Leveraging Your Veeva Vault Investment

This video provides an in-depth exploration of maximizing investment in Veeva Vault, a critical platform for life sciences companies. Presented by Daelight Solutions, an IT consulting company specializing in life sciences, the webinar focuses on the technical and business considerations required when adding new functional capabilities, applications, or integrating systems within an existing Veeva Vault environment. The speakers, Dan Wheeler (Founder and CEO) and Terry Montez (Clinical Practice Lead), share their expertise and real-world insights, emphasizing that the "go-live" of a Veeva Vault implementation is merely the beginning of an ongoing journey that requires strategic planning and disciplined management.

The presentation begins by outlining the typical customer journey with Veeva Vault, from initial planning and design through configuration, build, testing, and eventual go-live. It then transitions to highlight the continuous nature of managing a Veeva Vault investment, which includes navigating three annual releases, user-specific enhancements, shifts in business direction (e.g., acquisitions, insourcing TMF), future integrations, and the expansion into additional Veeva Vault suites or applications. To manage this inherent complexity, the speakers introduce a robust framework centered on roadmaps, change management, and solution governance, stressing that proactive planning is paramount to avoid chaos and ensure long-term success.

The core of the webinar delves into practical examples and case studies from Daelight Solutions' client engagements. These examples illustrate common challenges and best practices when expanding Veeva Vault usage, such as adding Study Startup (SSU) or Clinical Trial Management System (CTMS) to an existing eTMF Vault, integrating Registrations into a Submissions Vault, deploying new Vault suites (Clinical, Quality, Regulatory) simultaneously, and leveraging advanced features like SiteConnect. Each case study provides specific details on issues encountered—like data model inconsistencies, legacy data migration complexities, global directory duplications, and the need for cross-functional alignment—along with actionable recommendations for overcoming them, underscoring the critical role of data governance and early stakeholder collaboration.

Key Takeaways:

• Go-Live is Just the Beginning: A Veeva Vault implementation's go-live marks the start of a continuous journey involving annual releases, user enhancements, business shifts (e.g., acquisitions, insourcing TMF), and potential future integrations or expansions into additional Vault suites and applications.
• Robust Roadmaps are Essential: Develop a comprehensive roadmap aligned with company strategies and objectives, securing buy-in from executive sponsors and cross-functional leads. This roadmap must include realistic timelines, budgets, and a strong focus on change management, training, and communication to ensure widespread adoption.
• Disciplined Change Management: Implement a formal release management plan that clearly defines roles and responsibilities for IT, business, validation, and quality partners. Utilize a Change Advisory Board (CAB) to prioritize changes, assess the impact of Veeva releases, and strategically defer requests if out-of-the-box functionality is imminent, aiming to keep solutions as standard as possible.
• Strong Solution and Data Governance: Establish robust solution governance to ensure compliance with industry regulations (FDA, EMA, GxP, 21 CFR Part 11) and best practices. Crucially, implement data governance (people, process, technology) to define naming conventions, manage master data (e.g., organizations, personnel), and maintain consistency across all Vaults, especially for shared data.
• Early Planning Prevents Rework: When adding new applications (e.g., SSU to eTMF), engage all stakeholders and conduct thorough analysis before configuration. This includes re-evaluating TMF index, milestone sets, and EDLs to build a foundational structure that accommodates future functionality and avoids costly rework.
• Thorough Data Model Analysis for Integrations: For applications with distinct data models (e.g., product-based Registrations versus submission-based Submissions), perform in-depth data model analysis upfront. Understand how new data structures will expand and impact existing models, and address legacy data integrity issues at the source prior to migration.
• Engage Experts for Complex Processes: When business processes or data usage are unclear, particularly for complex systems like Registrations, engage experts (e.g., from Veeva) to understand downstream data utilization. This insight helps inform configuration decisions and ensures the system meets long-term business needs.
• Test with Diverse Scenarios: Before full rollout, manually test new configurations by adding a few diverse product types or scenarios. This iterative testing helps work out kinks, validate data organization, and ensures the system functions as expected across various use cases.
• Cross-Suite Standard Alignment: When deploying multiple Vault suites (e.g., Clinical, Quality, Regulatory), dedicate significant effort to aligning on support processes, data sharing standards, SOP updates, and standard terminology across all domains from the outset. Early and continuous participation from all affected groups is critical.
• Centralize Vault Management: To minimize confusion and service impact, centralize the management of all Veeva Vaults, including terminology, naming conventions, object relationships, and communication standards. This provides a consistent framework for IT support and users, even if initial naming choices were suboptimal.
• Strategic SiteConnect Implementation: For SiteConnect, define clear business decisions regarding document flow (site to sponsor, sponsor to site), internal connectivity for regulatory/safety documents, and document packages to be shared. Adapt internal processes (e.g., site connection states) and SOPs to accommodate a hybrid environment of sites using and not using SiteVault.
• Anticipate Global Directory and User Provisioning Impacts: Integrating external systems like SiteConnect significantly impacts global directory structures (e.g., shifting from hospital names to department-specific organizations, incorporating USN numbers) and user provisioning processes, requiring data reformatting and new rules.
• Leverage Cloud Platform for Third-Party Exchange: For exchanging data with third parties not using specific Veeva connectors, consider leveraging underlying cloud platform capabilities (e.g., AWS Lambda and S3 storage) to automate data ingestion, transform data into Vault-loader-ready formats, and streamline the transfer process.
• Consider Veeva Platform Vault for Non-GxP Documents: For managing documents that don't fit neatly into existing development cloud vaults (e.g., legal contracts, budgets), explore Veeva's platform vault offering. This can provide a single platform and consistent user experience for both GxP and non-GxP content, but should be discussed with Veeva account managers.

Tools/Resources Mentioned:

• Veeva Vault (general platform)
• Veeva CRM
• Veeva Clinical (eTMF, CTMS, SSU, SiteConnect, MyVeeva Patient application)
• Veeva Regulatory (Submissions, Registrations)
• Veeva Quality (QualityDocs, QMS)
• Veeva PromoMats
• Amazon Web Services (AWS) functionality: Lambda, S3 storage
• Vault Loader

Key Concepts:

• Veeva Vault: A cloud-based content and data management platform specifically designed for the life sciences industry, offering various suites and applications.
• eTMF (electronic Trial Master File): A digital system for managing essential clinical trial documents, ensuring compliance and audit readiness.
• SSU (Study Startup): The phase of clinical trials involving all activities required to initiate a study, including site selection, contract negotiation, and regulatory approvals.
• CTMS (Clinical Trial Management System): Software used to manage and track various aspects of clinical trials, including participant enrollment, site performance, and study progress.
• Registrations: The process of tracking and managing product registrations with regulatory authorities worldwide.
• Submissions: The process of preparing and submitting regulatory documents (e.g., eCTD) to health authorities.
• SiteConnect: A Veeva solution that facilitates the secure exchange of documents and data between sponsor Veeva Vaults and investigator SiteVaults.
• Global Directory: A centralized repository within Veeva Vault for managing information about organizations, sites, and personnel, crucial for consistent data across applications.
• Country Intelligence: A feature within Veeva Vault that provides guidance and control for managing country-specific regulatory requirements and document collections.
• Master Data Management (MDM): A comprehensive method for defining and managing an organization's critical non-transactional data to provide a single point of reference.
• Change Advisory Board (CAB): A formal group responsible for reviewing, evaluating, authorizing, and prioritizing changes to IT services and infrastructure, including Veeva Vault configurations and releases.
• GxP, 21 CFR Part 11, FDA, EMA: Regulatory standards and authorities relevant to pharmaceutical and life sciences industries, emphasizing good practices (GxP), electronic records and signatures (21 CFR Part 11), and oversight by the Food and Drug Administration (FDA) and European Medicines Agency (EMA).