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4:45

Vault Submissions Archive Demo

Veeva Systems Inc

/@VeevaSystems

Feb 26, 2024

This video provides an in-depth demonstration of Veeva Vault Submissions Archive, a component of the Vault RIM (Regulatory Information Management) Suite, designed to serve as a validated, centralized, cloud-based repository for accessing the complete history of regulatory submissions and health authority interactions globally. The core purpose of the application is to enable faster, more accurate interactions with health authorities by providing a single source of truth for all published outputs, including eCTD and non-eCTD formats (such as NCE, eAEU, and paper submissions). The presenter, a solution consultant, emphasizes the application's global capabilities, requiring no local software installation, and its adherence to stringent regulatory standards, specifically 21 CFR Part 11 and EU GMP Annex 11 requirements. The demonstration focuses heavily on the user experience for navigating and retrieving specific regulatory content. The starting point is the Dossier Viewer, where users can select a specific application (e.g., an annual DCP application) and then refine the view using powerful filtering capabilities. Users can filter by sequence number, status, submission type, and actual submission date. A key feature highlighted is the advanced filtering, which allows users to search across metadata associated with the documents. For instance, the consultant demonstrates finding all sequences and associated documents where a specific manufacturer (Veeva from Brussels) has been published, quickly identifying the relevant sequences (5 and 6). Once a sequence is selected, users can visualize all associated documents, view lifecycle information, and open the actual document within the built-in viewer. The true value proposition of Vault Submissions Archive, as articulated in the demo, lies in the connection between documents and data on the same platform. The built-in viewer not only displays the document content but also provides the associated metadata on the right side and the table of contents on the left, allowing for seamless navigation without returning to the main navigator. Furthermore, users can directly open the application record from the document view to see detailed background information. This integrated approach allows the platform to be used not just for archiving, but also for the planning and tracking of regulatory objectives and submissions, enabling users to manage dates and statuses effectively. Finally, the demonstration concludes by showcasing the powerful reporting and dashboard capabilities inherent in the Vault platform. Vault Submissions Archive allows users to report on any data or documents stored within the system. A specific example, the "Application Chronology" dashboard, is presented as a valuable tool. This dashboard visually tracks the chronological progression of an application over time, including submitted and planned sequences, approved or pending regulatory objectives, and all health authority interactions, such as commitments and correspondence. This comprehensive view ensures that the archive functions as an authoritative source for submissions, correspondence, and regulatory planning. Key Takeaways: • **Centralized Global Repository:** Vault Submissions Archive provides a single, cloud-based repository for all regulatory filings and health authority interactions worldwide, eliminating the need for local software and facilitating global sharing of submission history across the organization. • **Comprehensive Format Support:** The platform supports both eCTD (electronic Common Technical Document) and various non-eCTD electronic formats (NCE, eAEU) and even paper submissions, ensuring a complete historical record regardless of the original submission type. • **Regulatory Compliance Assurance:** The application is built to comply strictly with critical regulatory requirements, specifically 21 CFR Part 11 (governing electronic records and signatures in the US) and EU GMP Annex 11, ensuring the validated environment necessary for life sciences operations. • **Advanced Search and Filtering:** Users can quickly locate specific content using powerful search capabilities combined with filters based on status, submission type, date, and sequence, including advanced filtering that queries document metadata (e.g., searching by manufacturer name). • **Integrated Dossier Viewer:** A built-in viewer allows users to navigate the dossier easily in current, sequential, or cumulative views, providing immediate access to the content, associated metadata, and the table of contents simultaneously. • **Connected Data Model:** The platform connects documents and underlying data (metadata) on the same platform, allowing users to seamlessly transition from viewing a document to accessing the detailed record of the associated application for context and planning. • **Regulatory Planning and Tracking:** Beyond archiving, the system serves as a tool for managing regulatory objectives, allowing teams to track submission dates, statuses, and commitments directly within the same environment where the submission history resides. • **Actionable Business Intelligence:** The platform includes robust reporting capabilities, exemplified by the "Application Chronology" dashboard, which provides a chronological, visual representation of application progress, submitted sequences, regulatory objective approvals, and health authority correspondence. • **Dynamic Access Control:** Published outputs are stored securely with dynamic access controls, ensuring that only personnel with the appropriate permissions can view specific content, maintaining data integrity and confidentiality. • **Streamlined Health Authority Interactions:** By providing an authoritative, easily searchable source for all submissions and correspondence, the archive enables faster and more accurate responses and interactions with regulatory bodies globally. Tools/Resources Mentioned: * Veeva Vault Submissions Archive * Veeva Vault RIM Suite * eCTD (electronic Common Technical Document) Key Concepts: * **21 CFR Part 11:** US FDA regulation governing electronic records and electronic signatures, ensuring their trustworthiness and reliability. Vault Submissions Archive is explicitly compliant with this standard. * **EU GMP Annex 11:** European Union guideline concerning computerized systems used in regulated GxP environments. The platform ensures compliance with this standard. * **Dossier Viewer:** The primary interface within the application used to view and navigate the complete set of published outputs (dossiers) for a specific application. * **Application Chronology:** A specific business intelligence dashboard that visually tracks the timeline of an application, including sequences submitted, regulatory objectives, and health authority interactions. * **Health Authority Interactions:** Refers to all formal communications, commitments, and correspondence exchanged between the pharmaceutical company and regulatory bodies like the FDA or EMA.

1.8K views

20.2

SubmissionsVaultHealth Authorities

9:21

Press Ganey Patient Satisfaction Scores Explained

AHealthcareZ - Healthcare Finance Explained

@ahealthcarez

Feb 25, 2024

This video provides an in-depth explanation of Press Ganey patient satisfaction scores, a critical metric within the U.S. healthcare system. Dr. Eric Bricker, the speaker, begins by establishing Press Ganey as a prominent American company that has been surveying patients about their healthcare experiences for 38 years. He emphasizes that understanding Press Ganey scores is essential for anyone working in healthcare, including those in the pharmaceutical industry, hospital administration, and employee benefits. Over 50% of U.S. hospital systems utilize Press Ganey to measure patient satisfaction with their physicians, and the company has relationships with over 41,000 healthcare facilities, making it the largest patient survey organization in the country. The video delves into the specific methodology of Press Ganey surveys, focusing on the 10 questions asked about individual physicians after a patient visit. These questions cover aspects such as friendliness, clarity of explanation, concern for the patient, inclusion in decision-making, medication information, follow-up plans, speech clarity, time spent, confidence in the doctor, and whether the patient would recommend the doctor. Crucially, Dr. Bricker highlights the unique scoring system: each question is rated on a one-to-five scale (very poor to very good), but only "very good" (a score of five) responses count towards the doctor's official Press Ganey score. The final score is presented as a percentage of "very good" responses out of the total. For a doctor to receive a score, a minimum of 30 patient surveys are required, meaning 300 individual responses across the 10 questions. Dr. Bricker presents compelling data illustrating that patient satisfaction with doctors is overwhelmingly high. Even physicians in the bottom 10th percentile of scores still receive a "very good" rating on 70% of responses, while top 10th percentile doctors score 91% "very good," and the median is 82%. This narrow range and consistently high scores across all specialties (e.g., dermatology, OBGYN, surgery, oncology) lead to three major implications. First, healthcare providers and hospitals cannot effectively compete on patient satisfaction because nearly all patients are highly satisfied with their doctors. Competition, therefore, must shift to factors like access to appointments or out-of-pocket costs. Second, it is futile to attempt to pit patients against their doctors, as patients overwhelmingly like and trust their physicians. Third, and most significantly, doctors serve as the most effective conduit for any healthcare initiative aimed at patients, given their strong bond and influence, surpassing that of insurance companies, employers, or the government. Key Takeaways: * **Press Ganey's Dominance in Patient Surveys:** Press Ganey is a leading American company, used by over 50% of U.S. hospital systems and connected to over 41,000 healthcare facilities, making its patient satisfaction scores a ubiquitous and essential metric in healthcare. * **Physician-Specific Survey Questions:** Press Ganey surveys include 10 specific questions about a doctor's performance, covering aspects like friendliness, clarity of explanation, empathy, patient involvement in decision-making, medication information, follow-up plans, communication clarity, time spent, patient confidence, and willingness to recommend. * **Unique "Top Box" Scoring Methodology:** The most critical aspect of Press Ganey scoring is that only the highest rating ("very good" or a 5 out of 5) counts towards a physician's score. Any rating from "very poor" to "good" (1-4) does not contribute positively to the final percentage. * **Universally High Patient Satisfaction:** Patient satisfaction with doctors is remarkably high across the board. Even physicians in the bottom 10th percentile of scores receive a "very good" rating on 70% of responses, while the median score is 82%, and top 10th percentile doctors achieve 91%. * **Inability to Compete on Satisfaction:** Given the uniformly high patient satisfaction scores across all physicians and specialties, hospitals and individual doctors cannot differentiate or compete effectively based on patient satisfaction alone. * **Alternative Competitive Differentiators:** Instead of satisfaction, healthcare providers should focus on competing in areas such as patient access (ease of getting appointments) and out-of-pocket costs, as these are factors where patients perceive significant differences and value. * **Strong Patient-Physician Bond:** Patients exhibit a strong, positive bond with their doctors, making it ineffective and counterproductive for other entities (like insurance companies or employers) to attempt to create friction or pit patients against their physicians. * **Physicians as the Primary Conduit:** Doctors are the most trusted and influential conduit for reaching and influencing patients. Any initiative or message intended for plan members or employees and their families should ideally be channeled through their physicians to maximize impact and acceptance. * **Consistency Across Specialties:** The high and narrow range of patient satisfaction scores holds true across all medical specialties, indicating a widespread positive perception of doctors regardless of their area of practice. * **Minimum Survey Threshold:** A physician requires a minimum of 30 patient surveys (totaling 300 individual responses across 10 questions) to generate an official Press Ganey score. * **Implications for Pharmaceutical and Life Sciences:** Understanding the physician's role as the primary conduit for patient influence is crucial for pharmaceutical and medical device companies in developing effective commercial operations, marketing strategies, and patient engagement programs. Solutions that empower or leverage the physician-patient relationship will likely be more impactful. **Tools/Resources Mentioned:** * **Press Ganey:** The company providing patient satisfaction surveys. * **AHealthcareZ.com:** The website for the channel, offering healthcare finance educational videos and a newsletter. * **"16 Lessons in the Business of Healing":** A book by Dr. Eric Bricker, the speaker. **Key Concepts:** * **Press Ganey Patient Satisfaction Scores:** A standardized metric used widely in U.S. healthcare to measure patient experiences and satisfaction with physicians and facilities. * **Top Box Scoring:** A specific scoring methodology where only the highest possible rating (e.g., "very good" or 5 out of 5) is counted towards a positive score, effectively setting a very high bar for satisfaction. * **Conduit:** In this context, referring to physicians as the primary and most trusted channel through which healthcare information, initiatives, and influence can effectively reach patients.

6.3K views

34.7

10:05

Veeva Vault RIM Submission Archiving Overview : How Vault Submission Archive Works

Anitech Talk

/@AnitechTalk

Feb 23, 2024

This video provides an in-depth exploration of Veeva Vault RIM's Submission Archiving features, detailing how regulatory professionals can effectively manage and access published regulatory submissions. The speaker, an expert in Veeva systems, outlines the core functionalities of the Submission Archive, emphasizing its role as a global repository for documents submitted to health authorities worldwide. The presentation begins by establishing the context of submission archiving within the broader Veeva RIM suite, building upon previous discussions of submission publishing and regulatory registrations. The core of the discussion revolves around the capabilities of Veeva Vault RIM Submission Archive, which is designed to import, archive, and facilitate the viewing of published submissions in a structured manner. This includes support for both eCTD (electronic Common Technical Document) and non-eCTD formats, ensuring comprehensive coverage for various regulatory requirements. The speaker highlights how the system provides a secure and globally accessible platform for regulatory users to review published outputs that were sent to health authorities, complete with dynamic access controls to ensure data security and compliance. An integrated eCTD viewer is presented as a key feature, allowing for quick review of content across applications and submissions, and providing contextual information on how content was reused across different regulatory filings. Further detailing the system's utility, the video delves into specific features such as purpose-built import and export functionalities, the integrated eCTD submission viewer, and PDF link navigation. The import function allows for the ingestion of dossier data in both eCTD and non-eCTD formats, while the export feature enables users to extract dossier data with the same structured folder hierarchy, facilitating reuse for other regions or purposes. The integrated viewer provides a structured display of published documents, often converted to PDF, with navigable links for seamless review of content, metadata, and historical changes. Additionally, the video introduces the built-in dashboard and reporting capabilities, specifically mentioning the "Application Chronology" report, which offers a consolidated view of submissions, regulatory objectives, commitments, and correspondence documents, enhancing oversight and strategic planning for regulatory teams. The session concludes by briefly touching upon the concept of "archive correspondence," which includes critical communication documents like approval letters and meeting minutes exchanged with health authorities. Key Takeaways: * **Centralized Regulatory Submission Repository:** Veeva Vault RIM Submission Archive serves as a global, secure hub for importing, archiving, and viewing all published regulatory submissions sent to health authorities, supporting both eCTD and non-eCTD formats. * **Structured Access to Published Outputs:** The system ensures that published outputs are viewable in a proper, structured way, allowing regulatory users to easily access and review documents that have already been submitted. * **Dynamic Access Control and Security:** Robust security features, including dynamic access control, are integrated to ensure that only authorized users can view specific published documents, maintaining data integrity and regulatory compliance. * **Integrated eCTD Viewer for Comprehensive Review:** An integrated eCTD viewer allows for quick and efficient review of content across various applications and submissions, providing insights into content reuse and submission context. * **Purpose-Built Import and Export Functionality:** The system offers dedicated features for importing dossier data (eCTD and non-eCTD) and exporting it while maintaining the original folder structure, which is crucial for leveraging submissions across different regions. * **PDF Link Navigation for Enhanced Usability:** Published documents are often converted to PDF format with generated links, enabling users to easily navigate between related documents, review metadata, and track content history. * **Built-in Reporting and Dashboards:** Veeva Vault RIM includes powerful reporting capabilities, such as the "Application Chronology" report, which provides a consolidated view of submissions, regulatory objectives, commitments, and correspondence for better oversight. * **Management of Archive Correspondence:** The system archives critical communication documents, referred to as "archive correspondence," which includes approval letters, meeting minutes, telephone contacts, and email acknowledgements from health authority interactions. * **Facilitates Global Accessibility:** Submissions and their published outputs are accessible by authorized users anywhere across the globe, streamlining international regulatory operations and collaboration. * **Supports Regulatory Compliance:** By providing a structured, secure, and auditable archive of regulatory submissions and communications, the system significantly aids in maintaining regulatory compliance with bodies like the FDA and EMA. Tools/Resources Mentioned: * Veeva Vault RIM (Regulatory Information Management) * Veeva Vault Submission Archive * eCTD Viewer Key Concepts: * **Submission Archiving:** The process of securely storing and managing published regulatory submissions and their associated documents after they have been sent to health authorities. * **eCTD (electronic Common Technical Document):** A standard format for electronically submitting applications, amendments, supplements, and reports to regulatory authorities, particularly in the pharmaceutical industry. * **Archive Correspondence:** Communication documents exchanged with health authorities during the submission process, such as approval letters, meeting minutes, telephone contacts, and acknowledgement emails, which are stored for historical record and compliance. * **Application Chronology Report:** A built-in report within Veeva Vault RIM that provides a chronological overview of an application's regulatory activities, including submissions, regulatory objectives, commitments, and correspondence.

1.3K views

41.2

#Veeva#Submission#FDA

3:06

Radical Transparency Ep 13 - Steps For Efficient Salesforce to Veeva Vault Migration

CapStorm

/@CapstormSoftware

Feb 22, 2024

This video provides an in-depth exploration of the technical challenges and recommended steps for efficiently migrating data from the Salesforce platform to Veeva Vault, a critical process spurred by Veeva’s separation from Salesforce. The speaker, Ted Papis, CEO of CapStorm, frames the discussion around the necessity of maintaining "radical transparency" and ensuring "equal education" within the Salesforce community regarding off-platform data management. The core controversy addressed is the public understanding that Veeva's native migration path may not guarantee 100% referential integrity when copying data from the Salesforce/Force.com platform, necessitating a robust, third-party methodology for high-stakes data migration in the Healthcare and Life Sciences (HCLS) sector. The proposed methodology centers on utilizing an intermediate, off-platform database layer to ensure data fidelity and facilitate necessary transformations. The first crucial step involves executing a complete backup of the Salesforce data, extracting it from the Force.com platform with full referential integrity. This process creates a 100% carbon copy of the data, metadata, and all inter-relationships, typically housed within a SQL Server database schema. This intermediate SQL layer is essential because it allows for complex data transformation and cleansing to occur outside of the proprietary Salesforce environment, providing flexibility and control over the migration process. Once the data model resides in the SQL Server database, the subsequent steps become significantly simplified. The data model is then exposed to the import tools or APIs of Veeva Vault. The speaker advocates for the use of specialized software, such as the CopyStorm application, to automate the movement of this transformed data from the SQL Server database into Veeva Vault. The emphasis on full automation is a key takeaway, as it eliminates human intervention, which the speaker directly correlates with errors. This fully robotic, four-step process—from Force.com to SQL Server, transformed at the SQL layer, and then imported to Veeva Vault—is presented as the most reliable path to achieving a complete and accurate migration. The overall approach is a technical blueprint designed to mitigate the risks associated with data loss or corruption during a major platform transition. For companies in the life sciences sector managing highly regulated data, ensuring 100% referential integrity is non-negotiable. The methodology provides a clear, structured framework for managing the complexities of differing data models between Salesforce and Veeva Vault, ensuring that all relationships between records remain intact, which is vital for compliance and operational continuity. Key Takeaways: • **Veeva Migration Integrity Warning:** The publicly available reference documentation suggests that Veeva’s native migration path may not copy data with 100% referential integrity from Salesforce, posing a significant risk for regulated industries like Life Sciences. • **Necessity of Off-Platform Backup:** The foundational step for any efficient migration is securing a complete, off-platform backup of all Salesforce data, including metadata and relationships, to ensure data safety and availability outside the source platform. • **SQL Server as the Transformation Hub:** Utilizing an intermediate SQL Server database is the recommended best practice for complex migrations, allowing the data model to be fully extracted and housed with 100% referential integrity before moving to the target system. • **Transformation at the SQL Layer:** All necessary data transformations, cleansing, and mapping required to align the Salesforce data model with the Veeva Vault data model should be executed within the controlled SQL Server environment, maximizing efficiency and minimizing errors. • **Automation is Critical for Accuracy:** The migration process from the SQL layer to Veeva Vault must be 100% automated (robot-driven) using APIs or import tools, as human intervention introduces the highest risk of errors and inconsistencies. • **Four-Step Migration Blueprint:** The recommended technical path involves (1) Data extraction from Force.com, (2) Storage in SQL Server with full integrity, (3) Transformation at the SQL layer, and (4) Automated import into Veeva Vault. • **Target Audience Focus:** The discussion is highly relevant to Healthcare and Life Sciences (HCLS) companies currently facing the operational challenge of migrating regulated data following the announced separation of Veeva from the Salesforce platform. • **Data Integrity Definition:** Achieving 100% referential integrity means ensuring that every relationship between data points (e.g., a contact linked to an account, linked to a clinical trial record) remains intact and accurate in the new Veeva Vault environment. • **Data Model Exposure:** Once transformations are complete in SQL, the data model must be structured and exposed in a format that is readily consumable by Veeva Vault’s native import tools or APIs for seamless ingestion. Tools/Resources Mentioned: * **Salesforce/Force.com Platform:** The source system for the data migration. * **Veeva Vault:** The target system for the migrated data. * **SQL Server Database:** The recommended intermediate platform for data staging and transformation. * **CopyStorm Application:** A specific software mentioned by the speaker's company (CapStorm) designed to automate the data movement from SQL Server into Vault. Key Concepts: * **Referential Integrity:** The property ensuring that all relationships between records are maintained and valid across the migration, crucial for regulated data where audit trails and linkages must be preserved. * **Off-Platform Backup:** The practice of extracting a complete copy of data, metadata, and relationships from the SaaS platform (Salesforce) and storing it in a separate, controlled environment (like SQL Server). * **Automated Migration:** Using software and APIs, rather than manual processes, to execute the data transfer, thereby eliminating human error and ensuring consistency across large datasets.

40 views

21.1

14:48

Vikas Singh

/@VikasSinghPharmalive

Feb 15, 2024

This video announces a free, comprehensive online course designed to educate individuals on the role of an eTMF (electronic Trial Master File) Specialist. The course aims to provide a complete understanding of TMF and eTMF, catering to those with limited prior knowledge or individuals considering a career in this specialized area within clinical research. The speaker emphasizes the practical utility of the course, promising to cover fundamental concepts, regulatory requirements, and practical demonstrations essential for managing trial master files effectively. The curriculum for this course is structured to cover a wide array of topics, beginning with the foundational distinction between a traditional TMF and an eTMF, and elucidating the reasons behind the transition to electronic systems. It delves into critical basic concepts such as Good Documentation Practice (ALCOA), the development of an eTMF Plan, understanding the TMF Index (Configuration Manual), and the widely recognized TMF Reference Model. The course will also address quality control mechanisms, the significance of events and milestones in TMF management, and how to assess "TMF Health" based on completeness, timeliness, and quality review criteria. Further, the course will explore a risk-based approach to TMF management, a crucial methodology for efficient and compliant clinical trials. It will detail the essential documents required in a clinical trial and provide an overview of current regulations governing TMFs, which is vital for maintaining compliance. A significant portion of the course will focus on the practical aspects of an eTMF specialist's job responsibilities and career scope, culminating in a practical demonstration of how an eTMF specialist reviews and finalizes documents. The series concludes with a Q&A session, ensuring a holistic learning experience for participants. Key Takeaways: * **Foundational Understanding of TMF and eTMF:** The course will thoroughly explain what a Trial Master File (TMF) is and the specific advantages and functionalities of an electronic Trial Master File (eTMF), highlighting the industry's shift towards digital documentation. * **Good Documentation Practice (ALCOA):** A core principle of the course is ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate), which represents the fundamental standards for maintaining high-quality and compliant documentation in clinical research. * **Structured TMF Management Frameworks:** Participants will learn about establishing an eTMF Plan, utilizing a TMF Index (Configuration Manual) for organization, and adhering to the TMF Reference Model, a globally accepted standard for TMF structure and content. * **Assessing TMF Health:** The course outlines key criteria for evaluating the "health" of a TMF, focusing on its completeness (all required documents are present), timeliness (documents are filed promptly), and overall quality (accuracy and adherence to standards). * **Risk-Based Approach to TMF:** A critical methodology discussed is the application of a risk-based approach to TMF management, enabling professionals to prioritize efforts and resources on areas of higher risk to ensure compliance and data integrity. * **Essential Clinical Trial Documents:** The curriculum includes a detailed overview of the essential documents required throughout the lifecycle of a clinical trial, from study initiation to close-out, and their significance in regulatory submissions and audits. * **Current Regulatory Landscape:** The course will cover the prevailing regulations that govern TMFs, emphasizing the importance of compliance with national and international guidelines (e.g., FDA, EMA, ICH-GCP) to ensure the validity and integrity of clinical trial data. * **Practical Application and Job Responsibilities:** A significant component is the practical demonstration of an eTMF specialist's daily tasks, including document review and finalization processes, providing real-world insights into the role. * **Career Scope and Opportunities:** The course is explicitly designed for individuals considering a career as an eTMF specialist, offering insights into job responsibilities, career growth, and the overall scope within the clinical research industry. * **Comprehensive Learning Structure:** The course is organized into distinct modules (A-H), covering everything from basic definitions to practical skills and regulatory compliance, ensuring a structured and progressive learning path. **Key Concepts:** * **Trial Master File (TMF):** A collection of essential documents that individually and collectively permit the reconstruction of the conduct of a clinical trial and the evaluation of the quality of the data produced. * **Electronic Trial Master File (eTMF):** A digital system for managing and storing TMF documents, offering advantages in accessibility, searchability, security, and compliance over paper-based systems. * **ALCOA:** An acronym for Attributable, Legible, Contemporaneous, Original, Accurate – fundamental principles for good documentation practice in regulated environments. * **TMF Reference Model:** A standardized, hierarchical model for the content and structure of a TMF, developed by the Drug Information Association (DIA), to promote consistency and efficiency across clinical trials. * **TMF Health:** A concept referring to the overall quality, completeness, and timeliness of the TMF, crucial for audit readiness and regulatory compliance. * **Risk-Based Approach:** A strategy in TMF management where resources and efforts are allocated based on the potential risks associated with specific documents or processes, optimizing efficiency while maintaining compliance. * **Essential Documents:** Specific documents required by regulatory authorities and ICH-GCP guidelines to be maintained in the TMF, providing evidence of the trial's conduct and data integrity.

1.0K views

32.4

0:57

Omnichannel in Pharma. Veeva vs Salesforce

showerthinking

/@showerthinking

Feb 15, 2024

This video addresses the critical strategic decision currently facing pharmaceutical companies regarding their commercial technology infrastructure, specifically the ongoing platform divergence between Veeva Systems and Salesforce. The central discussion revolves around the future of Omnichannel engagement in the life sciences sector, following Veeva’s announcement a year prior that it would separate from the underlying Salesforce platform. This separation mandates that customers evaluate their long-term CRM and digital marketing strategy, particularly as major platform contract decisions are anticipated around 2025. The core tension highlighted is the competitive landscape for Omnichannel solutions. Salesforce is positioned as a recognized industry leader in this domain, leveraging its established Marketing Cloud platform, which is often considered a benchmark for digital engagement execution. In contrast, Veeva has committed to developing its own proprietary Omnichannel platform, with development slated for 2024. This timeline and approach are generating significant industry discussion because, for modern pharmaceutical commercial operations, the seamless, robust integration between the core CRM system and the digital Omnichannel platform is viewed as a non-negotiable requirement for effective customer engagement and compliance tracking. The speaker emphasizes the uncertainty created by this platform split. While Salesforce is aggressively promoting its specialized Life Sciences Cloud solution, Veeva has yet to fully clarify the specifics and maturity of its future Omnichannel offering. This lack of clarity forces clients to weigh the benefits of Veeva’s deep industry specialization against the proven, mature Omnichannel capabilities offered by Salesforce’s ecosystem. For firms specializing in system integration and AI solutions, like IntuitionLabs.ai, this platform divergence represents a major opportunity to advise clients on managing the complexity of multi-vendor environments, ensuring data integrity, and building compliant data pipelines regardless of the chosen core platform. The video serves as a prompt to the audience, soliciting opinions on how this platform divergence will impact future digital strategy and investment decisions in the regulated pharmaceutical sector. Key Takeaways: • **The 2025 Strategic Crossroads:** Pharmaceutical companies are approaching a critical technology decision point around 2025, driven by the contractual separation of Veeva from the Salesforce platform, necessitating a choice between two distinct commercial ecosystems. • **Mandatory CRM-Omnichannel Integration:** The industry considers tight, seamless integration between the foundational CRM system (Veeva or Salesforce Health Cloud) and the digital Omnichannel execution platform (e.g., Marketing Cloud) as essential for delivering personalized, compliant customer experiences. • **Salesforce’s Omnichannel Maturity Advantage:** Salesforce maintains a significant advantage in the Omnichannel space due to the maturity and widespread adoption of its Marketing Cloud, which offers established tools for campaign management, segmentation, and digital execution. • **Veeva’s Proprietary Platform Risk:** Veeva’s commitment to building its own Omnichannel platform introduces uncertainty regarding its time-to-market, feature set, and ability to achieve the same level of integration robustness as existing, mature solutions in the short term. • **Integration Complexity for Consultants:** The platform split guarantees increased complexity in data engineering and system integration, requiring specialized consulting expertise to ensure unified data flow, accurate reporting, and compliance across disparate systems. • **Impact on AI and LLM Solutions:** The choice of the core platform directly affects the deployment of advanced AI and LLM solutions (like Generative AI Sales Ops Assistants), which rely heavily on clean, unified customer interaction data sourced from both the CRM and the Omnichannel system. • **Evaluating Total Cost of Ownership (TCO):** Companies must analyze the TCO beyond licensing, factoring in the cost of integration development, maintenance of custom APIs, and the potential need for specialized data engineering services to bridge the gap between Veeva CRM and third-party marketing clouds. • **Salesforce’s Unified Pitch:** Salesforce is leveraging this separation by promoting its Life Sciences Cloud as a unified platform solution, appealing to companies that prefer a single-vendor approach for CRM, commercial operations, and digital marketing. • **The Compliance Challenge:** Any platform migration or integration project must prioritize regulatory compliance (FDA, GxP, 21 CFR Part 11), ensuring that all customer interactions and audit trails are accurately captured and managed, regardless of which vendor handles the digital execution. Tools/Resources Mentioned: * Veeva Systems * Salesforce * Salesforce Health Science Cloud * Salesforce Marketing Cloud Key Concepts: * **Omnichannel in Pharma:** The strategy of delivering consistent, personalized, and compliant customer experiences across all available channels (digital, field force, medical affairs) using integrated technology platforms. * **CRM-Digital Platform Integration:** The necessary technological link between the core Customer Relationship Management system (which stores customer master data and interaction history) and the digital marketing platform (which executes email, web, and other digital campaigns). This integration is crucial for closed-loop marketing and compliance in life sciences.

TrackWise Software in Pharma l TrackWise in Pharmaceutical industry Interview question and answers

PharmGrow

/@PharmGrow

Feb 13, 2024

This video provides an in-depth exploration of TrackWise software, a widely used Quality Management System (QMS) in the pharmaceutical industry. Presented in an interview question-and-answer format, the content systematically addresses the functionalities, advantages, regulatory implications, and integration capabilities of TrackWise. The primary purpose is to educate viewers on how TrackWise supports quality management and regulatory compliance within the highly regulated pharmaceutical sector, offering insights into its practical applications and benefits over traditional paper-based systems. The discussion begins by defining TrackWise as a critical software for managing various quality-related processes, including deviations, Corrective and Preventive Actions (CAPAs), change controls, market complaints, audits, and supplier quality management. It also highlights its utility in broader areas such as regulatory compliance, risk management, document management, and training management. A significant portion of the video is dedicated to outlining the ten key advantages of TrackWise, such as centralized data management, improved accessibility, real-time updates, enhanced security, efficient document retrieval, automated workflows, integration with other systems, comprehensive reporting, trending capabilities, and robust regulatory compliance support. The video further delves into how TrackWise specifically aids in regulatory adherence, emphasizing its role in facilitating documentation, reporting, and generating essential audit trails required by bodies like the FDA. It details how the software manages deviations in manufacturing through configurable workflows and automated notifications, ensuring prompt investigation and resolution. A crucial theme is data integrity and compliance with regulations like 21 CFR Part 11, which TrackWise addresses through features like electronic signatures, comprehensive audit trails, and stringent data security measures. The discussion concludes by covering practical aspects such as device accessibility, security protocols, the significance of electronic signatures, inter-departmental collaboration, workflow customization, common industry uses, and its ability to integrate with other enterprise systems like ERP, LIMS, and EDMS. Key Takeaways: * **Comprehensive Quality Management:** TrackWise serves as a centralized platform for managing a wide array of quality events and processes within the pharmaceutical industry, including deviations, CAPAs, change controls, market complaints, audits, and supplier quality management. * **Enhanced Regulatory Compliance:** The software is instrumental in helping pharmaceutical companies meet stringent regulatory requirements from bodies like the FDA by providing robust documentation, reporting, and audit trail capabilities. * **Superior to Paper-Based Systems:** TrackWise offers significant advantages over traditional paper-based QMS, including centralized data management, real-time updates, improved accessibility, enhanced security, and efficient document retrieval. * **Automated Workflows and Efficiency:** It streamlines quality processes through automated workflows, reducing manual effort, minimizing errors, and ensuring timely execution of quality-related tasks. * **Robust Data Integrity:** TrackWise ensures data integrity and compliance with regulations such as 21 CFR Part 11 through features like electronic signatures, comprehensive audit trails that track all data entries, and stringent security measures to prevent unauthorized changes. * **Increased Transparency and Accountability:** The system maintains detailed audit trails and documentation, providing transparency and traceability for all quality-related activities, findings, and actions, thereby enhancing accountability across the organization. * **Ubiquitous Accessibility:** As a web-based application, TrackWise can be accessed from any device with an internet connection and appropriate permissions, facilitating remote work and real-time collaboration. * **Advanced Security Measures:** The software incorporates robust security features, including role-based access control, encryption, and authentication mechanisms, to safeguard sensitive quality data and ensure compliance with data privacy regulations. * **Significance of Electronic Signatures:** Electronic signatures within TrackWise are crucial for securely authorizing and authenticating data entries, maintaining the integrity and authenticity of electronic records in a regulated environment. * **Facilitates Inter-Departmental Collaboration:** TrackWise enables real-time data sharing across different departments within a pharmaceutical company, fostering improved communication and collaboration through a centralized platform. * **Customizable Workflows:** The software offers highly customizable workflows, forms, and reports, allowing organizations to adapt the system to their specific operational needs and regulatory requirements. * **Integration Capabilities:** TrackWise supports seamless integration with other critical enterprise systems such as Enterprise Resource Planning (ERP) systems (e.g., SAP), Laboratory Information Management Systems (LIMS), and Electronic Document Management Systems (EDMS), enabling efficient data exchange and workflow integration. * **Current Versions and Evolution:** The software is continuously updated, with versions like TrackWise 8.x, 9.x, and the latest TrackWise 10.x (released October 2023) offering enhanced functionalities and user experiences, with selection depending on organizational needs and infrastructure. Tools/Resources Mentioned: * **TrackWise:** Quality Management System software (versions 8.x, 9.x, 10.x) * **ERP (Enterprise Resource Planning) systems:** General mention, with SAP given as an example. * **LIMS (Laboratory Information Management Systems)** * **EDMS (Electronic Document Management Systems)** Key Concepts: * **QMS (Quality Management System):** A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. * **CAPA (Corrective and Preventive Actions):** Actions taken to eliminate the causes of existing nonconformities or other undesirable situations and to prevent their recurrence. * **Deviations:** Departures from approved instructions or established standards. * **Change Control:** A formal process used to ensure that changes to products, processes, or systems are introduced in a controlled and coordinated manner. * **Regulatory Compliance:** Adherence to laws, regulations, guidelines, and specifications relevant to the pharmaceutical industry (e.g., FDA, 21 CFR Part 11). * **FDA (Food and Drug Administration):** The U.S. federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. * **21 CFR Part 11:** Regulations issued by the FDA that set forth the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. * **Data Integrity:** The assurance that data is accurate, consistent, and complete throughout its lifecycle, crucial for regulatory compliance. * **Electronic Signatures:** A secure method for authorizing and authenticating data entries in electronic records, legally equivalent to handwritten signatures under 21 CFR Part 11. * **Audit Trails:** A chronological record of system activities, including who accessed what data, when, and what changes were made, essential for traceability and accountability. * **Role-Based Access Control (RBAC):** A security mechanism that restricts system access to authorized users based on their role within the organization. * **Encryption:** The process of converting information or data into a code to prevent unauthorized access. * **Authentication:** The process of verifying the identity of a user or system.

9.6K views

39.7

change control in pharmaceutical industrydata integrity in pharmaceutical industrypharmaceutical industry

42:26

Disrupting The Health Insurance Industry (with Jack Crotty)

Self-Funded

@SelfFunded

Feb 13, 2024

This video provides an in-depth exploration of how Adyptation, led by Director of Business Development Jack Crotty, is disrupting the health insurance industry through innovative specialty disease management and pharmaceutical sourcing. Crotty, drawing from his decade of experience in the insurance sector, including time on the carrier and broker sides, shares his journey into the startup world, driven by a desire to bring impactful, disruptive solutions to a system he believes is "craving disruption." The discussion centers on Adyptation's unique three-pronged approach: cost-effective pharmaceutical sourcing, comprehensive clinical support, and data-driven patient engagement via wearable technology, all aimed at optimizing health outcomes and significantly reducing costs for self-funded employers. Adyptation's core offering begins with pharmaceutical sourcing, primarily for specialty drugs from Canada, which delivers immediate, day-one savings for employers. Crotty highlights instances where this sourcing can lead to as much as a 30% reduction in total pharmacy spend. This substantial saving then strategically subsidizes the second pillar: a robust clinical platform. This platform provides personalized coaching and counseling from clinical pharmacists (Farm Ds) to members dealing with specialty diseases like Rheumatoid Arthritis. These pharmacists guide patients through their journey towards remission, focusing on medication adherence, lifestyle adjustments (e.g., diet, movement, sleep), and breaking down overwhelming health goals into manageable "baby steps." The third crucial component is the integration of wearable technology, such as Fitbits and Oura Rings, which are provided to members at no cost. These devices track key health metrics like movement and sleep, serving as an accountability tool for both the patient and their clinical coach. The data collected allows pharmacists to have objective insights into a member's daily habits, facilitating more targeted coaching and ensuring adherence to personalized health plans. The overall model is designed to align incentives, offering zero co-pays for members on sourced drugs and free wearables, thereby encouraging engagement and fostering better health outcomes, particularly for self-funded employers with 500 or more employees. Adyptation also emphasizes strategic partnerships with pass-through PBMs to ensure seamless integration and data flow, reducing administrative burdens for brokers and employers. Key Takeaways: * **Disruptive Business Model:** Adyptation's approach to healthcare disruption combines pharmaceutical sourcing, clinical support, and data-driven engagement, challenging traditional health insurance models by reallocating value to patients and employers. * **Significant Pharmaceutical Savings:** Sourcing specialty drugs, primarily from Canada, can yield substantial day-one savings for employers, with some experiencing up to a 30% reduction in total pharmacy spend. * **Strategic Funding of Clinical Care:** The savings generated from pharmaceutical sourcing are strategically used to subsidize a comprehensive clinical platform, ensuring that cost reduction directly translates into enhanced patient support. * **Specialized Clinical Coaching:** Clinical pharmacists (Farm Ds) provide personalized coaching for specialty disease patients, focusing on medication adherence, managing side effects, and guiding lifestyle modifications (e.g., diet, movement, sleep) to achieve remission. * **Data-Driven Patient Accountability:** Wearable devices (Fitbit, Oura Ring) track objective health data (movement, sleep), which clinicians use to hold patients accountable for their health goals and provide more informed, personalized guidance. * **Incentivized Member Engagement:** Patients are motivated to participate through direct financial benefits, such as zero co-pays for sourced specialty drugs and free wearable devices, removing common barriers to adherence and engagement. * **Target Market for Impact:** The model is most impactful for self-funded employers with 500 or more employees, where the 1-2% of the population with specialty diseases generates enough volume for significant cost savings and clinical benefit. * **Importance of PBM Partnerships:** Collaborating with pass-through PBMs that offer no-spread pricing and align with a forward-thinking approach is crucial for seamless data integration, efficient claims processing, and overall program success. * **"Robin Hood Effect" Philosophy:** The company aims to shift power and financial benefits away from large corporations and back to the individuals and employers the healthcare system is meant to serve. * **Incremental Progress for Health Outcomes:** Patient coaching emphasizes taking small, manageable "baby steps" towards health goals, recognizing the challenges faced by individuals with chronic conditions and promoting sustainable behavioral change. * **Broker Education and Simplification:** Success in the broker channel requires clear education on the solution's value proposition and simplifying the integration process to overcome the "noise" of numerous point solutions. * **Favorable Market Timing:** Current industry trends, including increased focus on transparency (e.g., CAA), fiduciary obligations, and rising healthcare costs, create a receptive environment for disruptive and cost-saving solutions like Adyptation's. Tools/Resources Mentioned: * **Fitbit:** A wearable device used for tracking activity and sleep. * **Oura Ring:** A smart ring used for tracking activity and sleep. * **Apple Watch:** Mentioned as a wearable device they previously used but pivoted away from. Key Concepts: * **Specialty Disease Management:** A focused approach to care for complex, chronic, or rare conditions that often require high-cost, specialized medications and ongoing support. * **Pharmaceutical Sourcing:** The practice of obtaining medications from alternative, often international, suppliers to achieve cost savings, particularly for high-cost specialty drugs. * **Pass-Through PBMs:** Pharmacy Benefit Managers that operate with full transparency, passing all negotiated discounts, rebates, and administrative fees directly to the client rather than retaining a "spread" on drug costs. * **Self-Funded Employers:** Companies that assume the financial risk for providing healthcare benefits to their employees, paying claims directly rather than through an insurance carrier. This allows for greater flexibility in plan design and the implementation of innovative solutions. * **Clinical Pharmacists (Farm Ds):** Pharmacists with advanced clinical training who provide direct patient care, including medication management, disease state management, and patient counseling, often as part of a healthcare team. * **Wearable Technology in Healthcare:** The use of smart devices worn on the body to collect health-related data (e.g., activity levels, sleep patterns, heart rate) for monitoring, personalized feedback, and behavioral modification in health management.

474 views

29.3

Innovative SolutionsInsurance ConsultingDisruption

1:00:21

How To Build Your Social Media Brand (with Jake Rushton)

Self-Funded

@SelfFunded

Feb 6, 2024

This video provides an in-depth exploration of how to build a social media brand and leverage content creation for business growth, trust, and lead generation. Host Spencer Smith, of the "Self-Funded" podcast, interviews Jake Rushton, a 401k and retirement planner who also runs Zeke Digital, a social media strategy consulting firm. The discussion centers on the transformative potential of content creation, emphasizing its long-term return on investment (ROI) and its ability to open unforeseen opportunities. Both speakers share personal anecdotes, highlighting how their careers have been significantly shaped by their commitment to consistently producing valuable content. The conversation delves into the common barriers to content creation, particularly fear and insecurity, and offers practical advice on overcoming them. Jake Rushton introduces his "PREP" method—Plan, Record, Edit, Post—as a structured approach to streamline the content creation process. He stresses the importance of authenticity over high-end production, advocating for the use of readily available tools like smartphones and free editing software. A significant portion of the discussion is dedicated to the strategic use of LinkedIn for B2B sales, positioning it as a crucial "personal website" for professionals and a powerful tool for search engine optimization (SEO). The video also explores the evolving landscape of social media algorithms, noting the shift from network-based to interest-based feeds, as exemplified by platforms like TikTok, Instagram Reels, and YouTube Shorts. This shift underscores the need for tailored content that resonates with specific audience interests. Ultimately, the speakers advocate for content creation as a "one-to-many" communication strategy that builds trust, establishes authority, and serves as a perpetual asset, continuously generating leads and opportunities for businesses and individuals alike, even while they are engaged in other activities. Key Takeaways: * **Content as a Perpetual Asset:** Video content, once created and published, acts as a living asset that continues to generate value, build trust, and open opportunities long after its initial release. It serves as an ongoing marketing and educational tool. * **Long-Term ROI, Not Immediate Sales:** Social media content creation is a marathon, not a sprint. The primary goal is not to make an immediate sale but to build relationships and establish authority over time, with ROI often manifesting years later. * **Overcoming Fear and Insecurity:** The biggest hurdle to content creation is often the fear of imperfection or judgment. The advice is to "just get started" and accept that early content will be imperfect, as consistency and authenticity outweigh polished production. * **Authenticity Trumps High Production Value:** Viewers prioritize genuine connection and valuable information over expensive, commercial-grade video production. Simple, authentic content created with a smartphone can be more effective than a costly, scripted commercial. * **The "One-to-Many" Communication Advantage:** Content creation allows professionals to scale their expertise and value beyond one-on-one interactions, reaching a broader audience more efficiently, similar to a webinar or public speaking engagement. * **LinkedIn as a Critical B2B Platform:** For B2B sales, LinkedIn functions as a personal website and a powerful SEO tool. Optimizing one's LinkedIn profile with a clear headline that communicates who you help and what problems you solve is essential for discoverability and engagement. * **The PREP Method for Content Creation:** Jake Rushton's framework includes: * **Plan:** Continuously capture content ideas from daily interactions, client meetings, and personal insights. * **Record:** Utilize simple equipment like a smartphone, a tripod, and good natural lighting. * **Edit:** Learn basic editing skills (e.g., using CapCut) to find your unique voice, improve storytelling, and become more efficient in recording. * **Post:** Consistently publish content, understanding the context of each platform and tailoring captions, but without overthinking or self-judging. * **Batch Content Creation for Consistency:** To maintain a consistent posting schedule without daily effort, record multiple pieces of content in one dedicated session (e.g., 3 hours of recording can yield a month's worth of content). * **Shift to Interest-Based Algorithms:** Social media platforms are increasingly prioritizing content based on user interests rather than just their network connections. Content creators should aim to produce material that aligns with specific audience interests to increase visibility. * **Building Trust and Authority Through Education:** Providing free, valuable content positions the creator as an expert and leader in their field, building trust that can lead to significant business opportunities, even if the content wasn't initially intended for that specific audience. * **Content Enhances Referrals:** Having readily available content allows referrals to easily find and consume information about a professional, validating their expertise and making the referral process more effective. * **Integrating Content into the Customer Journey:** Content should guide potential clients through a journey, from initial problem-solving clips to deeper educational resources, ultimately leading them to a clear call to action or engagement opportunity. * **Content for Business Efficiency and Pre-qualification:** Utilize content (e.g., a short video or PDF guide) to pre-qualify leads before meetings, ensuring that prospects are committed and informed, thereby making interactions more efficient. **Tools/Resources Mentioned:** * **CapCut:** A free mobile video editing application. * **iMovie:** A free video editing application for Apple devices. * **YouTube:** A video hosting and search engine platform. * **LinkedIn:** A professional networking platform, emphasized for B2B sales and personal branding. * **TikTok, Instagram Reels, YouTube Shorts:** Short-form video platforms driven by interest-based algorithms. * **Gary Vee, Alex Hormozi, Ryan Pineda, TK Kader:** Influential content creators and entrepreneurs cited as examples or inspirations. **Key Concepts:** * **Content as an Asset:** The idea that created content, particularly video, has enduring value and continues to work for you over time, generating leads and building your brand. * **Long-Term ROI:** The understanding that the benefits of content marketing are cumulative and may not be immediately apparent, requiring patience and consistent effort. * **One-to-Many Communication:** A strategy to leverage digital platforms to deliver a message or value proposition to a large audience simultaneously, scaling personal influence. * **Interest-Based Algorithms:** The evolution of social media algorithms to prioritize showing users content based on their demonstrated interests, rather than solely on their direct network connections. * **PREP Method:** A systematic approach to content creation (Plan, Record, Edit, Post) designed to make the process more manageable and effective. * **Batch Content Creation:** The practice of producing a large volume of content in a single, concentrated session to ensure a consistent publishing schedule over an extended period. **Examples/Case Studies:** * **Jake Rushton's 401k Journey:** Jake started with simple "Thursday Thoughts" videos on LinkedIn, which evolved into the "401 Jake" brand (including branded hats for marketing) and eventually led to Zeke Digital, his social media consulting firm. * **Winning a $20 Million 401k Plan:** Jake recounts how a group of doctors, who had Googled his name, found his YouTube videos (originally created to teach other advisors about 401ks and content creation). These videos built enough trust and authority for the doctors to hire him on the spot for their $20 million plan. * **Spencer Smith's Self-Funding Content:** Spencer began his content journey with basic videos like "Stop Loss 101" on YouTube, which helped him educate brokers on self-funding, ultimately growing his personal brand and business opportunities. * **Jake's Wife and TikTok:** Jake's wife, an elementary teacher, returned to TikTok solely to follow Taylor Swift's concert. The algorithm quickly adapted, showing her content related to Taylor Swift and teachers using her songs in their classrooms, illustrating the power of interest-based feeds. * **TK Kader's "Unstoppable" YouTube Channel:** Spencer mentions TK Kader, a serial entrepreneur, who generates all his leads for his SAS consulting business through his YouTube channel by consistently publishing deep-dive content.

284 views

31.3

Content CreationTrust BuildingMarathon Running

9:52

Veeva Vault RIM Submission Publishing Overview : How Vault Submission Publishing Works

Anitech Talk

/@AnitechTalk

Feb 5, 2024

This video provides an in-depth overview of Veeva Vault RIM Submission Publishing, detailing its features and workflow for managing electronic submissions to health authorities. The speaker introduces the module as a comprehensive solution designed to streamline the content planning, publishing, and finalization processes required for regulatory submissions. The primary goal is to ensure compliance with evolving regulations by leveraging pre-configured actions and specialized capabilities within the Veeva Vault platform. The discussion emphasizes how the system handles content, which includes documents and required details, from preparation through to submission, enabling users to manage changes for both new and existing marketed products. The presentation then delves into specific features that enhance the efficiency and accuracy of the submission process. Key functionalities highlighted include "link publishing," which automatically converts internal document references into functional PDF links upon publication, and "continuous publishing," allowing documents to be published automatically as they become part of a content plan or as related content is updated. A crucial aspect is "continuous validation," where the system automatically checks if submissions meet health authority criteria (e.g., eCTD format), providing immediate feedback on errors or warnings. The video also covers "publishing status indicators," visual cues that inform users about the progress and state of their submissions, and "document and object lifecycle user actions," which enable users to manage the states of content plans and items from draft to final approval. Finally, the speaker outlines the step-by-step process for working with submission publishing. This typically involves preparing content, creating a submission record, developing a content plan (a collection of documents), initiating the publishing process, and then proceeding through document release, internal review, validation, and correction stages. This structured workflow is essential for situations like introducing new products or making significant changes to existing ones, where a collection of relevant documents needs to be submitted for approval. The video concludes by mentioning the "gateway feature" for direct submission to health authorities and the "submission archive viewer" for accessing published documents, underscoring the end-to-end capabilities of Veeva Vault RIM in regulatory affairs. Key Takeaways: * Veeva Vault RIM Submission Publishing offers a complete process for handling content planning, publishing, and finalization of electronic submissions to health authorities, ensuring regulatory compliance. * The system allows users to create "content plans," which are collections of documents and associated details necessary for submission, particularly for new product introductions or updates to existing products. * "Link publishing" is a key feature that automatically transforms internal references within Veeva Vault documents into functional PDF hyperlinks when content is published, enhancing navigability and accuracy. * "Continuous publishing" enables documents to be published automatically as they are added to a content plan or as related content undergoes changes, reducing manual effort and accelerating the submission timeline. * "Continuous validation" is crucial for compliance, as it automatically checks submissions against health authority validation criteria (e.g., eCTD format) and provides real-time feedback on errors or warnings. * "Publishing status indicators" (e.g., green, half-orange, orange circles) provide visual cues on the submission record, indicating whether content is published, in progress, or has pending validation or errors. * "Document and object lifecycle user actions" empower users to manage the states of content plans and content plan items, allowing transitions from draft to baseline, logged, or complete states, and enabling actions like inactivating items. * The overall workflow for submission publishing involves creating a submission record, preparing content, building a content plan, initiating publishing, and then proceeding through document release, internal review, validation, and correction before final submission. * The "gateway feature" facilitates direct submission of finalized content to health authorities, where permitted, and allows for the reception of acknowledgements and attachments, streamlining communication. * The "submission archive viewer" provides a centralized location for users to view and access published documents, ensuring transparency and easy retrieval of submitted materials. * The system is designed to reduce the need for manual checks by automating publishing and validation processes, thereby increasing efficiency and reducing the risk of human error in regulatory submissions. Tools/Resources Mentioned: * Veeva Vault RIM * Veeva Vault Submissions Publishing module * Submission Archive Viewer Key Concepts: * **Content Plan:** A collection of documents and associated details required for a regulatory submission. * **Link Publishing:** A feature that converts internal document references into functional PDF hyperlinks during the publishing process. * **Continuous Publishing:** Automated publishing of documents as they become part of a content plan or as related content is updated. * **Continuous Validation:** Automated checking of submission content against health authority validation criteria (e.g., eCTD) to ensure compliance. * **Publishing Status Indicator:** Visual cues (e.g., colored circles) that denote the current status of a submission's publishing and validation process. * **Document and Object Life Cycle User Action:** User-initiated actions to change the state of documents, content plans, and content plan items within Veeva Vault. * **eCTD (Electronic Common Technical Document):** A standard format for submitting applications, amendments, supplements, and reports to regulatory authorities. The video mentions checking against "dosier format" like eCTD. * **Health Authority:** Regulatory bodies (e.g., FDA, EMA) to whom pharmaceutical and life sciences companies submit regulatory documents. Examples/Case Studies: * Submitting documents for the introduction of a **new product**. * Submitting documents for **changes or updates to an existing marketed product**.

1.9K views

40.8

#Veeva#Submission#Publishing

1:45

Tip of the Week #2 - Navigating the Veeva Split From Salesforce

CapStorm

/@CapstormSoftware

Feb 5, 2024

This video provides an urgent, strategic overview of the impending separation of Veeva Systems from the Salesforce platform, a major event scheduled to begin with the first customer onboarding to Veeva Vault in May 2024. The speaker, Michael Kramer from CapStorm, addresses this critical industry shift directly to healthcare and life sciences customers, emphasizing that this transition necessitates immediate and decisive action regarding their enterprise technology stack and data management strategy. The core message is a call for preparedness, urging organizations to start planning now for the inevitable changes this split will bring to their commercial and operational systems. The central theme revolves around the three strategic options facing regulated life sciences companies: a full migration to the proprietary Veeva Vault platform, a decision to remain fully on the existing Salesforce infrastructure, or the adoption of a hybrid model combining elements of both. The speaker stresses that regardless of the chosen path—whether transitioning, staying put, or integrating—the most critical component of the strategy must be centered on data. This is particularly salient because the data housed within these systems, especially in the pharmaceutical and biotech sectors, is overwhelmingly composed of highly sensitive and regulated information, specifically Protected Health Information (PHI) and Personally Identifiable Information (PII). The primary actionable advice presented is the necessity of securing autonomous control over all existing Salesforce data. This means establishing a plan to obtain and maintain a real-time, independent copy of all crucial PHI and PII data. This necessity stems from two major requirements. First, having an autonomous copy ensures data availability and integrity for regulatory compliance, audit trails, and GxP requirements, irrespective of the platform migration status. Second, it facilitates downstream data usage, allowing organizations to leverage their historical and operational data for business intelligence, analytics, and custom applications without being tethered solely to the operational CRM/Vault instance. In essence, the video serves as a warning and a practical guidepost for regulated industries navigating a significant vendor ecosystem change. It frames the Veeva/Salesforce split not merely as a technical migration challenge, but as a critical data governance and risk management exercise. The emphasis on securing real-time data copies underscores the importance of maintaining robust data pipelines and business continuity, ensuring that commercial operations and regulatory reporting remain uninterrupted during and after the transition period. Key Takeaways: * **Urgent Strategic Decision Point:** Life sciences and healthcare organizations must finalize their strategy regarding the Veeva split from Salesforce, with the initial customer onboarding to Veeva Vault commencing in May 2024, signaling immediate urgency for planning. * **Three Primary Paths:** Companies must choose between three distinct strategic approaches: a full migration to Veeva Vault, retaining the existing commercial operations on the Salesforce platform, or implementing a hybrid model utilizing both systems. * **Mandate for Immediate Planning:** The most crucial tip is to initiate comprehensive planning immediately, covering not only the platform decision but, more importantly, the associated data strategy for the transition. * **Focus on Highly Regulated Data:** The majority of data residing in these CRM instances is highly sensitive, including PHI (Protected Health Information) and PII (Personally Identifiable Information), demanding stringent data handling protocols during any system change. * **Requirement for Autonomous Data Control:** Organizations must establish a plan to gain and maintain autonomous control over their Salesforce data, ensuring that critical information is not solely dependent on the operational CRM environment. * **Real-Time Data Copy Necessity:** Securing a real-time copy of all crucial data is essential for business continuity, regulatory compliance, and mitigating risks associated with platform transitions or vendor lock-in. * **Data Usage Downstream:** Having an independent, real-time copy of the data facilitates its usage for downstream applications, such as advanced analytics, business intelligence dashboards, custom AI model training, and integration with other enterprise systems. * **Backup and Recovery Requirements:** The data strategy must explicitly address robust backup and recovery requirements, ensuring data integrity and availability for audit purposes and operational resilience, especially for GxP-relevant data. * **Risk Mitigation through Preparation:** Proactive data planning minimizes the risks associated with platform migration, data loss, and compliance breaches, which are particularly severe when dealing with PHI and PII. * **Data Engineering as a Foundational Step:** Regardless of the chosen platform (Vault, Salesforce, or hybrid), robust data engineering services are required to build and maintain the necessary data pipelines for real-time synchronization and autonomous data storage. Tools/Resources Mentioned: * Veeva Vault * Salesforce Key Concepts: * **Veeva Split from Salesforce:** The ongoing industry event where Veeva Systems is separating its core commercial operations and data management platforms from the underlying Salesforce technology stack, requiring customers to choose their future platform. * **PHI (Protected Health Information) & PII (Personally Identifiable Information):** Highly sensitive data types regulated by laws like HIPAA (in the US) and GDPR (in the EU), which constitute the majority of data held by life sciences companies in their CRM systems. * **Veeva Vault:** Veeva’s proprietary cloud platform designed specifically for the life sciences industry, offering solutions for clinical, regulatory, quality, and commercial content and data management. * **Autonomous Data Control:** The ability for a company to independently access, manage, and utilize its operational data without reliance on the primary SaaS vendor's platform, typically achieved through data replication or real-time backup solutions.

164 views

20.2

4:44

Health Insurance Company Buys Doctor Practice... A Fable

AHealthcareZ - Healthcare Finance Explained

@ahealthcarez

Feb 4, 2024

This video provides an insightful exploration into the financial intricacies and potential pitfalls of vertical integration within the healthcare industry, specifically focusing on health insurance carriers acquiring physician practices. Dr. Eric Bricker presents a "fable" about a large multi-specialty physician practice that sells to a vertically integrated insurance carrier. The narrative serves to illustrate how such acquisitions, while seemingly beneficial, can lead to increased healthcare costs and manipulative financial practices, particularly concerning earnout agreements. The fable begins with a successful multi-specialty practice utilizing an external vendor, "Vendor A," for a specific patient service, costing $300 per patient per day. This arrangement was mutually beneficial for the practice, the vendor, and the patients. However, upon acquisition by the insurance carrier, a significant change occurs: the carrier replaces Vendor A with its own subsidiary, "Vendor I," which performs the same service but charges $800 per patient per day. The speaker highlights the counterintuitive nature of replacing a cheaper vendor with a more expensive one, revealing the carrier's strategy to increase its overall revenue by inflating healthcare costs billed to other insurance carriers and employers. The narrative further complicates with the introduction of an "earnout" clause in the acquisition agreement. This clause stipulated that the physician practice would receive future payments from the insurance carrier based on its post-acquisition profitability. By replacing the $300 Vendor A with the $800 Vendor I, the insurance carrier intentionally diminished the acquired practice's profit margins. This strategic move directly reduced the future earnings of the physician practice, thereby decreasing the earnout payments the insurance carrier was obligated to make. The speaker concludes by emphasizing that the insurance company "won double" – increasing its revenue through higher service charges and simultaneously reducing its acquisition payout. Key Takeaways: * **Vertical Integration's Hidden Costs:** The video challenges the common perception that vertical integration in healthcare necessarily leads to cost reduction. Instead, it demonstrates how an insurance carrier owning both the payer and provider/vendor can strategically increase overall healthcare costs to boost its own revenue. * **Revenue Generation Through Cost Inflation:** Vertically integrated insurance carriers can profit by replacing cost-effective external vendors with their own, more expensive subsidiaries. This practice shifts costs to other payers (e.g., other insurance companies, employers), increasing the acquiring carrier's top-line revenue. * **Earnout Manipulation in M&A:** The "fable" serves as a stark warning about the potential for earnout clauses in mergers and acquisitions to be manipulated. Acquirers, especially those with vertically integrated models, can intentionally reduce the profitability of acquired entities to minimize future earnout payments. * **Importance of Due Diligence in Acquisitions:** For any entity considering selling to a larger, vertically integrated organization, thorough due diligence must extend beyond initial valuations to scrutinize potential conflicts of interest, vendor relationships, and the acquiring entity's incentives post-acquisition. * **Impact on Acquired Entities' Profitability:** The strategic replacement of vendors can significantly worsen the financial performance and profit margins of an acquired practice, directly impacting its ability to meet earnout targets and potentially undermining its long-term financial health. * **Beware of Financial Incentives:** Healthcare stakeholders, including physician practices, employers, and other payers, need to be acutely aware of the complex financial incentives at play in vertically integrated healthcare systems, as these can lead to outcomes that are not in the best interest of patients or overall cost efficiency. * **Strategic Cost-Cutting for Acquirers:** The example illustrates a "genius" (from the acquirer's perspective) method of reducing acquisition costs by diminishing the acquired entity's performance, thereby saving money on future earnout payments. * **Transparency in Vendor Selection:** The scenario underscores the lack of transparency in vendor selection and pricing within vertically integrated systems, where internal vendors may be prioritized for financial gain rather than cost-effectiveness or quality. * **Broader Implications for Healthcare Finance:** The video highlights a critical aspect of healthcare finance where market power and ownership structures can be leveraged to increase profits at the expense of higher overall healthcare spending. Key Concepts: * **Vertical Integration:** The ownership of multiple stages of a supply chain by a single company. In healthcare, this refers to an entity (like an insurance carrier) owning providers (like physician practices) or other service vendors. * **Earnout:** A contractual provision in an acquisition agreement where a portion of the purchase price is contingent on the acquired company achieving certain financial milestones or performance targets after the acquisition. * **Multi-specialty practice:** A medical practice that employs physicians from various medical specialties, often operating across multiple locations. * **Insurance Carrier:** An organization that provides health insurance coverage, typically by collecting premiums and paying for healthcare services.

3.0K views

33.4

36:48

Season 2 Episode 7: Sites Are Voicing Their Concerns, But Are We Listening?

Veeva Systems Inc

@VeevaSystems

Jan 31, 2024

This podcast episode, hosted by Veeva Systems Inc, provides a critical examination of the challenges faced by clinical trial sites, emphasizing the detrimental effects of inconsistent technology and poor industry communication on site operations and patient care. Featuring Vivienne van de Walle, a medical director and research site founder, and Bree Burks, Veeva's VP of Strategy for Site Solutions, the discussion centers on the urgent need for sponsors, CROs, and vendors to genuinely listen to sites, simplify processes, and integrate technology more effectively to support, rather than hinder, clinical research. The conversation is framed around the idea that research happens *at the site*, making site feedback paramount for industry improvement. A major theme explored is the overwhelming technological burden placed on sites, which Dr. van de Walle vividly describes as an "escape room" due to the multitude of vendors, codes, URLs, and activation processes required for a single trial. This complexity takes time away from patient care, which sites view as their primary pain point. Beyond technology, universal challenges include staffing shortages—often because young professionals are unaware of clinical research as a viable career path—and persistent issues with budgeting, finances, and timely payments. The speakers stress that technology should be a supportive tool, not the focus of the trial itself, and criticize the current practice of providing training without allowing sites hands-on experience until the first patient is present. The discussion pivots to the critical need for consistency and interoperability. Sites often deal with different activation methods (e.g., e-diaries, iPads, portals) even within trials run by the same service provider, highlighting a lack of internal coordination among project teams. A key procedural flaw identified is the lack of transparent issue tracking; site deviations are often logged for problems caused by vendors, couriers, or malfunctioning technology, leading to unfair negative evaluations of the site's performance. Dr. van de Walle shared a crucial insight: vendors often assume they are delivering good service if sites resolve issues internally without calling the help desk, reinforcing the need for a transparent, industry-wide issue log that tracks problems back to the responsible party (vendor, courier, or sponsor). Looking toward the future, the speakers advocate for significant procedural and technological shifts. Bree Burks emphasizes embedding clinical trials into routine healthcare to increase patient access and reduce the variation in how trials are conducted. Dr. van de Walle introduced a successful operational model at her site where staff are assigned specialized roles (e.g., e-diaries, data entry) based on their aptitude, rather than forcing one coordinator to handle all technologies from A to Z. The ultimate hope is to move away from a "tick box" compliance culture toward sensible, quality-focused evaluations and to achieve true system communication, allowing seamless data flow across different applications and stakeholders, similar to consumer technology standards. Key Takeaways: * **Technology Overload is a Major Pain Point:** Clinical trial sites face an overwhelming "escape room" scenario due to managing a multitude of disconnected vendor systems, requiring excessive time spent on logins, codes, and activations that detracts from patient care. * **Lack of Standardization and Consistency:** Even within the same vendor or sponsor, trials often use different methods for activating patient technology (e.g., e-diaries via iPad vs. portal), creating unnecessary complexity and friction for site staff. * **Need for System Interoperability:** The industry must move beyond siloed systems and enable technology platforms to communicate seamlessly, allowing for a "one entry, read many times" data flow, which is crucial for efficient data engineering and site operations. * **The Deviation Log Problem:** Current regulatory processes unfairly penalize sites by logging deviations for issues caused by external factors like vendor software bugs, late drug delivery, or courier errors, masking the true source of operational failures. * **Mandate Transparent Issue Tracking:** The industry needs a transparent, shared issue log (or deviation log) that tracks problems back to the responsible party (sponsor, CRO, vendor, or courier) to ensure accountability and drive necessary software or process improvements. * **Technology Training Must Be Hands-On:** Sites often receive training but lack practical, hands-on experience with new systems until the first patient visit, turning the initial patient into a "trial in the trial" and weakening the patient-caregiver relationship. * **Shift Staffing Models:** Sites can optimize efficiency and staff satisfaction by moving away from the traditional model of one coordinator handling all aspects (A-to-Z) of a trial, instead assigning specialized roles based on staff aptitude (e.g., one person excels at e-diaries, another at data entry). * **Address Patient Access and Centricity:** Current technology fails patients by making it nearly impossible to easily find and screen for clinical trials; true patient centricity requires designing technology that prioritizes simple access and communication. * **Avoid Assumptions about Technology Literacy:** Sponsors and vendors must avoid assuming technology access (e.g., internet, computers) or literacy based on patient demographics (e.g., age), as this creates diversity barriers and complicates trial participation. * **Eliminate the "Tick Box" Culture:** The industry must move away from simply ticking boxes for training completion and compliance, focusing instead on the quality and sensible application of training and procedures to ensure actual preparedness and quality outcomes. * **Clinical Trials Must Be Embedded in Routine Care:** To increase patient access and physician participation, clinical research needs to be simplified and integrated into the standard healthcare system, rather than remaining a specialized, separate activity. * **Acknowledge Site as the Hub:** Sponsors and CROs must recognize that the site is the central "Lynch pin" and the hub of all information exchange (sponsor to site, site to patient, data return), requiring robust support and communication infrastructure. Tools/Resources Mentioned: * **Veeva ID:** A Veeva product announced at the summit, designed to improve the site experience for logging into various systems. * **Veeva Study Portal:** A Veeva product announced at the summit, aimed at streamlining site operations. * **EDC (Electronic Data Capture):** Mentioned as a historical technological shift 20 years ago that failed to account for increased site workload. * **eDiaries:** Electronic patient diaries used in trials. * **IVRS (Interactive Voice Response System):** Mentioned as a historical technology used for randomization. Key Concepts: * **Patient Centricity:** The concept of designing trials and technology around the needs and experiences of the patient, which the speakers argue is currently lacking in technology implementation. * **Site Solutions:** A strategy area within Veeva focused on improving the tools and processes used by clinical trial sites. * **GxP / 21 CFR Part 11 (Implied):** The regulatory environment is referenced through the discussion of protocol rigidity, deviations, and the need for audit trails and transparency in issue logging.

438 views

27.8

Richard YoungVivienne van de Wallemedical director and founder of PT&R

31:52

Season 2 Episode 6: Transforming Clinical Operations: What Comes Next?

Veeva Systems Inc

@VeevaSystems

Jan 31, 2024

This podcast episode, hosted by Veeva Systems, features an in-depth conversation with Emma Earl, Bayer’s Head of Clinical Trial Management Services and Solutions, focusing on the dramatic transformation of clinical operations over the last two decades and the challenges and opportunities that lie ahead. The discussion centers on the shift from legacy paper-based systems to modern digital platforms, emphasizing the critical balance between people, process, and technology required to deliver efficient and patient-centric clinical trials. Emma Earl, drawing on over 20 years of industry experience, provides a perspective rooted in operational history, having transitioned from a Clinical Research Associate (CRA) role into defining and implementing clinical trial technologies, including a significant focus on Veeva Vault clinical implementations. A major theme explored is the industry's evolution from completely paper-based processes—including paper CRFs, manual data entry, and physical document handling—to the current digital landscape utilizing Electronic Data Capture (EDC) and modern Clinical Trial Management Systems (CTMS). This transition, while initially met with skepticism, has provided crucial visibility and transparency, enabling organizations like Bayer to look across studies, identify trends, and assess overall performance metrics. Earl highlights that the complexity of modern protocols, including those for advanced research like gene and cell therapies, necessitates flexible systems and processes that can accommodate "edge cases" without creating 25 different workflows, driving the need for a simplified, consolidated technology landscape. The speakers dedicate significant time to the perennial challenge of balancing people, process, and technology. While technology enables efficiency and reduces errors, the human element remains paramount, especially since clinical research fundamentally occurs when people (site staff, patients) interact. Earl argues that technology should serve to enable people, making processes better and easier. She stresses that the ultimate goal is not just adding new functionality but fixing existing problems, exemplified by the energy derived from successful process simplification, such as reducing the number of system roles. Furthermore, the conversation addresses the evolving definition of "monitoring," which has broadened beyond the traditional CRA role to include collaborative data review between clinical operations and data management, necessitating clear role definitions to avoid inefficiency and duplication of work. ### Detailed Key Takeaways * **Consolidating the System Landscape is a Key Priority:** Bayer's current focus is streamlining its technology environment by minimizing the need for complex integrations and leveraging platform features (like Veeva Vault) where possible. The goal is to achieve a simpler, more efficient landscape, with the ultimate win being the ability to retire legacy systems (e.g., a final Legacy CTMS). * **Process Re-evaluation Must Accompany Technology Implementation:** Implementation projects should be used as opportunities to critically revisit and question existing processes, rather than simply "lifting and shifting" old workflows onto new technology. This ensures that new systems are utilized to their full potential for optimization. * **Inefficiency is the Primary Target for Elimination:** The greatest wish for transformation is the elimination of inefficiency—getting rid of unnecessary steps and processes that exist only because of historical incidents or inertia. Organizations must be willing to stop and rethink whether long-standing processes are still required. * **Scientific Complexity Drives Operational Challenges:** The increasing complexity of clinical protocols, especially in advanced therapies, demands systems and processes that can accommodate numerous "edge cases" without sacrificing standardization or creating overly fragmented workflows. * **People are the Most Important Element in the Triad:** While technology and process are critical, clinical trials cannot function without people. Technology's role is to enable staff to perform better, recognizing that success hinges on people's willingness and mindset to leverage new processes and systems. * **Site Centricity is a Catalyst for Overall Success:** Solving the problem of making sites happy is identified as the single most impactful change an organization can make. Site satisfaction has a huge knock-on effect on patient experience and the sponsor's ability to run trials quickly. * **Avoid Disproportionate Prioritization of Users:** The industry often vacillates between focusing heavily on sites or heavily on patients. True success requires a balancing act—solving the "Rubik's Cube" by addressing the needs of all six sides (all stakeholders) simultaneously. * **The Definition of Monitoring Has Evolved:** The term "monitoring" is now much broader than traditional CRA site visits. Clarity is needed between clinical operations and data management regarding their respective roles in data review and oversight to ensure efficient collaboration and prevent duplication of effort. * **Early, Broad Exposure is Formative for Leaders:** Starting in a small biotech or CRO, where individuals are exposed to a wide range of tasks (e.g., data management, monitoring, closeout visits), provides a critical foundation and broad experience that shapes future technology and process definition roles. * **Learning Comes from Problem Solving:** As an industry lesson, it is crucial to remember that "you never learn anything from something that goes well." Troubleshooting and problem-solving exercises, often triggered by new scientific or operational scenarios, generate energy and lead to innovation. ### Key Concepts * **Veeva Vault Clinical Implementations:** The use of Veeva's suite of clinical applications (e.g., CTMS, eTMF) to manage and execute clinical trials, a core technology focus for Bayer's clinical operations team. * **Incompetence Intolerance:** A personality trait described as a strength, where individuals are driven by a desire to fix inefficient or poorly designed processes, often leading them toward technology and process optimization roles. * **Site Centricity:** The strategy of designing clinical trial processes and technology solutions with the needs and pain points of the investigative sites (hospitals, clinics) as a primary focus, recognizing their crucial role in patient interaction and data collection. * **Legacy CTMS:** Older, often fragmented or non-integrated Clinical Trial Management Systems that modern organizations are actively trying to replace or consolidate into unified platforms. ### Examples/Case Studies * **The Shift from Paper-Based Monitoring:** The speaker recalls the early days of monitoring, involving paper CRFs, DCFs, green pens, Post-it notes, and physically bundling documents in cars—a stark contrast to current digital access via websites and EDC systems. * **EDC Adoption Skepticism:** The initial rollout of laptops for Electronic Data Capture (EDC) was met with widespread industry skepticism that "this is never going to work," highlighting the initial resistance to digital transformation. * **Collaboration-Driven Process Change:** Bayer recently had to re-evaluate how they number their studies due to a new collaboration, demonstrating how external factors force internal process adjustments and problem-solving exercises within the team.

198 views

27.2

Richard YoungBayerHead of Clinical Trial Management Services and Solutions

2:27

Feature Video | Handle picklists in Veeva Vault

dqMan

/@fme_dqMan

Jan 31, 2024

This video provides a focused product demonstration illustrating the efficient management of picklists within Veeva Vault using the dqMan Veeva Vault Edition 23.2 administration tool. The primary purpose of the demonstration is to show how this specialized tool can boost productivity for Veeva Vault experts by streamlining common configuration tasks that are typically required when initiating or customizing a new Vault instance. These tasks include defining types, fields, objects, and, specifically, picklists, which often need to be tailored to accommodate legacy data or specific organizational requirements. The demonstration highlights the comprehensive feature set of dqMan for handling picklists. Users gain the ability to view all existing picklists, clearly differentiating between standard and custom lists via distinct icons. By selecting an existing picklist, administrators can instantly view and edit associated values, change the display label, and navigate directly to the document types or subtypes where that picklist is currently in use. This centralized view and easy navigation are crucial for maintaining system integrity and understanding the impact of configuration changes across the regulated environment. A key focus of the video is the creation of a new custom picklist, exemplified by defining a list for "FME products." The tool automates several critical steps, ensuring compliance and speed. When defining the new picklist, the system automatically generates the technical name in accordance with strict Veeva naming conventions, a feature that minimizes administrative errors and ensures consistency. The video then showcases three methods for adding values to the newly created picklist: manual entry via the 'Add' button, importing from an external file, or the highly efficient method of pasting values directly from the clipboard (e.g., from a spreadsheet). When values are pasted, dqMan provides an immediate pop-up option to remove spaces and special characters, and automatically generates the internal name and status for each label provided. The entire process is concluded by a single click on the 'Save' button to publish the new picklist and its values to the live Veeva Vault environment. Key Takeaways: • **Streamlined Vault Configuration:** The use of specialized administration tools like dqMan significantly speeds up the initial configuration phase of a new Veeva Vault instance, particularly when customizing default settings for types, fields, objects, and picklists to align with client legacy data requirements. • **Centralized Picklist Management:** Administrators gain a dedicated section to view and manage all picklists, with clear visual indicators (icons) distinguishing between standard, system-defined picklists and custom lists created for specific client needs. • **Efficiency in Editing and Auditing:** The tool allows for quick viewing and editing of existing picklist values and labels, alongside the ability to immediately trace where a specific picklist is utilized (types or subtypes), which is essential for impact analysis before making changes in a regulated environment. • **Automated Naming Convention Compliance:** When creating new picklists, the administration tool automatically generates the required internal name based on the label provided, strictly adhering to Veeva naming conventions, thereby reducing manual effort and ensuring system consistency. • **Bulk Data Import Capability:** The most efficient method demonstrated for populating a new picklist is the copy-and-paste function from external sources like spreadsheets, allowing administrators to rapidly transfer large sets of values without manual entry. • **Data Cleansing on Import:** During the bulk import process (copy/paste), the tool offers an immediate option within the pop-up window to automatically remove unwanted spaces and special characters from the imported labels, ensuring clean data entry into the Vault system. • **Automated Value Generation:** When only the display label is provided during bulk import, the tool automatically generates the corresponding internal name and sets the default status for each picklist value, minimizing the required input fields for the administrator. • **Simplified Publishing Process:** After configuration and value import are complete, the changes are published to the Veeva Vault environment via a single "Save" button click, simplifying the deployment of configuration updates. • **Targeted Productivity Enhancement:** The tool is specifically designed to boost the productivity and efficiency of "Veeva Vault experts," addressing common pain points associated with high-volume, repetitive configuration tasks inherent in system administration. Tools/Resources Mentioned: * **Veeva Vault:** The core platform being administered, used widely in the life sciences industry for regulated content and data management. * **dqMan Veeva Vault Edition 23.2:** A professional, third-party administration tool developed by fme, designed to enhance productivity and efficiency for Veeva Vault experts. Key Concepts: * **Picklists:** Configurable lists of predefined values used across Veeva Vault objects and documents to ensure data consistency and standardization (e.g., status, product names, categories). * **Veeva Naming Conventions:** The strict technical rules governing the internal names of fields, objects, and picklists within the Veeva platform, which must be followed for proper system function and integration.

206 views

25.4

fmeadministrationveeva