FDA EIR - PAREXEL INTERNATIONAL, Corp - July 15, 2019

An FDA Bioresearch Monitoring (BIMO) inspection was conducted at Parexel's Billerica, MA facility between July 11 and July 15, 2019. This high-priority review, initiated under Compliance Program 7348.810, assessed Parexel's operations as a Contract Research Organization (CRO) supporting Tesaro, Inc.'s clinical study protocol PR-30-5020-C (QUADRA). The study focused on the safety and efficacy of niraparib for ovarian cancer, and the inspection formed part of a Supplemental New Drug Application (sNDA) process, emphasizing data integrity and Good Clinical Practice. The scope of the review included Parexel's policies, study registration, quality assurance processes, endpoint data verification, record retention, and electronic record management systems.

The inspection concluded without the issuance of a Form FDA-483 or any formal regulatory violations, indicating a generally compliant state. No samples were collected, and the firm cooperated fully. One discussion item was brought to management's attention regarding discrepancies in the effective dates and signature dates for the Master Service Agreement (MSA) and Statement of Work (SOW) governing Parexel's services. The effective dates for these documents predated their actual signature dates. Parexel was cautioned that commencing study-related work prior to formalized contractual signatures could potentially result in future FDA Inspectional Observations. This serves as a professional advisory emphasizing the need for meticulous adherence to documentation timelines within the regulatory framework.