FDA EIR - PAREXEL INTERNATIONAL, Corp - August 05, 2020

This FDA Bioresearch Monitoring (BIMO) inspection of Parexel International, a Contract Research Organization (CRO) in Billerica, MA, was conducted from August 3-5, 2020. The inspection, carried out under BIMO Compliance Program Guidance Manual 7348.810, focused on Parexel's independent radiology review responsibilities for a specific clinical trial. The primary issue identified was a critical lapse in the timely collection and inclusion of certain clinical data reports in Parexel's radiology reviews between November 2018 and December 2019. This was due to miscommunication where a third-party study site management contractor incorrectly advised Parexel that these reports were not needed. This oversight resulted in at least three study subjects having their Overall Response determinations changed retrospectively based on late-received reports, which were not reflected in the sponsor's data listings by the January 1, 2020, data cutoff. Other minor data discrepancies were also noted. Despite these findings, the FDA did not issue a Form FDA 483 (Inspectional Observations). Parexel management acknowledged the issue and stated that process improvements were already implemented. These include enhanced communication protocols with other CROs and sponsors, and the development of a tracker system to ensure timely collection of all necessary reports. The inspection concluded with a discussion of these corrective actions, with the report forwarded for classification.