Medidata TSDV
More than 50% of site monitoring budgets are spent on source data verification (SDV). Yet verifying every data field rarely changes outcomes.
Medidata TSDV (Targeted Source Data Verification) focuses verification on critical safety and efficacy data in Rave EDC, helping you reduce unnecessary effort without compromising regulatory confidence.
SDV Built around Risk
TSDV turns SDV into a structured, risk-aligned strategy. You define what requires verification, at what level, and where, aligned to study-level risk assessments.
Built inside Rave EDC, it enables study- and site-specific SDV strategies while maintaining full coverage of critical safety and efficacy data.
Critical Data Focus
Inspection
Readiness
Study- and Site- Specific SDV
Field-level Verification
Reduced SDV Strategy in Practice
Lower Monitoring Cost
Control SDV-driven Monitoring Costs
Move away from 100% SDV and apply verification only where risk strategy requires it. By reducing unnecessary verification activity and site visits, you lower monitoring costs without compromising oversight.
Download Fact Sheet
Featured Resource
From 50% to Targeted 15–20% SDV
Nordic Bioscience replaced manual SDV tracking with Medidata TSDV and piloted true risk-based monitoring. The result: streamlined execution and a path toward 15–20% SDV with significant cost savings potential.
Read Case Study
FAQ
How does Medidata TSDV help reduce monitoring costs?
Medidata TSDV allows study teams to focus Source Data Verification (SDV) efforts on critical-to-quality data rather than 100% of the data. Since SDV often consumes over 50% of site monitoring budgets, this targeted approach significantly reduces the time CRAs spend on low-value data verification, lowering overall monitoring costs without compromising data quality.
Can we customize the SDV strategy for specific sites or studies?
Yes. Medidata TSDV offers the flexibility to configure study-specific and site-specific SDV plans. You can define verification requirements down to the specific data field, form, and patient visit level, allowing for a tailored strategy that fits the risk profile of each site.
Does Medidata TSDV support compliance with risk-based monitoring guidelines?
Yes. The solution is designed to support ICH GCP E6 (R2), E8 (R1), and (R3) compliance. It enables teams to apply a risk-based approach to clinical operations while automatically maintaining a complete, inspection-ready audit trail of exactly what was verified and what was not.
How does Medidata TSDV integrate with the rest of the study workflow?
Medidata TSDV is fully unified with Rave EDC and the broader Medidata Platform. This means CRAs are directed to the specific fields requiring verification directly within their workflow, and study managers have full visibility into SDV progress and assignments throughout the trial lifecycle.
Does Medidata offer training for its clients and partners?
Yes. Medidata offers a variety of training options for our clients and partners, including both self-paced and instructor-led courses. To learn more about available courses and to access our resources, please visit the Medidata Global Education and Training section.