FDA EIR - Imaging Endpoints II, LLC. - June 07, 2018

An FDA surveillance inspection of Imaging Endpoints, a contract research organization in Scottsdale, AZ, was conducted from June 4-7, 2018. This routine inspection, assigned by the Center for Drug Evaluation and Research (CDER) under the Bioresearch Monitoring Compliance Program, focused on data integrity for a prescription drug new drug application (NDA) and adherence to Good Clinical Practices (GCPs). The inspection involved a detailed review of the trial master file and subject records for Protocol # (b) (4), a study involving 47 active subjects and 576 images. During the inspection, the firm's operations, personnel training, data collection and handling procedures, record retention, financial disclosure, and electronic records systems were examined. Key personnel, including Mr. Manuel T. Ramirez, Senior Vice President, Compliance and Regulatory Affairs, facilitated the inspection. Notably, the inspection concluded without any adverse findings. No FDA Form 483, Inspectional Observations, was issued, indicating that no deficiencies were identified. Consequently, no mandatory corrective actions were required from Imaging Endpoints. This outcome signifies the firm's compliance with applicable regulatory standards during the inspection period.