Clinical Operations
- Selection of CRO
- Vendor Oversight
GCP Auditing (FDA and ICH GCP)
- Investigator Site Audits
- Phase 1 Facility Audits
- Clinical Vendor Audits (CROs)
- Mock Inspections
- Essential Documents and Trial Master File (TMF) Audits
- Electronic Trial Master File (eTMF) Audits
- Clinical Trial Audits