Unified Vault eTMF and Vault CTMS Demo

This video provides an in-depth exploration of the unified Veeva Vault eTMF and Vault CTMS solution, demonstrating how combining these critical clinical trial management systems into a single application enhances operational efficiency and ensures robust evidence of compliance. The presentation highlights the elimination of data silos between the Trial Master File (TMF) and Clinical Trial Management System (CTMS), streamlining end-to-end clinical trial processes from study startup through execution and monitoring. The speaker's approach is highly demonstrative, walking viewers through various features and workflows within the integrated platform.

The demonstration begins by showcasing the TMF viewpoint and homepage, emphasizing how TMF users can actively manage inspection readiness for each study. This is achieved through the utilization of milestones and expected documents, which clearly highlight missing documents and allow for the tracking of trending quality issues or assigned tasks. The video then transitions to the shared study profile page, illustrating how a single record provides immediate access to study data collected from both TMF and CTMS, ensuring consistency and accessibility across both functional areas. This shared profile also serves as the central hub for building out the study team roster, defining personnel roles, and managing security around user access to the trial and its related information.

As the trial progresses into planning efforts, the video demonstrates the combined workflow across both applications. CTMS users can plan enrollment metrics by type, while TMF users plan expected content lists. The system facilitates the calculation of actual enrollment values by integrating data from Electronic Data Capture (EDC) systems, allowing for granular tracking on a monthly or weekly basis. From the TMF perspective, milestones and expected document lists are released according to trial time points, with the ability to update templates based on study specifics. Crucially, documents sourced from CTMS activities, such as monitoring reports, are included in these requirements. The platform simplifies document management by allowing TMF users to quickly identify missing documents and upload them via drag-and-drop, which pre-fills metadata points and routes documents through quality review workflows, tracking quality items as tasks and through trend reports.

The demonstration then shifts to the CTMS side, focusing on the Clinical Research Associate (CRA) experience. CRAs are provided with a dedicated landing page tailored to their job function, enabling them to manage site activity and subject statuses directly from EDC data. This page streamlines the planning and authoring of monitoring trip reports, automatically populating data from the system, such as visit participants from the team roster and subject data from connected Vault EDC. The system guides CRAs through response sections with help text and conditional record creation prompts. Upon completion of the review and e-signature workflow, Vault systematically generates the trip report document, immediately filing it to the TMF classification structure and counting it against expected document items, thereby eliminating the need for manual transfer to a separate system. This complete harmonization of Veeva Vault eTMF and CTMS into one system and database significantly enhances the ease and speed of the overall clinical process.

Key Takeaways:

• Unified System for Efficiency and Compliance: Combining Veeva Vault eTMF and CTMS into a single application significantly improves operational efficiencies by eliminating data silos and providing a unified view of clinical trial data, which is critical for demonstrating compliance.
• Proactive Inspection Readiness: The platform enables active management of inspection readiness through features like milestones and expected document lists, allowing users to quickly identify and address missing documents and track quality issues.
• Centralized Study Profile: A shared study profile page acts as a single source of truth for all study data, accessible to both TMF and CTMS users, ensuring data consistency and simplifying information retrieval.
• Integrated Planning Workflows: The system combines planning efforts, allowing CTMS users to plan enrollment metrics and TMF users to plan expected content lists within the same application, fostering better coordination.
• Automated Data Integration: Actual enrollment values are automatically calculated by feeding data from Electronic Data Capture (EDC) systems into the CTMS, providing real-time insights and reducing manual data entry.
• Streamlined Document Management: Users can easily identify missing documents, upload them via drag-and-drop with automatic metadata pre-fill, and route them through various workflow channels, including quality reviews, ensuring proper documentation and tracking.
• Real-time Quality Tracking and Resolution: Quality items are immediately sent as tasks and tracked through trend reports, helping identify lags in resolution and trending types of issues, which is crucial for maintaining trial integrity.
• CRA-Centric Workflows: Clinical Research Associates (CRAs) benefit from a dedicated landing page and guided workflows for authoring monitoring trip reports, with automatic data population from other connected systems like Vault EDC and the team roster.
• Automated Trip Report Generation and Filing: Upon completion and e-signature, the system systematically generates trip report documents and immediately files them to the correct TMF classification structure, simultaneously counting them against expected documents, eliminating manual transfer and ensuring compliance.
• Enhanced Security and Access Control: The platform allows for granular management of security and user access to the trial and its related information, ensuring that only authorized personnel can view or modify sensitive data.
• Elimination of Silos for Speed: The full harmonization of eTMF and CTMS into one system and database allows for unprecedented ease and speed in managing the overall clinical process, reducing administrative burden and accelerating trial execution.

Tools/Resources Mentioned:

• Veeva Vault eTMF
• Veeva Vault CTMS
• Veeva Vault EDC (as a data source)

Key Concepts:

• eTMF (electronic Trial Master File): A system designed to manage and store essential documents and records related to a clinical trial in an electronic format, ensuring regulatory compliance and inspection readiness.
• CTMS (Clinical Trial Management System): A software system used by pharmaceutical and biotechnology companies to manage and track the operational aspects of clinical trials, including study planning, site management, subject enrollment, and monitoring.
• Inspection Readiness: The continuous state of preparedness for regulatory inspections, ensuring that all trial documentation is complete, accurate, and readily accessible for review.
• Milestones: Significant events or achievements in the clinical trial timeline that serve as progress markers and often trigger specific actions or document requirements.
• Expected Documents: A predefined list of documents anticipated to be generated and filed at various stages of a clinical trial, crucial for tracking completeness and compliance.
• EDC (Electronic Data Capture): A system used to collect clinical trial data from participating sites directly into an electronic format, replacing paper-based methods and improving data quality and efficiency.
• CRA (Clinical Research Associate): A professional responsible for monitoring the conduct of clinical trials at investigator sites, ensuring adherence to the protocol, Good Clinical Practice (GCP), and regulatory requirements.
• Monitoring Trip Reports: Documents prepared by CRAs after site visits, detailing observations, findings, actions taken, and follow-up items related to the trial's progress and compliance at a specific site.