Accelerate time to site activation with Vault Study Startup

This video provides an in-depth exploration of the challenges inherent in clinical trial study startup and introduces Veeva Vault Study Startup as a specialized solution designed to accelerate site activation. The presentation begins by establishing the high cost and complexity associated with managing study startup activities manually, often relying on disparate spreadsheets and emails. This fragmentation makes it difficult for clinical operations teams to determine the critical path for a study, leading to delays that can cost pharmaceutical companies up to $2 million per month. The core purpose of the application is to streamline these processes, ensuring the rapid identification and activation of suitable trial sites.

The solution, Veeva Vault Study Startup, focuses on creating a unified, intuitive interface for managing the entire process. Users gain access to a personalized study startup homepage that provides a comprehensive view of all studies and milestones, clearly outlining daily priorities and tasks. This centralization is crucial for identifying and resolving operational bottlenecks quickly, facilitating collaboration among team members from a single source of truth. The platform addresses a significant pain point in the site selection process by enabling the direct distribution of feasibility surveys from within the application, thereby eliminating the manual effort and wasted hours typically spent reconciling survey results from external sources.

The video emphasizes the platform's utility for global studies through the inclusion of built-in workflows and country-specific milestones, which are essential for navigating diverse regulatory and operational requirements worldwide. The acceleration of the site activation process is further supported by real-time dashboards and reports, providing immediate progress tracking and enabling data-driven decision-making. Crucially, Vault Study Startup is positioned within Veeva's unified suite of clinical operations applications, ensuring seamless information exchange and integration with related systems such as the Clinical Trial Management System (CTMS) and the electronic Trial Master File (eTMF). This integration improves overall collaboration and increases operational efficiency, ultimately helping to get therapeutic products to patients faster.

Key Takeaways: • High Cost of Delay: Delays in clinical trial study startup are extremely costly, potentially reaching $2 million per month, underscoring the necessity of optimizing site activation timelines and identifying the critical path quickly. • Centralized Management: The platform replaces fragmented tracking methods (spreadsheets and emails) with a single, intuitive interface, offering a full view of studies, milestones, and daily priorities to minimize complexity and friction. • Personalized Workflow: A personalized study startup homepage allows users to see their specific tasks and priorities, enabling efficient task completion and immediate identification of issues or bottlenecks requiring action. • Automated Feasibility Surveys: The system eliminates the manual burden of site selection by allowing teams to send feasibility surveys directly from the application, drastically reducing the time spent reconciling results and identifying the right sites. • Global Study Acceleration: The application supports complex global trials by incorporating built-in workflows and country-specific milestones, ensuring compliance and accelerating the site activation process across different jurisdictions. • Real-Time Visibility: Real-time dashboards and reports provide immediate tracking of site activation progress, enabling clinical operations teams to make better, more informed decisions based on current data rather than outdated reports. • Unified Clinical Ecosystem: Vault Study Startup is integrated into Veeva’s unified suite of clinical operations applications, facilitating seamless information sharing across core systems like CTMS and eTMF, which enhances collaboration and operational efficiency. • Focus on Bottleneck Resolution: The centralized interface is specifically designed to help users quickly find and resolve issues and bottlenecks that traditionally slow down the study timeline, ensuring the critical path remains clear.

Tools/Resources Mentioned:

• Veeva Vault Study Startup
• Veeva Vault CTMS (Clinical Trial Management System)
• Veeva Vault eTMF (electronic Trial Master File)

Key Concepts:

• Study Startup: The initial phase of a clinical trial that encompasses site selection, regulatory document submission, contract negotiation, and site activation before patient enrollment can begin.
• Site Activation: The formal process of granting a clinical trial site permission to begin study activities, typically following regulatory approval and completion of all necessary documentation and training.
• Critical Path: The sequence of dependent activities in a project (like study startup) that determines the shortest possible time needed for completion; delays on the critical path directly extend the overall study timeline.
• Feasibility Surveys: Questionnaires sent to potential clinical sites to assess their capability, resources, patient population access, and interest in participating in a specific clinical trial.