FDA EIR - BioTel Research, LLC - October 03, 2019

An FDA inspection of BioTelemetry Research in Rochester, NY, was conducted from October 1 to October 3, 2019. This high-priority data integrity inspection, requested by the Center for Drug Evaluation and Research, focused on the company's operations as an imaging Contract Research Organization (CRO). The inspection adhered to guidance from Compliance Program 7348.810 and evaluated BioTelemetry's fulfillment of sponsor obligations under 21 CFR 312.52 and ICH Guidance Topic E6: Good Clinical Practice 5.2. The primary objective was to verify the integrity of blinded, independent imaging reviews for disease response and progression in a specific clinical study supporting a New Drug Application.

The inspection encompassed a thorough review of standard operating procedures, selection and monitoring of independent image readers, quality assurance processes, and the management of study data. Investigators reviewed imaging case sets and corresponding records for 60 subjects. The assessment concluded that BioTelemetry's procedures and analyses for blinded imaging were consistent with the Imaging Review Charter, protocol, and applicable FDA regulations. No violations or objectionable conditions were identified during the inspection, and therefore, a Form FDA 483 (Inspectional Observations) was not issued. As a result, no required actions were necessitated, and the inspection concluded without any findings requiring further discussion, indicating full compliance.