TSDV

Medidata TSDV (Targeted Source Data Verification) is a risk-based monitoring solution built for clinical trial teams seeking to reduce the cost and effort of source data verification without compromising data quality or regulatory confidence. With more than 50% of site monitoring budgets typically consumed by SDV, Medidata TSDV enables study teams to move away from 100% verification and focus only on critical safety and efficacy data — all within the Rave EDC environment.

Designed for sponsors, CROs, and clinical research associates (CRAs), Medidata TSDV transforms SDV into a structured, risk-aligned strategy. Teams can define exactly what requires verification, at what level, and where, in alignment with study-level risk assessments. The solution supports both study-specific and site-specific SDV plans, ensuring full coverage of critical data while eliminating unnecessary verification activity.

Core Capabilities

• Critical data focus: Directs verification efforts toward data fields that are critical to quality, safety, and efficacy rather than applying blanket 100% SDV across all data points.
• Study- and site-specific SDV strategies: Allows configuration of tailored SDV plans at the study and individual site level, accommodating the unique risk profile of each site.
• Field-level verification: Verification requirements can be defined down to the specific data field, form, and patient visit level for granular control.
• Inspection readiness: Automatically maintains a complete, inspection-ready audit trail documenting exactly what was verified and what was not, supporting regulatory review at any time.

Risk-Based Monitoring in Practice

• Lower monitoring costs: By reducing unnecessary verification activity and limiting low-value site visits, TSDV significantly decreases overall monitoring expenditure without sacrificing oversight.
• Prioritize critical data: CRAs are directed within their workflow to the specific fields requiring verification, ensuring effort is concentrated where it matters most.
• Adjust to risk: SDV strategies can be adapted dynamically to reflect the evolving risk profile of a study or site throughout the trial lifecycle.
• Proven results: Nordic Bioscience replaced manual SDV tracking with Medidata TSDV and piloted true risk-based monitoring, achieving a path toward 15–20% SDV with significant cost savings potential, down from a previous baseline of 50%.

Regulatory Compliance Support

• Designed to support compliance with ICH GCP E6 (R2), E8 (R1), and E8 (R3) guidelines.
• Enables teams to apply a risk-based approach to clinical operations in line with current regulatory expectations for risk-based monitoring.
• Maintains a full audit trail of SDV activity to ensure inspection readiness throughout the trial.

Integration and Workflow

• Fully unified with Rave EDC and the broader Medidata Platform, embedding TSDV directly into the existing CRA and study manager workflow.
• Study managers have full visibility into SDV progress and assignments throughout the trial lifecycle.
• CRAs are guided directly to fields requiring verification within their standard workflow, reducing manual coordination and oversight gaps.

Medidata TSDV is part of the broader Medidata Platform, which encompasses data, study, and patient experiences alongside professional services. Medidata also provides a range of training options — including self-paced and instructor-led courses — through its Global Education and Training program to support client and partner adoption of the solution.