FDA EIR - IQVIA - November 08, 2018

A comprehensive FDA inspection of IQVIA, a contract research organization (CRO) located in Durham, NC, took place from November 6-8, 2018. This pre-announced inspection, assigned by the Office of Scientific Investigations/Center for Drug Evaluation and Research (CDER), specifically aimed to verify the integrity of retrospective real-world data collected in support of a supplemental New Drug Application. The regulatory oversight was guided by Compliance Program Guidance Manual CPGM 7348.810, which governs Bioresearch Monitoring for Sponsors and CROs. The inspection included a review of the firm's data collection and analysis procedures, filtering processes, and related contract services for a specific study involving pharmacy claims data. Importantly, this inspection, much like a previous one conducted earlier in 2018, concluded without identifying any significant objectionable conditions or practices. As a result, no FDA Form 483, indicating observations of regulatory deficiencies, was issued to IQVIA. Following discussions with management, the inspection report and collected exhibits were forwarded to CDER for final review and classification. Since no violations were found, no specific corrective or required actions were mandated for the company, signifying compliance with the pertinent regulatory requirements for clinical trial management and data integrity.