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Assessing the Benefits and Risks of Internal Manufacturing vs. Outsourcing Production of Biological Clinical Material

By: Rodney E. Thompson, Ph.D. and Howard L. Levine, Ph.D
Reprinted with permission of American Pharmaceutical Outsourcing Vol. 3, 7-15, 2002

Successful outsourcing requires analysis of and attention to numerous components of a complex interaction between the Sponsor and the Contractor. Both organizations must understand the basis of the interaction and its limits as defined in written and verbal communications, listen closely to the needs of the other organization, and treat each other with honesty and mutual respect. Open and frequent communication is essential for success; this communication falls primarily in four areas: business terms, project management, technology transfer and compliance. Strong lines of communication in each of these areas will ensure rapid exchange of information, problem solving and effective conflict resolution. Methods for ensuring optimal interaction and communication between the client and the contractor, ways to avoid typical outsourcing problems and the best techniques to achieve successful outsourcing are presented.