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

Gad, Shayne C.

 
9780415299039: The Selection and Use of Contract Research Organizations: A Guide for the Pharmaceutical and Medical Device Industries
Hardcover
ISBN 10: 0415299039 ISBN 13: 9780415299039
Verlag: CRC Press, 2003

Inhaltsangabe

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.

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    Über die Autorin bzw. den Autor

    Shayne C. Gad

    Von der hinteren Coverseite

    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.

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    Verlag
    CRC Press
    Erscheinungsdatum
    2003
    Sprache
    Englisch
    ISBN 10 
    0415299039
    ISBN 13 
    9780415299039
    Einband
    Gebundene Ausgabe
    Auflage
    1
    Anzahl der Seiten
    208
    Kontakt zum Hersteller
    Nicht verfügbar
    Verantwortliche Person
    Nicht verfügbar