Close Icon

The Critical Elements of Continuous CRO Oversight

The CRO Oversight Plan is a guideline for the ClinOps team to ensure the vendor’s adherence to the Scope of Work (SOW), study-specific plans, processes, procedures, and GCP guidelines.  The development of a Quality Agreement and Oversight Plan documents the frequency and process for:

  • KPI Definition
  • Calculations
  • Thresholds
  • KPI Monitoring
  • Issue Management
  • Escalation

During this webinar, we covered a case study of a leading pharma company who automated their quality agreement and CRO oversight plan to meet imminent ICH E6 (R2) requirements.

Saama can put you on the fast track to clinical trial process innovation.