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

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.


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

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.


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

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

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

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

Overview

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.


Product Details

ISBN-13: 9781409457954
Publisher: Ashgate Publishing Ltd
Publication date: 09/28/2012
Sold by: Barnes & Noble
Format: eBook
File size: 3 MB

About the Author

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.


Table of Contents

Contents: 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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