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

Bioclinica Inc. / Clario, a Contract Research Organization in Shanghai, China, was cited for significant deficiencies related to computer system validation and data integrity during clinical investigations. The firm failed to validate software used for clinical study data analysis, leading to critical data integrity gaps such as lack of audit trails and unauthorized modifications. Additionally, the firm did not establish or follow adequate procedures to ensure the accuracy and reliability of clinical trial data, resulting in errors during data transfers.