Edge Targeted SDV

Edge Targeted Source Document Verification (Edge Targeted SDV) lets you reduce SDV without sacrificing data quality or regulatory compliance.

Reduce Costly Verification, Keep Data Quality

Source Document Verification (SDV) devours more than 15 percent of trial budgets, yet research shows that verifying every data point does not significantly improve data quality. What if instead you could automatically target SDV where you need it most?

Edge Targeted SDV (formerly Targeted SDV) lets you reduce SDV coverage without sacrificing data quality or regulatory compliance.

Features and Benefits

With Edge Targeted SDV you can:

  • Save money on site monitoring. Edge Targeted SDV supports your risk-based monitoring strategy by recognizing at-risk data. Just plug in your critical variables, such as adverse events. When an abnormal value appears, Edge Targeted SDV adjusts SDV coverage automatically.
     
  • Save time for data managers and clinical research associates. Quickly configure SDV coverage levels at setup, or even make mid-trial adjustments, without programming. Edge Targeted SDV automatically assigns patients to the SDV level you preset. And CRAs work in the same EDC system they already use. So there’s no retraining, just better use of their time.
     
  • Maintain compliance. As part of the Medidata Clinical Cloud, Edge Targeted SDV harnesses the robust audit trail capabilities of Medidata's Rave EDC. Stay compliant with change controls for management and complete audit capabilities.

INC Research talks about Edge Targeted SDV

Carmen Weese, SVP, Data Operations at INC Research talks about Risk Based Monitoring using Edge Targeted SDV.

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Additional Resources

White Paper

Why Monitoring Is More Than Just SDV

Case Study

Nordic Bioscience Targets 20 Percent SDV With Risk-Based Monitoring

Infographic

RISK-BASED MONITORING: How To Know If It’s Right For Your Study