Case Study | FDA Inspection Readiness | Site Level Success

FDA Inspection Readiness

Site Level Success

Issue

CRA-reported finding triggered an IRB audit of the site. The IRB audit findings ultimately led to a FDA site inspection.

Sponsor

US-based clinical stage, biopharmaceutical company

Project

Phase II, multicenter, metastatic renal cell carcinoma (RCC) trial

Challenge

Site failed to perform required lab assessments for 3 patients
Discovered and reported to the IRB by ProTrials monitoring CRA
One week to prepare site for unanticipated FDA inspection

Solutions

CRA provided additional site training regarding required lab assessments
ProTrials QA team directed study team to identify areas to focus on, such as:
- % SDV, monitoring plan compliance, and site communication documentation
- Review eTMF site currency
- Issue escalation follow up

Results

No 483 issued to ProTrials (CRO)
One 483 issued to site for lack of protocol compliance
No additional site protocol compliance issues following the FDA inspection