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

The FDA conducted a routine surveillance inspection of Imaging Endpoints, a contract research organization (CRO) in Scottsdale, AZ, from June 4-7, 2018. The inspection was assigned by the Center for Drug Evaluation and Research (CDER) under the Bioresearch Monitoring Compliance Program, specifically focusing on Good Clinical Practices (GCPs) and data integrity as part of a Prescription Drug User-Fee Act (PDUFA) assessment for a drug application. Imaging Endpoints functions as a core lab, providing imaging reading and data management services for clinical trials. The inspection covered a comprehensive review of the firm's trial master file, subject records, training programs, data handling, record retention, financial disclosures, and electronic systems for a specific study. A key outcome of the inspection was that no FDA Form 483, "Inspectional Observations," was issued, indicating that the FDA found no significant violations or issues. Consequently, no regulatory actions were required from Imaging Endpoints, and no voluntary corrections were deemed necessary or applicable, signifying a satisfactory inspection result.