Vault Study Startup Country Intelligence

This video provides an in-depth demonstration of how Veeva Vault Study Startup (SSU) addresses the complexity of maintaining accurate regulatory intelligence and standardizing clinical trial initiation processes across diverse global regions. The core problem addressed is the inefficiency and error-proneness associated with managing country-specific regulatory requirements and essential document tracking using traditional methods like spreadsheets. Vault Study Startup offers a standardized, centralized approach by managing two key aspects of country intelligence: required content (documents) and workflow processes (milestone sequencing).

The platform standardizes the required content by automatically adjusting the list of essential documents needed to complete a specific milestone based on the country where the site is located. For instance, the documents required for the "Essential Documents" milestone at a US site will differ from those required at a site in another country, reflecting local regulatory mandates. This automated differentiation eliminates the need for manual tracking and ensures that study teams are always working with the correct, country-specific documentation requirements. Beyond document tracking, the system tracks key dates, including planned and actual finish dates for each milestone, providing robust project management capabilities for clinical trial initiation.

The second critical component is the management of country-specific workflow processes, which dictates the sequence of milestones required for site activation. The video illustrates this using a comparison between the United Kingdom and Poland. In the UK, the "Ethics Approval" milestone can immediately follow the "Site Selected" milestone. However, in Poland, the regulatory sequence is different: a fully executed contract must be in place prior to seeking ethics approval. Vault SSU manages this by utilizing milestone sequencing logic. For the Polish site, the "Ethics Approval" milestone is hidden from the immediate next steps after site selection; instead, it appears only after the "Financial Documents" milestone (which includes contract execution) has been completed. This automated sequencing ensures regulatory adherence by enforcing the correct order of operations specific to each country's legal framework.

This country intelligence—encompassing both document requirements and workflow sequencing—is maintained and managed at a template level within Veeva Vault. These robust templates serve as a standardized starting point for startup and regulatory teams, which can then be reviewed, updated, and maintained by the client teams on an ongoing basis. Furthermore, Veeva actively updates the underlying country intelligence data whenever regulations change, providing SSU customers with access to the latest regulatory requirements, significantly reducing the burden of manual regulatory monitoring and ensuring continuous compliance throughout the study startup phase.

Key Takeaways: • Centralized Regulatory Intelligence: Veeva Vault Study Startup eliminates the reliance on error-prone spreadsheets for tracking country-specific regulatory requirements by centralizing required content and workflow logic within the platform. • Automated Document Requirements: The system dynamically adjusts the list of required essential documents for specific milestones based on the site's country, ensuring compliance with local regulations (e.g., US site requirements differ from other countries). • Milestone Sequencing for Compliance: Vault SSU uses sophisticated milestone sequencing logic to enforce country-specific regulatory processes, ensuring that steps are completed in the correct legal order. • Example of Workflow Differentiation: The platform demonstrates its intelligence by enforcing different sequences for ethics approval; in the UK, ethics approval follows site selection, but in Poland, a fully executed contract must precede ethics approval. • Tracking Key Dates: The system tracks both planned and actual finish dates for all milestones, providing essential data for project management, forecasting, and identifying potential bottlenecks in the study startup process. • Template-Based Standardization: Country intelligence data, including document and workflow sequencing requirements, is managed at a template level, offering a robust, standardized starting point that client teams can customize and maintain. • Veeva-Maintained Regulatory Updates: A significant value proposition is that Veeva updates the underlying country intelligence data as regulations change globally, allowing SSU customers to access the latest regulatory mandates without extensive manual monitoring. • Focus on Site Activation: The entire system is geared toward streamlining the path to site activation by providing clear, compliant, and sequential steps that regulatory and startup teams must follow.

Tools/Resources Mentioned:

• Veeva Vault Study Startup (SSU)

Key Concepts:

• Country Intelligence: The automated management of country-specific regulatory requirements, essential document lists, and workflow sequencing necessary for clinical trial initiation.
• Milestone Sequencing: The structural linking of milestones within a process to enforce a specific, required order of completion, ensuring regulatory adherence based on local laws (e.g., contract before ethics approval).
• Site Activation: The final stage of study startup where a clinical site is authorized and ready to begin screening and enrolling patients.