While inspections of studies with pending marketing applications are considered routine, FDA has recently shifted its focus toward an early intervention paradigm. Under this design, BIMO Inspections can occur prior to trial completion. This approach allows FDA the opportunity to affect proactive change and continuously improve clinical investigator compliance. Early intervention inspections can be challenging to predict as the audits are not necessarily triggered by a sponsor regulatory submission.
To ensure you are fully prepared for your next FDA inspection, we’ve put together this helpful resource, Elements of a Regulatory Inspection: What You Need to Know.
Our latest whitepaper covers several approaches that can help you prepare for an inspection, including:
- Review of recent inspection findings
- Evaluation of your site through the BIMO Compliance Program Guidance Manual (CPGM)
- Ensuring familiarity with IRB and institutional policies
- Audit planning and mock inspections
Understanding how to use these resources to assure compliance will greatly improve inspection readiness. Inspection preparation should start on the first day of the trial, and, if done, will ensure all is ready if and when the FDA calls.
Please take time to download IMARC’s new whitepaper “Elements of Regulatory Inspection: What You Need to Know” and share your thoughts with us.