Quality & Compliance
Quality Assurance & Audits
Independent audits and quality oversight for sites, vendors, systems and processes.
What's Included
- GCP audits: investigator sites, systems and processes
- Vendor and CRO qualification and oversight audits
- TMF and clinical database audits
- Pharmacovigilance system audits
- GMP/GDP audits for manufacturers, depots and couriers
- Computer system validation (CSV) audits
- Laboratory (GCLP) audits
- For-cause audits and investigations
- Quality agreements and vendor oversight plans
- CAPA management and root-cause analysis
- Audit programs and annual audit plans