Designing Success into Outsourced Pharmaceutical Projects at the Proposal Stage


A well-written project scope or statement of work is the cornerstone for any outsourced work. An effective scope document is written from the perspective of both the sponsor and the provider. Understanding and defining this mutual perspective requires considerably more effort, discussion, and internal alignment at the sponsor than is often done. The work itself needs to be defined not only in the context of the specific project, but also in the context of the sponsor’s overall project objectives, project management expectations, and commercial philosophy. A project for which these objectives and expectations are clearly stated in a Request for Proposal (RFP) is far more likely to lead to success than a project in which objectives and expectations are not clearly defined. This article outlines those factors that should be considered in developing scope and other aspects of the RFP, and offers suggestions for how this should be accomplished.

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  1. 1.

    PharmSource Information Service. Managing Outsourced Projects. In Special Report, Bio/Pharmaceutical Outsourcing Report. Springfield, VA: PharmSource Information Services; 2000;3.

  2. 2.

    Mucha M. A bulk manufacturer/licensed pharmaceutical perspective on outsourcing. Pharma Tech, Contract Serv. 2000;12–16.

  3. 3.

    Vardzel G. Trust: The secret of success for contract research organizations. Pharma Tech, Contract Serv. 2000;44–46.

  4. 4.

    Bates S, Sloan SE. Outsourcing regulatory activities: How a policy can drive good decisions. Drug Inf J. 2000;34(3):981–985.

  5. 5.

    Medicines Control Agency. Rules and Guidance for Pharmaceutical Manufacturers and Distributors 1997. London, UK: Medicines Control Agency, Department of Health; 1997.

  6. 6.

    Stephon DM. Supplier considerations in quality agreements. J cGMP Compliance. 2000;5(2):19–25.

  7. 7.

    Bobrowicz G. The quality agreement: Compliance considerations in selecting a contract manufacturer. BioPharm. 2001;14(2):14–20.

  8. 8.

    Stempien S. Better contracts for improved outsourcing. Pharma Tech, Contract Serv. 1999; 60–70.

  9. 9.

    Getz K. Strategic sourcing. Appl Clin Trials. 1998; 7(6):40–42.

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Correspondence to Martin H. Joyce MBA, C.P.M..

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Joyce, M.H. Designing Success into Outsourced Pharmaceutical Projects at the Proposal Stage. Ther Innov Regul Sci 36, 67–76 (2002).

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  • Outsourcing
  • Request for proposal
  • Project management
  • Scope
  • Metrics