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

Between February 24 and February 27, 2025, the FDA inspected the facility of Bioclinica Inc. / Clario (operating as eResearch Technology, Inc.) in Shanghai, China. As a Contract Research Organization (CRO), the firm was cited for failing to fulfill transferred clinical study obligations, specifically regarding computer system validation and data integrity protocols. The inspection revealed that the firm utilized unvalidated software applications to analyze bone mineral density data for clinical investigations. Because these systems lacked proper validation, they failed to maintain audit trails, meaning the firm could not track edits, deletions, or the identity of users modifying critical data. This created significant risks regarding the reliability of the clinical records. Furthermore, the firm did not follow established procedures to ensure data accuracy. Specific errors included the incorrect application of data correction factors for 31 subjects and the improper exclusion of required subject data from final transfer files. These observations were made under the authority of the Federal Food, Drug, and Cosmetic Act. While the FDA 483 form does not represent a final determination of compliance, the firm is required to respond to these observations. Bioclinica Inc. must outline corrective and preventive actions to address the software validation gaps and ensure that all clinical trial data is processed, managed, and reported with complete accuracy and accountability.