The Selection and Use of Contract Research Organizations (Google eBook)

Front Cover
CRC Press, Jun 2, 2004 - Medical - 188 pages
0 Reviews
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.
  •   

    What people are saying - Write a review

    We haven't found any reviews in the usual places.

    Contents

    CHAPTER 1 Introduction
    1
    CHAPTER 2 The Pharmaceutical Development Process
    31
    CHAPTER 3 The Medical Device Development Process
    45
    CHAPTER 4 Functions and Types of CROs
    61
    CHAPTER 5 Selection of CROs
    71
    CHAPTER 6 ContractingPricing and Cost of Works Performed by CROs
    93
    CHAPTER 7 Monitoring Ongoing Studies and Work
    107
    CHAPTER 8 Common Problems and their Solutions
    113
    APPENDIX C Analytical Labs
    135
    APPENDIX D GMP Contract Facilities
    141
    APPENDIX E Formulation
    147
    APPENDIX F Dosage Forms
    151
    APPENDIX G Clinical Testing
    155
    APPENDIX H Regulatory Services
    165
    APPENDIX I Contract Laboratory Audit Check List
    171
    Index
    177

    APPENDIX A Toxicology Labs
    121
    APPENDIX B Miscellaneous Labs and Services
    129

    Common terms and phrases

    Bibliographic information