Clario Inc – FDA EIR, Jan 10, 2022

An FDA inspection of BioClinica, Inc. in Princeton, NJ, was conducted from February 28 to March 4, 2022. This routine surveillance, requested by the Center for Drug Evaluation and Research (CDER) under the Sponsors and Contract Research Organizations Compliance Program (CP) 7348.810, focused on the firm's role in a clinical study involving independent central review of radiographic images. The inspection resulted in one observation on Form FDA 483, citing BioClinica's failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols, as specified in the Investigational New Drug (IND). This points to deficiencies in addressing study-related issues or deviations. Additionally, discussion items included outdated training materials that did not reflect current charter versions and project-specific work instructions that failed to incorporate protocol amendments regarding assessment schedules. The inspection also noted numerous efficacy timepoints evaluated outside of the protocol's defined schedule. BioClinica's management acknowledged these findings at the closeout meeting, stating a commitment to investigate the issues and submit a written response to the Agency addressing the required actions. The prior inspection in January 2022 had no observations.