance of structured data submissions for regulatory compliance in the pharmaceutical and life sciences sectors, particularly with mandates from bodies like the EMA. * **Diverse Management Approaches:** Companies employ a variety of methods for managing existing structured data submissions, ranging from manual processes and internal tools to leveraging external vendors or direct interaction with Health Authority portals. Many organizations utilize a combination of these approaches. * **Specific Regulatory Focus on xevMPD:** The survey specifically investigates how companies handle xevMPD third acknowledgment records from the EMA, highlighting the granular detail required for managing post-submission regulatory feedback. * **Proactive Preparation for Future Mandates:** A significant portion of the survey is dedicated to understanding how companies are strategically preparing for upcoming structured data submission requirements, such as the EU IDMP SPOR initiative and UDEMED. * **Strategic Planning for Compliance:** Companies are encouraged to articulate their specific initiatives and strategies for future compliance, including internally developed approaches, indicating a need for tailored solutions beyond generic industry practices. * **Estimating Readiness Timeframes:** Organizations are asked to estimate the time (in months) required to achieve full readiness for compliant submissions to the EMA for major initiatives like IDMP SPOR and UDEMED, providing insight into project timelines and resource allocation. * **Comprehensive Cost Estimation:** The survey requires a detailed breakdown of anticipated costs for compliance, including software, external consultants, contractors, external service providers, and data remediation/migration. This provides a holistic view of financial investment. * **Exclusion of Internal Resource Costs:** To ensure data consistency across survey responses, companies are specifically instructed not to include internal resource costs in their budget estimates, allowing for clearer benchmarking of external expenditures. * **Tracking Current vs. Future Spend:** The survey distinguishes between dollars already spent and additional dollars expected to be spent, offering a phased view of financial commitment towards regulatory readiness. * **Confidence in Cost Estimates:** Participants are asked to provide a level of confidence (high, medium, low) for their future cost estimates, acknowledging the inherent uncertainty in projecting future expenditures for complex regulatory projects. * **Value of Aggregated Data:** The survey emphasizes that all collected data is blinded, encouraging companies to share sensitive budget and strategy information to contribute to valuable industry-wide benchmarks and insights. * **Evolving Regulatory Landscape:** The continuous introduction of new sections and questions in the World Class RIM survey reflects the dynamic and evolving nature of regulatory information management and compliance requirements. Key Concepts: * **Structured Data Submissions:** Data submitted to regulatory authorities in a predefined, machine-readable format to ensure consistency and facilitate processing. * **xevMPD:** Extended EudraVigilance Medicinal Product Dictionary, a database of medicinal product data in the European Union, managed by the EMA. * **EMA (European Medicines Agency):** The agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the European Union. * **EU IDMP SPOR Initiative:** The European Union's implementation of ISO Identification of Medicinal Products (IDMP) standards, focusing on Substances, Products, Organizations, and Referentials (SPOR) data. * **UDEMED:** The European Database on Medical Devices, a central database developed by the European Commission to enhance market surveillance and transparency for medical devices. * **Health Authority Portal:** Online platforms provided by regulatory bodies (like the EMA) for direct submission and management of regulatory data. * **Data Remediation and Migration:** Processes involved in correcting errors or inconsistencies in data and transferring data from one system or format to another, often a significant part of preparing for new regulatory requirements.
Aquila University The eCTD Publishing Process
Aquila Solutions
/@aquilasolutions6783
Jan 17, 2020
This video explores the intricate and often underestimated eCTD (Electronic Common Technical Document) publishing process, which is critical for regulatory submissions like NDAs to agencies such as the FDA. The speaker highlights the common misconception among sponsors regarding the time and resources required to convert years of clinical data into a compliant and reviewable eCTD, emphasizing that inadequate planning significantly increases project risk. The discussion details the essential components for eCTD creation, including specialized publishing systems, advanced PDF tools, eCTD validators, and a dedicated team of experienced regulatory operations publishers. The process is broken down into four major activities: lifecycle planning, document remediation, quality control, and project management, with remediation consuming the vast majority of the effort. Key Takeaways: * **Underestimated Complexity:** eCTD publishing is a highly complex, resource-intensive process, with sponsors frequently underestimating the 2,000 man-hours and minimum four months required for a typical 505 B1 NDA (100,000+ pages, 300+ documents). * **Critical Resource Requirements:** Successful eCTD publishing necessitates a robust technology stack (publishing system, advanced PDF tools, dual eCTD validators) and a skilled team comprising experienced manager-level and associate-level regulatory publishers. * **Remediation is King:** Document remediation, involving cleaning, formatting, bookmarking, and intricate linking of individual PDFs, accounts for approximately 70% of the total project time, underscoring its manual and meticulous nature. * **QC is Non-Negotiable:** Cutting corners on the 15% allocated for quality control introduces substantial risk of non-compliance, incorrect versions, broken links, or inconsistent content, which can severely impact reviewer satisfaction and approval chances. * **Operational Challenges:** Beyond document processing, significant challenges include managing large file transfers (often 10-20+ GB per submission, requiring multiple transfers) and ensuring seamless integration of new submissions with previous ones. * **Strategic Compliance:** Proper eCTD planning and execution are not just technical tasks but strategic imperatives that directly influence regulatory approval timelines and outcomes by ensuring a clear, consistent, and easily reviewable application for regulatory bodies.
Clinical Trials and Research News Weekly Roundup | 10-14-2019 S1 E14
To Be Frank
/@therealtobefrank
Oct 12, 2019
This video provides a weekly roundup of significant news in clinical trials and life sciences research, covering a broad spectrum of topics from vaccine development and new drug approvals to industry trends and technological advancements. A central theme is the increasing integration of technology, particularly Veeva's platforms and Artificial Intelligence, into pharmaceutical R&D and clinical operations. The discussion highlights both the opportunities and ethical challenges presented by these innovations within the regulated life sciences environment. Key Takeaways: * **Veeva's Strategic Expansion in Clinical Data Management:** Veeva is actively strengthening its position in clinical operations by offering SiteVault Free to investigator sites and showcasing its Vault CDMS for unified clinical data and document management. This indicates a growing market for specialized Veeva consulting and integration services * **Accelerated AI Adoption Across Pharma Value Chain:** The partnership between Novartis and Microsoft to leverage AI in drug development, clinical trials, manufacturing, and finance underscores the critical and expanding role of AI in the pharmaceutical industry. * **Robust Growth in Clinical Research and CRO Ecosystem:** The video highlights a thriving life sciences sector, evidenced by the increase in clinical trials and the launch of specialized Contract Research Organizations (CROs). * **Critical Importance of Data Ethics and Regulatory Compliance in AI:** The segment discussing the use of AI to analyze patient data (YouTube videos of children) without explicit consent brings to the forefront the ethical and regulatory complexities of deploying AI in research.g., GxP, 21 CFR Part 11). * **Innovation in Advanced Therapeutics:** News about Moderna's mRNA therapeutic and gene therapy trials demonstrates the ongoing push for novel treatment modalities, which often require sophisticated data infrastructure and AI-driven insights for efficient development, clinical management, and regulatory navigation.
Quality and Manufacturing Highlights: 2019 Veeva R&D Summit
Veeva Systems Inc
/@VeevaSystems
Sep 27, 2019
This video provides an in-depth exploration of quality and manufacturing highlights from the 2019 Veeva R&D Summit, focusing on the transformative projects undertaken by pharmaceutical and life sciences companies. Mike Jovanis, VP of Vault Quality at Veeva, and Kent Malmros, Senior Director of Vault Training, share key reflections on modernizing and unifying quality management systems and integrating training into this unified approach. The discussion highlights a historical context where early electronic quality projects, driven by the emergence of 21 CFR Part 11 in the late 1990s, led to a fragmented landscape of homegrown applications and manual processes, creating a strong impetus for comprehensive transformation. The presentation delves into several real-world case studies illustrating these transformative initiatives. Samsung Biologics, a contract manufacturing organization, was featured as a keynote speaker, showcasing their successful implementation of Veeva's suite of quality products to modernize their manufacturing environment. Similarly, BMS and Roche presented on their respective Quality Management System (QMS) transformation projects, both aiming to consolidate multiple legacy QMS applications into a single Veeva Vault QMS. BMS specifically focused on collapsing and harmonizing R&D quality with manufacturing quality, while Roche pursued harmonization and consolidation across various previously separate lines of business within their diagnostics sector. PRA Health Sciences, a Contract Research Organization (CRO), also shared their experience with a unification and harmonization project, integrating both Vault QualityDocs and Vault QMS through a multi-phase initiative to bring disparate solution spaces into a single Vault platform. Kent Malmros then transitions to the critical role of training within this unified quality framework, emphasizing the goal of avoiding the fragmentation issues that plagued document and quality management systems. The discussion centered on improving GxP and quality training effectiveness through unified training management. Foamix shared their journey, demonstrating how their maturation from using QualityDocs to a unified training system was a natural progression, enabling them to eliminate redundant training applications and integrations. Dicerna further elaborated on achieving efficiency and effectiveness across the end-to-end lifecycle of document creation and subsequent training program development within the same application, seamlessly managing curriculum review, approval, assignment delivery, and progress tracking. Finally, Xeris and Xencor, in a panel discussion, echoed these sentiments, highlighting the strategic advantage of a unified training approach to analyze training effectiveness by combining training outcome data with other quality event data. Key Takeaways: * **Addressing Fragmented Quality Landscapes:** The pharmaceutical industry has historically suffered from an "aging fragmented solution landscape" in quality management, stemming from early electronic implementations driven by 21 CFR Part 11, which necessitates transformative projects to unify and modernize systems. * **Strategic QMS Transformation:** Companies like BMS and Roche are undertaking significant QMS transformation initiatives to consolidate multiple legacy applications into a single, unified platform (Veeva Vault QMS), leading to improved efficiency and compliance. * **Harmonization Across Business Functions:** Beyond consolidation, harmonization of quality processes across different business units, such as R&D quality with manufacturing quality (BMS) or across various lines of business (Roche), is crucial for operational consistency and regulatory adherence. * **Unified Training Management for GxP:** Effective GxP and quality training is a cornerstone of regulatory compliance. Implementing a unified training management system, such as Veeva Vault Training, helps avoid the integration complexities and inefficiencies of disparate training applications. * **End-to-End Training Lifecycle Management:** Modern unified training systems enable seamless management of the entire training lifecycle, from document creation and curriculum development to assignment delivery, progress tracking, and review/approval, all within a single application. * **Measuring Training Effectiveness:** A key advancement is the ability to combine training outcome data with other quality event data to robustly demonstrate the effectiveness of training programs, moving beyond simple completion tracking to actual impact assessment. * **Benefits for Contract Research Organizations (CROs):** CROs like PRA Health Sciences benefit significantly from unifying quality documentation (Vault QualityDocs) and QMS (Vault QMS) into a single platform, streamlining operations and ensuring consistent quality across research phases. * **The Transformative Nature of Modern Quality Projects:** Current quality projects are not merely about replacing old systems but about fundamentally transforming how quality is managed, leading to more integrated, efficient, and compliant operations. * **Leveraging Integrated Suites:** Adopting a comprehensive suite of quality products, such as those offered by Veeva Vault, allows companies to mature their quality processes naturally, moving from document management to integrated training and QMS, thereby eliminating redundant applications and integrations. * **Proactive Compliance:** The shift towards unified systems allows companies to proactively manage compliance challenges rather than reactively remediating them, as was often the case with older, fragmented systems. Tools/Resources Mentioned: * Veeva Vault Quality * Veeva Vault QMS * Veeva Vault QualityDocs * Veeva Vault Training Key Concepts: * **21 CFR Part 11:** Regulations concerning electronic records and electronic signatures for the pharmaceutical industry, which historically drove the initial adoption of electronic quality systems. * **GxP (Good Practices):** A collection of quality guidelines and regulations ensuring that products are safe and meet their intended use, encompassing areas like Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP). * **QMS (Quality Management System):** A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives, crucial for regulatory compliance in life sciences. * **Unified Training Management:** An integrated approach to managing all aspects of employee training, particularly GxP and quality-related training, within a single system to ensure consistency, efficiency, and compliance. * **Quality Event Data:** Data related to quality incidents, deviations, CAPAs (Corrective and Preventive Actions), and other quality-related occurrences, which can be analyzed to identify trends and improve processes. * **Harmonization:** The process of making different systems, processes, or standards consistent and compatible across various departments, sites, or lines of business within an organization. Examples/Case Studies: * **Samsung Biologics (Contract Manufacturing):** Implemented Veeva quality products to modernize their manufacturing environment. * **BMS (Biopharmaceutical):** Consolidated multiple legacy QMS apps into a single Vault QMS and harmonized R&D quality with manufacturing quality. * **Roche (Pharmaceutical/Diagnostics):** Harmonized and consolidated QMS across various different lines of business that were previously separate systems. * **PRA Health Sciences (Contract Research Organization - CRO):** Implemented Vault QualityDocs and Vault QMS in a three-phase initiative to unify and modernize their quality solution spaces. * **Foamix (Pharmaceutical):** Shared their story of maturing from QualityDocs to a unified training system, eliminating training applications and integrations. * **Dicerna (Biopharmaceutical):** Discussed efficiency and effectiveness in managing the end-to-end lifecycle of creating documents and developing training programs within the same application. * **Xeris (Pharmaceutical) & Xencor (Biopharmaceutical):** Shared insights on leveraging a unified training approach to combine training outcome data with other quality event data to demonstrate training effectiveness.