Quality in the outsourcing process: part I. The quality outsourcer

AbstractIn clinical research, the definition of quality and overall responsibility for ensuring that performance parameters are adequately tracked and the necessary corrective action taken, lies firmly in the hands of the outsourcing project director/manager (outsourcer or sponsor). Meticulous planning of requirements prior to project start and strong ‘general management’ throughout the life of the outsourced project play a critical role in influencing both the outcome of the study and also in determining the quality of the research data. For ‘quality in the outsourcing process’, read ‘quality outsourcing’. The implementation of a carefully formulated project‐specific outsourcing strategy means that macromanagement (general management), not micromanagement (defined here as a form of ‘intensive therapy for the ailing project’ management), will be the primary task of the sponsor. A research team that is well‐defined, with all members (sponsor and vendor alike) mindful of their individual responsibilities, in addition to being well‐directed, will achieve consensus of opinion faster and deliver a quality product. An outsourcing strategy for the full clinical development program, clearly defined outsourcing standard operating procedures (SOPs) and a strategy tailored to each individually outsourced project form an integral part of the recipe to outsourcing success. Individual components of an outsourcing strategy and how one can safeguard that an outsourced project is brought to completion successfully, and to the prescribed quality standards, are addressed in detail in this article. Part two of this article, entitled ‘Quality in the Outsourcing Process: II. The Vendor Selection Process and The Quality Vendor’, will provide the quality outsourcer with tips and tools on how to make a quality decision in the vendor selection process and addresses further issues that are fundamental to the maintenance of quality in the outsourcing process. Copyright © 2001 John Wiley & Sons, Ltd.