Alice Foltyn | Vault CDMS to Clinical Operations Connection - Register for Summit on October 14

This video provides an introductory overview of a specialized session presented by Alice Foltyn at the Veeva R&D and Quality Summit, focusing on the critical integration point between Veeva Vault Clinical Data Management Suite (CDMS) and Veeva Vault Clinical Operations (ClinOps). The primary objective of the session is to demonstrate how connecting these two essential components of the clinical trial ecosystem can significantly boost productivity. The discussion centers on leveraging the "Vault Unified" experience—a foundational concept within the Veeva platform—to manage complex, bi-directional data flows seamlessly, thereby bridging the gap between study management activities and the actual collection and cleaning of clinical data.

The core mechanism explored is the establishment of robust, bi-directional data pipelines between the CDMS and ClinOps vaults. In traditional clinical environments, data often resides in silos, requiring manual reconciliation or complex, custom integrations between the EDC (Electronic Data Capture, often handled by CDMS) and the CTMS (Clinical Trial Management System, handled by ClinOps). By utilizing the native integration capabilities of the Vault Unified platform, the system can automatically synchronize key information. This synchronization allows operational teams (ClinOps) to have real-time visibility into data collection progress, query status, and data quality metrics managed by the data management teams (CDMS). Conversely, data management teams benefit from immediate access to operational metrics, such as site activation status, patient enrollment figures, and monitoring visit schedules, which are crucial for planning data cleaning cycles and resource allocation.

The ultimate goal of this integration is the streamlining of end-to-end clinical processes. By connecting study management—which encompasses planning, site monitoring, and regulatory document management—with clinical data activities—such as CRF design, data entry, query management, and database lock—organizations can achieve faster cycle times and reduce the risk of errors associated with manual data transfer and reconciliation. This unified approach directly supports faster data review cycles, more efficient source data verification (SDV) planning, and improved oversight of the entire trial lifecycle, reinforcing the value proposition of a fully integrated, compliant technology stack for life sciences companies.

Key Takeaways: • Achieving True Clinical Unification: The session emphasizes that connecting Vault CDMS and Vault ClinOps is essential for realizing the full benefits of the Veeva Vault platform, moving beyond siloed systems to a single source of truth for both operational and clinical data. • Enabling Bi-directional Data Flow: The integration facilitates the automatic exchange of data points, ensuring that updates made in the CDMS (e.g., data query status) are immediately reflected in ClinOps (e.g., monitoring reports), and vice versa (e.g., site visit schedules impacting data review timelines). • Boosting Clinical Productivity: By automating the data exchange between these two critical functions, organizations can drastically reduce manual effort required for data reconciliation, status tracking, and reporting, leading to faster trial execution and database lock. • Real-time Operational Visibility: ClinOps teams gain immediate, accurate insight into the progress of data collection and cleaning, allowing for proactive adjustments to monitoring schedules, resource deployment, and risk-based quality management (RBQM) strategies. • Streamlining Study Management: The connection simplifies the management of clinical trials by linking the study protocol and site details (managed in ClinOps) directly to the data capture forms and cleaning processes (managed in CDMS). • Enhanced Regulatory Compliance: A unified system simplifies audit trails and ensures data integrity, as all operational and clinical data are managed within a single, compliant, validated environment, crucial for meeting GxP and 21 CFR Part 11 requirements. • Optimizing Source Data Verification (SDV): Real-time data quality metrics from CDMS can inform ClinOps teams precisely where and when SDV efforts should be focused, enabling a more efficient and targeted approach to monitoring. • Foundation for AI/LLM Solutions: The establishment of clean, unified data pipelines between CDMS and ClinOps is a prerequisite for deploying advanced AI and LLM tools, such as intelligent automation for query generation or predictive analytics for trial risk assessment. • Strategic Consulting Opportunity: For consulting firms, this integration point represents a high-value service area, requiring specialized expertise in both Veeva Clinical Suite configuration and data engineering to ensure optimal bi-directional flow setup and performance tuning.

Tools/Resources Mentioned:

• Veeva Vault CDMS (Clinical Data Management Suite): The platform used for electronic data capture (EDC), data cleaning, query management, and database lock.
• Veeva Vault Clinical Operations (ClinOps): The suite used for managing clinical trial processes, including CTMS (Clinical Trial Management System), eTMF (electronic Trial Master File), and study start-up.
• Vault Unified: The overarching framework that allows different Veeva Vault applications to communicate and share data seamlessly, eliminating data silos.

Key Concepts:

• Bi-directional Data Flows: The continuous, automated exchange of information between two systems, where data changes in System A are reflected in System B, and changes in System B are reflected back in System A.
• CDMS to ClinOps Connection: The specific integration focusing on linking clinical data collection and cleaning activities with operational management activities like monitoring, site visits, and regulatory document tracking.