Sponsor companies and CROs alike will appreciate the industry-wide analysis, practical, how-to advice, and helpful charts and checklists provided by Outsourcing in Clinical Drug Development. A panel of experts discuss supplier identification and selection, financial considerations, and the ethical issues. They cover contracting out laboratory analysis, data management, and statistical services, and the effects of outsourcing on quality assurance. Whether readers are beginning to explore the possibility of outsourcing or already involved in long-term strategic outsourcing partnerships, this invaluable resource is a complete guide to the drug development outsourcing relationship.
Author(s): Roy Drucker, Graham Hughes
Edition: 1
Year: 2002
Language: English
Pages: 268
Front Cover......Page 1
Contents......Page 6
Preface......Page 12
1. Suppliers to Healthcare R&D......Page 14
2. The Sourcing Decision......Page 34
3. Supplier Identification, Evaluation, and Selection......Page 48
4. Financial and Organizational Outsourcing Considerations......Page 64
5. Clinical Research Contracting—A Legal Perspective......Page 72
6. Ethical Considerations in Outsourced Clinical Trials......Page 86
7. Avoiding and Managing Conflict in Outsourcing Clinical Research......Page 100
8. The Role of Site Management Organizations......Page 112
9. Clinical Trial Supplies—The Vital Link......Page 134
10. Contracting Out Laboratory Analysis......Page 150
11. Contracting Data Management and Statistical Services......Page 164
12. Global Clinical Trials: The Cultural Challenge......Page 182
13. Outsourcing and the Use of Contract Quality Assurance......Page 198
14. Contracting Out Regulatory Projects to a Regulatory CRO......Page 210
15. Trends in Pharmaceutical Development Outsourcing......Page 226
Appendix......Page 248
Contributors......Page 254
Index......Page 262
