Large Company Use of Contract Research Organizations—The Implications for Quality Assurance

Abstract

Pfizer uses contract research organizations (CRO) to help with occasional peaks in the workload. This paper details the use of CROs to handle an entire clinical trial and hiring contract clinical quality assurance auditors to audit sponsor-managed clinical trials—from the viewpoint of the sponsor. For a successful relationship, both sponsor and CRO must be committed to clinical quality assurance.