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.
Table of Contents
Suppliers to Healthcare R&D. The Sourcing Decision. Supplier Identification, Evaluation. Financial & Organizational Considerations of Outsourcing. Clinical Research Contracting-A Legal Perspective. Ethical Considerations in Outsourced Clinical Trials. Avoiding & Managing Conflict in Outsourcing Relationships. The Site Management Organization. Clinical Trial Supplies. Contracting Out Laboratory Analysis. Contracting Data Management & Statistical Services CROs. Global Clinical Trials: The Cultural Challenge. Contracting Out to a Regulatory CRO. Outsourcing & the Use of Contract Quality Assurance. Trends in Pharmaceutical Development Outsourcing.
Roy Drucker, Graham Hughes