FDA EIR - IQVIA - January 30, 2019

IQVIA, a contract research organization in Durham, NC, underwent an FDA inspection from January 28-30, 2019. This Premarket Original New Drug Application (NDA) inspection, conducted under Compliance Program 7348.810, focused on IQVIA's contracted monitoring activities for three clinical research protocols sponsored by another entity. The primary observation was that IQVIA did not maintain any records or documentation related to these specific studies at its facility. All relevant electronic Trial Master Files (eTMFs) were held by the sponsor, and IQVIA staff did not have access to them for review during the inspection. Under its Functional Service Provider model, IQVIA staff essentially operated as an extension of the sponsor's team, following their procedures and reporting work product directly. Consequently, FDA investigators were unable to verify certain activities, as the records were not present at IQVIA. Importantly, no objectionable conditions were identified during the inspection, and therefore, no FDA Form 483 was issued, indicating no formal violations or mandated corrective actions for IQVIA.