Regulatory inspections of clinical trials are designed to test whether subject protection and data integrity are real, not just written into SOPs. Sponsors and sites often underestimate how rigorous and unpredictable these visits can be. Even organizations with compliant intent can stumble when inspectors ask for specific documents, drill into data listings, or interview staff about what actually happens day to day. Without a structured approach to auditing and mock inspections, gaps in documentation, vendor oversight, or GCP execution may only surface when FDA or other authorities are already on site.
HIC conducts clinical audits and mock inspections that mirror how regulators think and work. Our audit teams, which include former FDA investigators and experienced quality leaders, review protocols, case histories, vendor management, and data flows across the trial lifecycle. We test staff readiness through interviews, conduct system walkthroughs to assess inspection logistics, and evaluate how issues and findings are documented and escalated. Findings are prioritized by regulatory risk, and we work with your team to design practical corrective and preventive actions, so issues are resolved before regulators arrive. The result is a sponsor or site that enters inspections prepared, confident, and far less likely to receive significant observations.
Audits that expose what regulators will question
- Our audits are led by former FDA investigators who replicate real inspection methods, questioning, and document flows
- We evaluate study conduct, data integrity, and vendor oversight from start-up through closeout, so issues are caught early, not at database lock
- We coach staff on how to respond during interviews, manage document requests, and handle inspection day logistics without losing control of the narrative
- We deliver prioritized findings and help design and implement corrective actions, so inspection readiness is demonstrable before regulators arrive
