End to End Trials with Vault CTMS

This video provides an in-depth exploration of Veeva Vault CTMS (Clinical Trial Management System), showcasing its capabilities for end-to-end management of clinical trials within the life sciences industry. The presentation highlights how Vault CTMS, as part of the broader Vault Clinical Suite, unifies clinical information, streamlines processes, and offers comprehensive visibility across the entire clinical trial portfolio. The speaker emphasizes the system's ability to provide actionable data and tasks directly upon login, ultimately enabling faster and more compliant trials.

The demonstration begins by illustrating the perspective of a trial manager, who gains immediate insights into trial activity through a role-specific dashboard. This dashboard presents critical metrics such as subject enrollment values against planned targets, the status of trip report completion, a clear view of clinical milestones with drill-down capabilities, and a graphical representation of subject status over time compared to forecasts. The video then transitions to the study's profile page, detailing how users can track the study's life cycle, build out the study team roster, and manage data access permissions. A key feature discussed is the integrated risk assessment functionality, which allows leveraging pre-existing risks from a library and assessment templates, facilitating easy adjustments and generating a document readout to the Trial Master File (TMF) with an automatically calculated risk score.

Further into the presentation, the focus shifts to the operational aspects of trial execution, particularly for site monitors and Clinical Research Associates (CRAs). After study setup, site monitors receive their own dedicated homepage, tailored with metrics relevant to their assigned sites and planning for upcoming visits. This includes key date information, enrollment tracking, their monitoring plan, and trending issues logged for specific sites. The system facilitates daily tasks, such as generating new records or drilling into data like communication logs and TMF-filed documents. The video meticulously walks through the CRA's workflow for authoring a trip report, demonstrating how all necessary information is readily available for compliant completion, including adding visits to calendars, capturing attendees, and performing Source Document Verification (STV) directly in Vault EDC via a linked interface. The seamless connection ensures STV data and deviations are transferred back to Vault CTMS in near real-time. Finally, the system prompts users with help text or required information during report completion, ensuring data quality and completeness, with all details logged against the site and included in the trip report. The process concludes with a collaborative review and approval workflow, where study managers or lead CRAs can leave annotations before manager approval, which automatically creates a trip report document in the TMF, immediately accessible to TMF users. The video concludes by emphasizing the system's ability to aggregate all records and activities into comprehensive reports and dashboards, providing insights into trial metrics, document and data collection, cycle times, and compliance values against the monitoring plan.

Key Takeaways:

• Centralized Clinical Trial Management: Veeva Vault CTMS acts as a unified platform for managing all aspects of clinical trials, integrating data and processes across various functions to provide a single source of truth.
• Role-Specific Dashboards for Enhanced Visibility: The system offers tailored dashboards for different user roles, such as trial managers and site monitors, providing immediate, relevant insights into trial activity, subject enrollment, milestone progress, and site-specific metrics.
• Automated Data Tracking and Forecasting: Vault CTMS automates the tracking of critical metrics like planned versus actual subject enrollment, leveraging feeds from EDC systems, and provides graphical representations of subject status over time compared to forecasts.
• Integrated Risk Assessment and Management: The platform includes a robust risk assessment feature, allowing users to track and reuse risks from a central library, utilize assessment templates, and automatically calculate risk scores, which are then documented in the TMF.
• Seamless Integration with Veeva Clinical Suite: The video highlights the inherent data sharing capabilities within the Vault Clinical Suite, specifically demonstrating near real-time data transfer between Vault CTMS, Vault EDC (Electronic Data Capture), and the TMF (Trial Master File).
• Streamlined Site Monitoring Workflows: Site monitors benefit from dedicated homepages that organize key date information, enrollment tracking, monitoring plans, and trending issues, facilitating efficient planning and execution of site visits.
• Compliant Trip Report Authoring and Approval: CRAs can author trip reports with all necessary information at their fingertips, ensuring compliant completion. The system supports capturing attendees, performing STV via direct links to Vault EDC, and includes help text and required fields to ensure data quality.
• Automated TMF Document Creation: Upon manager approval, trip reports are automatically created as documents within the TMF side of Vault Clinical's shared database, ensuring immediate availability and accessibility for TMF users.
• Collaborative Review and Annotation: The system supports collaborative workflows, allowing study managers or lead CRAs to leave in-line annotations on authored reports, which are reviewed and resolved before final manager approval.
• Comprehensive Reporting and Compliance Tracking: All trial records and activities can be aggregated into comprehensive reports and dashboards, offering insights into trial metrics, document and data collection, cycle times, and compliance against monitoring plans.
• Efficiency and Regulatory Adherence: The overarching benefit of Vault CTMS is its ability to streamline clinical operations, reduce manual effort, enhance data visibility, and ensure adherence to regulatory standards throughout the trial lifecycle.

Tools/Resources Mentioned:

• Veeva Vault CTMS
• Veeva Vault Clinical Suite
• Veeva Vault EDC (Electronic Data Capture)
• Veeva Vault TMF (Trial Master File)

Key Concepts:

• CTMS (Clinical Trial Management System): A software system used by pharmaceutical and biotechnology companies to manage and track the progress of clinical trials.
• EDC (Electronic Data Capture): A computerized system designed for collecting clinical trial data in an electronic format.
• TMF (Trial Master File): A collection of essential documents that individually and collectively permit the evaluation of the conduct of a clinical trial and the quality of the data produced.
• STV (Source Document Verification): The process of comparing data entered into the EDC system with the original source documents to ensure accuracy and completeness.
• Risk Assessment: The process of identifying, analyzing, and evaluating risks associated with a clinical trial to minimize potential negative impacts.
• Clinical Milestones: Key events or achievements in the clinical trial timeline, such as first patient in, last patient out, or database lock.
• Trip Reports: Documents prepared by CRAs after site visits, detailing observations, issues, and actions taken during the visit.