A sponsor audit is your quality function looking hard at how a trial is really being run. As an independent GCP auditor, I give pharmaceutical sponsors, biotechs and device companies an objective, regulator's-eye view of their processes, vendors and study conduct — covering the gaps internal teams are often too close to see.
Whether you need a routine internal system audit, a for-cause audit triggered by a signal, or focused oversight of a specific study, every engagement is risk-based and mapped to ICH E6(R2)/E6(R3) and your own SOPs.
What the audit covers
- Quality management system, SOPs and training records
- Protocol compliance and study oversight
- Sponsor oversight of CROs and vendors
- Safety reporting and pharmacovigilance interfaces
- Data management, monitoring and TMF processes
- Computer systems and 21 CFR Part 11 controls
What you receive
- Risk-based audit plan and agenda, agreed up front
- Clear, risk-ranked audit report backed by objective evidence
- Practical, prioritized recommendations
- CAPA support and follow-up verification
Why it matters
Regulators expect sponsors to maintain oversight and to know where their own risks are. A well-run internal audit program demonstrates that control — and turns findings into fixes long before an inspection.
Standards & frameworks
Frequently asked questions
What is a sponsor audit in clinical research?
A sponsor audit is a planned, independent quality check arranged by the trial sponsor to verify that a study, process or vendor complies with Good Clinical Practice and the protocol — identifying and correcting issues before a regulatory inspection.
How often should sponsors run internal GCP audits?
It depends on risk. Most sponsors maintain a risk-based audit schedule covering high-risk studies, vendors and systems annually, with for-cause audits triggered by signals such as data trends, complaints or staff turnover.