Outsourcing Clinical Development: Strategies for Working with Cros and Other Partners

ISBN-13: 9780566086861 / Angielski / Twarda / 2006 / 192 str.

Baguley, Jane

Opis

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.

Recenzje

'This book will become a standard reference text for anyone involved in managing outsourced contracts (from either the customer or supplier perspective), a challenge to senior managers who have yet to take the plunge beyond outsourcing as a tactical solution to a specific study, and a useful manual for the rest of us who are likely to become increasingly involved with outsourced clinical development in the coming years.' Clinical Research Focus

Spis treści

Chapter 1 Outsourcing Strategies, JeffThomis, SmitaDesai; Chapter 2 Selection of Candidates, RikkeWinther,, H.Lundbeck A/S; Chapter 3 Request for Proposal, EmmaSabin; Chapter 4 Risk Management, NermeenVarawalla; Chapter 5 Negotiation, JimCannon; Chapter 6 Contract Types, AlanMorgan; Chapter 7 The Contract, PaulRanson; Chapter 8 Strategic Relationship Management, NadiaTurner,, AstraZeneca; Chapter 9 Performance Management, MichelleCuddigan, SarahKing; Chapter 101 Summary, CarlEmerson,, Jean S.Edwards; Chapter 102 The PCMG;

O autorze

Jane E. Winter is an experienced general manager with 24 years spent in pharma and CROs. Jane has set up and developed a contract research company, managed the UK arm of a major CRO, held various European roles responsible for quality assurance, training, acquisitions and strategic alliances. Jane now runs a successful consultancy company advising the industry in the area of outsourcing. Jane Baguley has 18 years' experience within both pharma and CRO. She has held various operational and business management roles including project management, medical writing, business development, internal communication, business management, acquisitions and strategy.