Our Experience

Investigator Site Audits – Case Study

For System Demo and further information, please call +91 98100 68241 or mail us at bd@crqa.in

Recent Projects

  • GCP audit of the CRO and the investigator sites for a leading European medical device company. Critical findings led to the termination of the CRO.
  • GCP audit of the leading global CRO.
  • For Cause’ Audit on behalf of a big pharma of the global investigator site, prior to USFDA inspection.
  • Preparation of end-to-end SOPs for Clinical Data Management and Biostatistics of the leading CRO conducting global studies, including GCP Training for regulatory inspection preparedness.
  • Over 100 GCP Training Programs for CROs, Investigator Sites, and Pharmaceutical companies.
  • IMP Depot audit.
  • Pharmacovigilance QA SOPs preparation for the leading CRO.
  • Pharmacovigilance LPVRP SOPs preparation for the Asia Pacific Region.
  • GMP Audit of an Indian pharma manufacturing facility on behalf of a leading global NGO.
  • Ethics Committee Formation, Regulatory Compliances, and Training.
  • Pre-inspection GLP training.