Veeva SiteVault Demo: Save Time and Reduce Tech Overload

This video provides an in-depth demonstration and discussion of Veeva SiteVault, a free e-regulatory system designed for clinical research sites. The presentation, featuring Bree Burks from Veeva and host Brad, focuses on how SiteVault helps research sites save time, reduce technological burden, improve compliance, and facilitate seamless information exchange with sponsors and Contract Research Organizations (CROs). The core purpose is to showcase SiteVault's foundational features, emphasizing its role in digitizing regulatory documents and streamlining clinical trial operations, moving away from paper-based or disparate electronic systems.

The discussion progresses from SiteVault's user interface, highlighting the automated task management system that prioritizes actionable items across multiple studies. A significant portion is dedicated to the e-binder, which provides a standardized, auto-generated structure for regulatory documents. This standardization is presented as a crucial element for efficiency and quality, reducing the common problem of inconsistent document filing. The demo illustrates practical functionalities such as document routing, version control with a "version compare" feature to identify changes, electronic signatures for key documents like CVs, and the ability to reuse documents (e.g., lab certifications, CVs) across multiple studies and locations.

A key focus of the video is on improving the monitoring process and sponsor-site interactions. SiteVault enables "e-monitoring," allowing remote or on-site monitors secure, scheduled access to only the necessary and finalized documents, eliminating the need for manual preparation or physical document handling. The system also provides dashboards that offer insights into monitoring activity, document pass rates, and site efficiency, helping sites identify bottlenecks and justify resource allocation. The latter part of the demo introduces "Study Connect," a feature that directly links a site's SiteVault e-regulatory system with a sponsor's Veeva system, enabling mapped, standardized document exchange, safety letter distribution, e-consent, and electronic patient-reported outcomes (ePRO). This aims to reduce transactional communication, email clutter, and duplication of effort, fostering better relationships and operational efficiency between sites and sponsors.

The speakers emphasize that SiteVault is not merely a shared drive but a purpose-built system designed to address the inherent inefficiencies in clinical research document management. They highlight how the system's baked-in processes and standards can transform site operations, from individual document workflows to broader organizational management, including support for Site Management Organizations (SMOs) with multiple locations. The conversation also touches upon Veeva's broader vision for a holistic site experience, integrating various Veeva technologies (like RTSM, EDC, study training) to create a more unified platform for sites interacting with sponsors.

Key Takeaways:

• Automated Task Management: SiteVault provides a centralized dashboard for actionable tasks across all studies, automatically identifying documents needing attention (e.g., new versions, comments, training evidence), which helps sites prioritize work and manage staff availability.
• Standardized e-Binder Structure: The system offers an auto-generated, consistent folder and subfolder structure for regulatory documents across all studies. This standardization reduces variation, improves quality, and simplifies training for monitors and site staff, even if initial site preferences differ.
• Efficient Document Management: Users can route documents, create new versions, add/remove annotations, and perform document-specific actions (e.g., e-signatures, setting as current version) directly from the e-binder, minimizing clicks and navigation.
• Automated Document Naming and Classification: When uploading documents like lab certifications, SiteVault can automatically classify and name them, and users can tie these documents to specific organizations for reuse across multiple studies, eliminating redundant uploads.
• Cross-Study Document Management: Key documents like investigator CVs can be managed centrally. When a PI signs an updated CV, the system automatically distributes the most current version to all relevant studies, preventing manual filing and ensuring consistency.
• Version Compare for Document Changes: SiteVault offers a "version compare" feature that visually highlights changes (additions in purple, deletions in red) between document versions, eliminating the "track change nightmare" and quickly showing what has been updated.
• Secure e-Monitoring: The system allows sites to schedule secure, role-based access for monitors (remote or on-site), ensuring they only see finalized, relevant documents (e.g., no budgets/contracts). This streamlines monitoring preparation and reduces site burden.
• Monitoring Activity Dashboards: SiteVault provides self-service dashboards for monitors and sites, showing documents awaiting site response, new documents available for review, and "pass rates" (how often documents pass review the first time). These metrics offer insights into internal quality and monitoring efficiency.
• Study Connect for Seamless Sponsor-Site Exchange: This feature enables a direct, mapped connection between a site's SiteVault and a sponsor's Veeva system, facilitating standardized document exchange, safety letter distribution, e-consent, and ePRO. This reduces email communication, portal fatigue, and duplication.
• Comprehensive Document Exchange History: Study Connect maintains a complete history of all documents sent and received between the site and sponsor, providing an audit trail that is invaluable for audits, staff turnover, and understanding communication flow.
• Support for Site Management Organizations (SMOs): SiteVault is designed to support multiple site locations, allowing SMOs to manage regulatory documents across all their sites with consistency and roll up insights across the entire network.
• Focus on Process over Simple Storage: The platform is highlighted as a purpose-built regulatory system, not just an electronic share drive. It embeds industry processes and workflows to address inherent inefficiencies, aiming to improve relationships between sites, sponsors, and monitors by reducing transactional interactions.
• Free Product with Extensive Resources: Veeva SiteVault is a free product for sites, and Veeva provides comprehensive free support, including quick videos, live training, group training, and site success managers with research backgrounds, along with SOP templates and reference models.

Tools/Resources Mentioned:

• Veeva SiteVault: The primary e-regulatory system demonstrated.
• Veeva Study Connect: A feature within SiteVault for sponsor-site document and information exchange.
• Veeva CRM: Mentioned as a platform IntuitionLabs.ai provides consulting for, and Veeva's broader presence in the industry.
• Veeva RTSM, EDC, Study Training: Other Veeva technologies that are part of the broader vision for a holistic site experience.
• My Veeva for Patients app: A patient portal synced with SiteVault for patient-facing interactions and notifications.
• sites.viva.com: Website for resources, videos, and sign-up for Veeva SiteVault.

Key Concepts:

• e-Regulatory System (e-reg): A digital system for managing and storing all regulatory documents required for clinical trials, replacing paper binders.
• e-Binder: The digital equivalent of a physical regulatory binder, structured within SiteVault.
• e-Monitoring: The process of monitors (CRAs) reviewing site documents electronically, often remotely, through a secure system like SiteVault.
• Version Compare: A feature that automatically identifies and highlights changes between different versions of a document.
• Study Connect: A module that facilitates direct, mapped data and document exchange between a site's e-regulatory system and a sponsor's clinical trial management systems.
• Consumer-Grade Experience: The design philosophy for Study Connect, aiming for ease of use and intuitiveness comparable to popular consumer applications like Amazon, requiring minimal training.
• Variation is the Enemy of Quality: A principle cited to justify the standardized structure of the e-binder, arguing that consistency improves quality and efficiency.
• Transactional Nature of Interactions: The common problem in clinical research where interactions between sites, sponsors, and monitors are often focused on deadlines, document requests, and administrative tasks rather than strategic collaboration.