Leveraging Your Veeva Vault Investment

This presentation provides an in-depth analysis of the technical and organizational complexities involved in leveraging and expanding an existing investment in the Veeva Vault platform, using a case study focused on integrating Study Startup (SSU) functionality into a deployed electronic Trial Master File (eTMF) Vault. The speaker details a scenario where a client faced rapid, overlapping project timelines—including an eTMF project, system integrations, SSU going live, and a legacy SSU data migration—all while the Vault platform itself was undergoing rapid change. This environment of high expectations and shifting priorities necessitated a holistic approach to implementation, emphasizing that changes to one functional area (like SSU) inevitably impact the configuration and users of the existing platform (eTMF).

A significant challenge highlighted was the complexity of the legacy data migration, which required early preparation despite being the last phase of deployment. The dynamism of the environment meant the team had to contend not only with legacy data anomalies but also with multiple internal data sources within the Vault itself. Technical hurdles included managing configuration triggers and auto-complete rules that interfered with migration progress, alongside ongoing activity from regular Vault releases. Organizationally, the client struggled with duplications and inconsistencies within the Global Directory for person and organization names, which required extensive data cleansing and the eventual imposition of Master Data Management (MDM) rules—a measure the client had previously resisted.

The necessity of strong, collaborative business leadership was presented as a critical success factor. Despite the shared ownership across multiple functional areas, the project succeeded due to business leads who maintained a clear vision for their functions and worked productively to manage change control requests and validation documentation. This cooperation was a "definite win," underscoring the need to select business owners who are strong collaborators. However, the lack of foresight regarding the SSU implementation led to substantial rework; the eTMF team had completed their configuration (including TMF index, milestone master sets, and EDLs) based solely on TMF needs, only to discover that SSU required new milestones, filing guidance changes, and reconsideration of existing EDLs from scratch.

Furthermore, the project utilized Veeva's Country Intelligence capability to address outstanding audit findings related to clarity and missing documents within country collections. Country Intelligence provided the necessary project progress tracking and a tool to assess document completion. The speaker strongly advised that implementing Country Intelligence correctly requires painstaking upfront analysis, exquisite attention to detail, and global colleague cooperation. The overarching lesson derived from the case study is the importance of consulting the product roadmap early to understand the timing of new functionality (like SSU) so that stakeholders can collaboratively build an appropriate foundational configuration for both the existing and new capabilities, thereby avoiding costly rework.

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Detailed Key Takeaways

• Holistic Planning is Mandatory for Platform Expansion: When adding new functional capabilities (e.g., SSU) to an existing platform (e.g., eTMF Vault), planning must be holistic, as technical and business considerations can affect all users and existing configurations, not just the function being newly supported.
• Early Migration Preparation is Crucial: Even if data migration is the final deployment phase, early preparation is essential to manage tight timelines and the dynamic nature of the environment, especially when dealing with legacy data anomalies and multiple data sources within the Vault itself.
• Master Data Management (MDM) is Non-Negotiable: The project faced significant challenges due to duplications and inconsistencies in the Global Directory (person and organization entries). Data cleansing and the enforcement of MDM rules, even if previously resisted by the client, are necessary prerequisites for successful migration and integration.
• Configuration Triggers Impact Migration: Technical elements like configuration triggers and auto-complete rules within the Vault can significantly impact the progress and outcome of data migration, requiring careful analysis and management during the planning phase.
• Strong Business Leadership Drives Validation Success: The success of validation and change control management relied heavily on strong business leads with clear functional visions who could work collaboratively across shared ownership areas to manage requests and documentation effectively.
• Anticipate Rework Without Roadmap Consultation: Failure to consult the Veeva product roadmap and anticipate the timing of new functionality (like SSU) led directly to substantial rework of the existing eTMF configuration, including the TMF index, milestone master sets, and Electronic Document Lists (EDLs).
• New Functionality Redefines Existing Configuration: The introduction of SSU quickly necessitated changes to the existing TMF filing guidance, new milestones, and new EDLs, demonstrating that new capabilities fundamentally alter the foundational configuration of the parent Vault.
• Country Intelligence Addresses Audit Gaps: Country Intelligence is a valuable tool for addressing audit findings related to document clarity and completeness within country collections, providing necessary project progress tracking and assessment capabilities.
• Implementing Country Intelligence Requires Rigor: Achieving success with Country Intelligence demands painstaking upfront analysis, exquisite attention to detail, and the cooperation of global colleagues to ensure accurate guidance and control are established.
• Select Business Owners Based on Collaboration: Project success is highly correlated with selecting business owners who possess strong collaborative personalities, enabling them to productively manage shared ownership and change control requests across different functional teams.

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Key Concepts

• Veeva Vault: A suite of cloud-based applications for content and data management across clinical, regulatory, quality, and commercial functions in the life sciences industry.
• eTMF (Electronic Trial Master File): A system used to manage essential clinical trial documents, ensuring compliance and inspection readiness.
• SSU (Study Startup): The process and associated Veeva module for initiating clinical trials, including site selection, contract negotiation, and regulatory submissions.
• EDLs (Electronic Document Lists): Lists defining the expected documents required for a clinical trial or specific milestone within the TMF.
• Master Data Management (MDM): A discipline focused on creating and maintaining a single, consistent, and accurate view of core business data (e.g., person and organization names) across the enterprise.
• Country Intelligence: A Veeva capability that provides guidance and control for document collection and progress tracking specific to regulatory requirements in different countries.