FDA 483 - Clario Inc - March 04, 2022

BioClinica, Inc., a Contract Research Organization in Princeton, NJ, was cited for failing to ensure that an investigation was conducted in accordance with the general investigational plan and protocols specified in an Investigational New Drug (IND) application. Specifically, the firm did not verify tumor assessment timepoints as per the revised assessment schedule for a Phase 2 study on non-small cell lung cancer. This resulted in multiple subjects having out-of-range imaging timepoints, indicating a deviation from the study protocol.