FDA EIR - BioClinica Inc. - September 26, 2019

An FDA inspection of BioClinica Inc., a Contracted Research Organization in Princeton, NJ, was conducted from September 24-26, 2019. This high-priority inspection, requested by the Office of Scientific Investigations, focused on adherence to regulatory guidelines for sponsors, contract research organizations, and monitors (CP7348.810). The review specifically covered a clinical study involving data verification from three clinical sites, assessing processes for image acquisition, independent reader reviews, accurate documentation for safety and efficacy endpoints, and data transfer to the sponsor. While no formal FDA Form 483 Inspectional Observations were issued, the inspection identified one critical data discrepancy. A subject's identifier was incorrectly recorded in specific data sets. Although corrections were initiated, one particular entry (Cycle 19, Radiology 2) remained uncorrected. Management acknowledged this finding and committed to rectifying the error and implementing measures to prevent future data inaccuracies before submitting data to the study sponsor. The FDA investigator emphasized the importance of thorough data verification prior to submission. This inspection ensures data integrity for drug development studies.