Vendor Selection & Management

Abstract

Vendors provide services that are critical to the successful outcome of a clinical study, yet sponsors retain the ultimate responsibility for activities that are outsourced. Thus, if a sponsor delegates study activities to a vendor or a vendor’s vendor and so on, the sponsor should take measures to ensure the vendor and any subcontractors are consistently delivering products or services of acceptable quality. This chapter provides recommendations for evaluating, selecting, and providing oversight of vendors to determine whether their services adequately meet sponsor expectations including quality requirements and regulatory standards.