The Selection and Use of Contract Research Organizations: A Guide for the Pharmaceutical and Medical Device Industries - Hardcover

Gad, Shayne C.

Hardcover

ISBN 10: 0415299039 ISBN 13: 9780415299039

Publisher: CRC Press, 2003

Synopsis

Choosing the right contract research organization (CRO) can make the difference between getting a product to market quickly and cost-effectively, and wasting valuable time and money. The vast number of available CROs is increasing all the time, and all of them make impressive claims. The Selection and Use of Contract Research Organizations is your essential guide to choosing the best provider.

A history of the CRO industry, audit checklists, and overviews of both the pharmaceutical and medical device development processes create a comprehensive overview of how to successfully select and manage a CRO for your project. The book also discusses:

Guidance for selection, protocol and contract development, project management and monitoring of work

Common pitfalls and problems - how to avoid them, and how to solve them if they do occur

How to integrate efforts between groups to achieve the greatest cost effectiveness while maintaining quality and timely production

Prototype forms and templates for increasing coordination between multiple working groups

A series of appendices covering hundreds of prominent service providers worldwide, including contact information

Operative regulations and laws

In addition to providing fundamental guidance on how to select and manage a CRO in the product development process, this reference also includes a set of eight databases that contain contact information for prominent service providers in North America, Europe, and Japan, and overviews of services they offer. It is a complete resource for professionals in biotechnology, and pharmaceutical and medical device development.

About this title

About the Author

Shayne C. Gad

From the Back Cover

Choosing the right contract research organization (CRO) can make the difference between getting a drug or medical device to market quickly and cost-effectively and wasting valuable time and money. This book provides guidelines for selection, protocol, and contract development; discusses project management and monitoring of work; explores how to integrate efforts between groups to achieve the greatest cost effectiveness while maintaining quality and not losing time; and includes prototype forms and templates for use in the above processes. It covers common pitfalls, how to avoid them, and how to solve them if they do occur. The appendices contain contact information for hundreds of prominent service providers.

Edition details

• Publisher: CRC Press
• Publication date: 2003
• Language: English
• ISBN 10: 0415299039
• ISBN 13: 9780415299039
• Binding: Hardcover
• Edition number: 1
• Number of pages: 188