GCP Auditing Services
Practical, risk-focused GCP auditing for biotech, pharma, CROs, and clinical sites
Clinovare provides Good Clinical Practice (GCP) auditing services tailored to the needs of small to mid-size biotech and pharmaceutical sponsors, CROs, and clinical research sites. Our audits are practical, risk-based, and focused on improving compliance while supporting inspection readiness.
We conduct audits with a collaborative mindset, identifying gaps early and providing clear, actionable recommendations rather than generic findings.
Audit Types
- Clinical site GCP audits
- CRO and vendor audits
- Sponsor system and process audits
- Trial-specific audits (ongoing or close-out)
- Inspection readiness and pre-inspection audits
Audit Scope Includes
- ICH-GCP compliance and regulatory requirements
- Subject safety and informed consent processes
- Protocol adherence and deviation management
- Data integrity and source documentation
- TMF and essential document completeness
- CAPA development and follow-up support
Best Fit When
- Organizations want an objective, independent compliance assessment
- Preparing for regulatory inspections or due diligence
- Identifying and mitigating compliance risks early
- Supporting quality improvement initiatives
Interested in GCP Auditing Services?
If you're preparing for inspections or strengthening your quality program, you can contact us directly to discuss a tailored audit plan.