FDA 483 - eResearch Technology Inc. (dba Clario) - February 27, 2025

An FDA inspection of Bioclinica Inc. / Clario in Shanghai, China, a Contract Research Organization, revealed significant deficiencies in computer system validation and data integrity practices. The firm failed to validate software used for clinical investigation data, leading to critical data integrity gaps and an inability to ensure the accuracy and reliability of clinical trial data. These issues included missing audit trails, unauthorized modifications, and improper data transfers affecting multiple subjects.