CRSO QA provides support for non-FDA audits conducted by study sponsors, IRBs, and other regulatory agencies such as the European Medicines Agency (EMA). Services provided may include:
Pre-review of study materials prior to the audit (if prior notification is given)
Educating investigators and study teams on proper audit conduct (including how to interact with the inspector)
Attending opening and daily closing meetings with the auditor and study team
Providing guidance throughout the audit
Assisting with audit findings and writing responses
