The Selection and Use of Contract Research Organizations: 1st Edition (Hardback) book cover

The Selection and Use of Contract Research Organizations

1st Edition

By Shayne C. Gad

CRC Press

188 pages

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Hardback: 9780415299039
pub: 2003-07-03
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Description

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.

  • Reviews

    "[This book] is recommended for medical practices and libraries, and academic libraries with relevant programs of study or research areas."

    - E-Streams, Vol. 7, No. 5, May 2004

    Table of Contents

    Introduction

    The Pharmaceutical Development Process

    The Medical Device Development Process

    Functions and Types of CRO's

    Selection of CRO

    Pricing and Cost

    Monitoring Work

    Common Problems and their Solutions

    Appendix

    Labs List

    Miscellaneous Labs and Services

    Analytical Labs

    GMP Contract Facilities

    Formulation

    Dosage From

    Clinical Testing

    Regulatory Services

    Audit Checklist

    Subject Categories

    BISAC Subject Codes/Headings:
    COM032000
    COMPUTERS / Information Technology
    MED000000
    MEDICAL / General
    MED002000
    MEDICAL / Administration
    MED071000
    MEDICAL / Pharmacology
    MED096000
    MEDICAL / Toxicology