Outsourcing clinical work doesn't outsource the responsibility — sponsors remain accountable for GCP compliance. A qualification audit verifies that a CRO or vendor has the quality systems, staff and controls to run your study to standard, and gives you the documented oversight regulators expect.
I perform pre-award qualification audits, periodic re-qualification, and for-cause audits when performance signals arise.
What the audit covers
- Quality management system and SOPs
- Staff qualification, training and capacity
- Project management and sponsor-oversight processes
- Data management, biostatistics and pharmacovigilance (as applicable)
- Computer systems validation and 21 CFR Part 11
- The CRO's own oversight of its subcontractors and vendors
What you receive
- Qualification audit plan tailored to the scope of work
- Audit report with a clear qualification recommendation
- CAPA tracking and re-qualification guidance
Why it matters
The right vendor decision, backed by a documented audit, prevents quality problems that are far more expensive — and harder to fix — once the study is underway.
Standards & frameworks
Frequently asked questions
What is a CRO qualification audit?
A CRO qualification audit is an independent assessment of a contract research organization's quality systems, staffing, processes and controls to confirm it can deliver the contracted work in compliance with GCP before a sponsor awards or continues the work.
When should I audit a vendor?
Audit before awarding significant work (qualification), on a periodic risk-based cycle (re-qualification), and for-cause when issues such as missed timelines, data problems or quality events arise.