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Outsourcing Clinical Development

Strategies for Working with CROs and Other Partners

Publication Date February 2006
Publisher Ashgate Publishing
Product Type Book
Pages 192
ISBN Number 9780566086861
Product Code ASH00097
Outsourcing Clinical Development
Buy this product or for assistance call +44 20 7060 7474

Summary

The challenges facing large pharmaceutical companies are stark: sales are slowing, and research and development costs are rising. There is an overwhelming need to reduce development costs by as much as 30-40%, while at the same time significantly shortening development cycle times.

Pharmaceutical spend on outsourcing faces double-digit growth for the next three to five years and yet, if outsourcing is to meet these challenges, new models of collaborative and cooperative working are needed now.

Outsourcing Clinical Development offers a guide to these new models and to future clinical outsourcing strategy. There is advice on the basis for an outsourcing strategy and guidance on how to work most productively with CROs (contract research organisations); geographical issues, including working in low-cost environments, are also covered. There is a detailed guide to selecting candidates, and managing the proposal, negotiation and contract process successfully; as well as reviewing outsourcing performance and developing fruitful long-term strategic relationships.

The pharmaceutical outsourcing process is as complex and as influential as the clinical trials it supports. Outsourcing Clinical Development, with a powerful mix of perceptive insight from leading lights in the industry, advice on long-term strategic direction and tools for immediate help is a must-have read for pharmaceutical companies and their CRO partners.

Content

  • Foreword, John C
  • Easton, AstraZeneca
  • Outsourcing strategies, Jeff Thomis and Smita Desai, Quintiles Ltd
  • Selection of candidates, Rikke Winther, H
  • Lundbeck A/S
  • Request for proposal, Emma Sabin, Pfizer Ltd
  • Risk management, Nermeen Varawalla, PRA International, UK
  • Negotiation, Jim Cannon, Cannon Associates
  • Contract types, Alan Morgan, MDS Pharma Services
  • The contract, Paul Ranson, Springer Saul LLP
  • Strategic relationship management, Nadia Turner, AstraZeneca
  • Performance management, Michelle Cuddigan and Sarah King, IBM Business Consulting Services
  • Summary, Carl Emerson, GSK Biologicals and Jean S
  • Edwards, Eli Lilly UK, Pharmaceutical Contract Management Group (PCMG)
  • The PCMG
  • Index.
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