ABSTRACT
This chapter presents the alternative methodologies currently being used by pharmaceutical sponsors to contract with vendors, analyse the advantages and disadvantages of the different approaches, and attempt to provide a practical framework which the reader can then adapt for his or her specific needs. Any type of contract is either explicitly or implicitly linked to an outsourcing philosophy within a company. Understanding what that philosophy represents is an important part of ensuring that the contract meets the needs of both parties and there is goal congruence. The chapter focuses on reviewing the alternative philosophies of contracting methodologies for the overall contract research organization (CRO) fee. The basis of costing for these types of contracts is based on per product, equipment or test cost. This is probably the type of outsourcing best suited to online auction techniques to determine the most competitive price. Fee-for-service contracting was the traditional model used in the infancy of outsourcing clinical services to vendors.
