1st Edition

The Selection and Use of Contract Research Organizations

By Shayne C. Gad Copyright 2003

    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.
  • 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

    Labs List
    Miscellaneous Labs and Services
    Analytical Labs
    GMP Contract Facilities
    Dosage From
    Clinical Testing
    Regulatory Services
    Audit Checklist


    Shayne C. Gad

    "[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