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.

 
 
 
 
 
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Wistia video thumbnail - The Critical Elements of Continuous CRO Oversight
 

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