Contract Research and Development Organizations Their Role in Global Product Development /

• Main Authors: Gad, Shayne C. (Author), Spainhour, Charles B. (Author)
• Corporate Author: SpringerLink (Online service)
• Format: Electronic eBook
• Language: English
• Published: New York, NY : Springer New York : Imprint: Springer, 2011.
• Subjects: Medicine.; Pharmacy.; Pharmacology.; Biotechnology.; Medicinal chemistry.; Biomedicine.; Pharmacology/Toxicology.; Medicinal Chemistry.

The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been...

Table of Contents:

• Introduction
• The pharmaceutical Development Process & Testing Requirements
• The Medical Device Development Process & Testing Requirements
• Functions and Types of CROs (referencing function listings in appendices)
• Selection of CROs
• Labs in China and India
• Contracting, Pricing, and Cost of Works Performed by CROs
• Monitoring Ongoing Studies and Work
• Common Problems and their Solutions
• Appendix.