The selection and use of contract research organizations : a guide for the pharmaceutical and medical device industries
Author(s)
Bibliographic Information
The selection and use of contract research organizations : a guide for the pharmaceutical and medical device industries
Taylor & Francis, 2003
Available at 3 libraries
  Aomori
  Iwate
  Miyagi
  Akita
  Yamagata
  Fukushima
  Ibaraki
  Tochigi
  Gunma
  Saitama
  Chiba
  Tokyo
  Kanagawa
  Niigata
  Toyama
  Ishikawa
  Fukui
  Yamanashi
  Nagano
  Gifu
  Shizuoka
  Aichi
  Mie
  Shiga
  Kyoto
  Osaka
  Hyogo
  Nara
  Wakayama
  Tottori
  Shimane
  Okayama
  Hiroshima
  Yamaguchi
  Tokushima
  Kagawa
  Ehime
  Kochi
  Fukuoka
  Saga
  Nagasaki
  Kumamoto
  Oita
  Miyazaki
  Kagoshima
  Okinawa
  Korea
  China
  Thailand
  United Kingdom
  Germany
  Switzerland
  France
  Belgium
  Netherlands
  Sweden
  Norway
  United States of America
Note
Includes bibliographical references and index
Description and Table of Contents
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.
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.
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