FDA EIR - BioClinica, Inc. - May 12, 2022

An FDA surveillance inspection of BioClinica, Inc., a Contract Research Organization (CRO) in Princeton, NJ, took place from May 6 to May 12, 2022. The inspection, requested by the Center for Drug Evaluation and Research (CDER), aimed to assess compliance with the Sponsor, Contract Research Organizations and Monitor Compliance Program (CPGM) 7348.810. BioClinica specializes in providing independent radiology imaging review for clinical trials. The scope of the inspection included a review of contract agreements, written procedures, communication plans, reader training, and data verification processes for specific study protocols. Importantly, the FDA inspector did not issue any Form FDA-483 Inspectional Observations or present any discussion items, indicating full compliance during this inspection period.

The report referenced findings from a previous FDA inspection (February-March 2022), which noted BioClinica's failure to verify tumor assessment timepoints according to revised schedules and a need to update training slides for their Independent Review Charter. In response to these prior issues, BioClinica implemented voluntary corrective actions. These included updating a Project Specific Work Instruction (PSWI) to incorporate the latest assessment windowing conventions and completing staff training on these updates by March 25, 2022. The company assessed the prior observation as a minor risk, confirming no adverse impact on study data acquisition, submission, verification, analysis, or transferred results. Furthermore, the current inspection confirmed BioClinica’s electronic systems, SMART Submit and Study Direct, were compliant with 21 CFR Part 11 regulations, featuring comprehensive audit trails.