Audit Services
Clinical research quality audit services
Independent GCP audits across the full trial lifecycle — scoped to your risk, timelines and regulatory exposure.
Sponsor & Internal GCP Audits
Independent audits of your QMS, processes and study oversight to surface systemic risk before a regulator does.
Learn moreInvestigator-Site Audits
On-site or remote review of consent, source data, drug accountability and protocol adherence to protect data integrity.
Learn moreCRO & Vendor Qualification Audits
Due-diligence and for-cause audits of CROs, central labs and specialty vendors — outsource with confidence.
Learn moreMock FDA & EMA Inspection Readiness
A full dress-rehearsal inspection with a prioritized gap list so your team and documents are ready before the agency arrives.
Learn moreTrial Master File (TMF) Audits
Completeness, quality and inspection-readiness checks of paper TMF and eTMF against the DIA TMF Reference Model.
Learn moreCAPA & Root Cause Analysis
Root-cause investigation and CAPA plans that actually close findings and stand up to regulatory scrutiny.
Learn moreHow It Works
A clear, low-friction audit process
- 1
Scope & Plan
Objectives, risk areas and standards defined up front, with a tailored audit plan.
- 2
Conduct the Audit
On-site, remote or hybrid review of documents, systems, data and interviews.
- 3
Report & Findings
A risk-ranked report with evidence and actionable recommendations — in days.
- 4
CAPA & Follow-up
Root-cause support and CAPA verification so findings are genuinely closed.
Ready to make your trial inspection-ready?
Free initial consultation to scope your audit needs — usually a reply within one business day.