Vault Clinical Operations Suite for CROs

This video provides an in-depth exploration of Veeva's Vault Clinical Operations Suite, specifically highlighting its utility and benefits for Contract Research Organizations (CROs). The main purpose is to demonstrate how this unified cloud platform enhances efficiency, accelerates clinical trials, and positions CROs as strategic partners capable of delivering high-quality services to sponsors. The presenter, logged in as a study manager, walks through various functionalities, emphasizing how a single, integrated system can reduce complexity, ensure regulatory compliance, and provide comprehensive oversight across all stages of a clinical study.

The presentation begins by showcasing the unified nature of the platform, where studies, countries, and sites are set up once and then leveraged across different applications within the suite. This single-source approach streamlines operations, increases compliance, and ensures inspection readiness by integrating milestones and expected documents with built-in global intelligence and country-specific templates. The demonstration covers key operational aspects such as viewing enrollment metrics, visit definitions, and payment information, including how payable items can be automatically triggered by subject data. It also details the management of study personnel through a global directory, allowing for efficient reuse of personnel and organizations across multiple studies.

Further into the demonstration, the focus shifts to study startup and conduct. The presenter illustrates how the study startup homepage provides a consolidated view of site progress, greenlight approvals, submission milestones, and overall tasks. A critical feature highlighted is the ability to select quality sites based on historical performance data within Vault, including the review of surveys completed by non-Vault users and their scores for trending analysis. The video then transitions to the monitor's perspective, showing the lifecycle of a completed pre-study visit (PSV), the information gathered during monitoring events, and the automatic filing of confirmation letters, trip reports, and follow-up letters within the eTMF. Finally, the video touches upon study conduct, demonstrating how study managers can stay on top of tasks, monitor high-level metrics for sites and enrollment, and utilize centralized reports and dashboards that combine document and data metrics to provide sponsors with transparency and a full view of study performance, with the option to grant them direct access to these metrics within Vault.

Key Takeaways:

• Unified Cloud Platform for CROs: The Veeva Vault Clinical Operations Suite serves as a single, unified cloud platform designed to help CROs increase operational efficiency, speed up clinical trials, and become more strategic partners to sponsors by delivering high-quality services.
• Streamlined Setup and Reuse: Studies, countries, and sites only need to be set up once within the clinical operations vault, allowing for their utilization across various applications and reducing redundant data entry and complexity.
• Enhanced Compliance and Inspection Readiness: The system increases compliance by integrating milestones and expected documents, ensuring CROs are inspection-ready and compliant with evolving regulations through built-in global intelligence and country-specific templates.
• Automated Payment Triggers: Payable items at the site level can be automatically triggered based on incoming subject data, streamlining financial processes and ensuring timely payments.
• Centralized Personnel Management: Study personnel and organizations can be set up once in a global directory at the Vault level and then associated with specific studies, countries, or sites, allowing for efficient reuse across multiple studies.
• Comprehensive Study Startup Oversight: The study startup homepage provides a consolidated view of site startup progress, greenlight and submission milestones, and overall tasks, including a chart comparing actual versus planned site greenlight approvals.
• Data-Driven Site Selection: CROs can select quality sites based on historical performance data within Vault reports, and review surveys completed by non-Vault users and their scores for trending analysis, enabling informed decision-making.
• Integrated Monitoring Workflow: The platform supports the entire monitoring process, from scheduling pre-study visits (PSVs) to tracking their lifecycle states, capturing monitoring event information, and automatically filing confirmation letters, trip reports, and follow-up letters within the eTMF.
• Real-time Study Conduct Monitoring: Study managers can effectively manage tasks, view high-level metrics on sites and enrollment, and track outstanding tasks and milestones, with the ability to zoom in on specific time periods for detailed insights into completeness, timeliness, and quality.
• Transparent Performance Reporting for Sponsors: Centralized reports and dashboards provide a full view of study metrics, combining document and data metrics side-by-side, enabling CROs to better manage study performance and offer transparency to sponsors, including the option to grant sponsors direct access to these metrics within Vault.

Tools/Resources Mentioned:

• Veeva Vault Clinical Operations Suite: The core platform demonstrated, encompassing various applications for clinical trial management.
• Veeva eTMF: Mentioned as the repository for automatically filed monitoring documents like confirmation letters, trip reports, and follow-up letters.
• CTMS (Clinical Trial Management System): Implied as a component or integrated function within the suite, handling enrollment metrics and visit definitions.

Key Concepts:

• Unified Cloud Platform: A single, integrated system hosted in the cloud that consolidates various clinical operations functions, eliminating data silos and improving efficiency.
• Inspection Readiness: The state of being prepared to demonstrate compliance with regulatory requirements during an audit or inspection, facilitated by organized documentation and transparent processes.
• Global Intelligence: Built-in features, such as country-specific templates, that provide regulatory and operational guidance tailored to different regions, aiding compliance and standardization.
• Site Greenlight Approvals: Milestones indicating that a clinical trial site has met all necessary criteria and received approval to begin patient enrollment and study activities.
• Pre-Study Visit (PSV): An initial visit conducted by a monitor to a potential clinical trial site to assess its suitability and capabilities before study initiation.
• eTMF (Electronic Trial Master File): A digital repository for all essential documents related to a clinical trial, ensuring regulatory compliance and easy access to information.