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Main Title Contract Research and Development Organizations Their Role in Global Product Development / [electronic resource] :
Author Gad, Shayne C.
Other Authors
Author Title of a Work
Spainhour, Charles B.
Publisher Springer New York : Imprint: Springer,
Year Published 2011
Call Number RM1-950
ISBN 9781461400493
Subjects Medicine ; Toxicology ; Biotechnology ; Biochemistry ; Pharmacy
Internet Access
Description Access URL
Collation XII, 212 p. online resource.
Due to license restrictions, this resource is available to EPA employees and authorized contractors only
Contents Notes
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. 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 outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. Contract Research and Development Organizations: Their Role in Global Product Development has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants. Included in the volume are an exhaustive listing of those CROs in the (drug and device) safety evaluation sector and their contact information and capabilities, and extensive similar listing for the other types of contract service providers. Also included are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP facilities. These listings are international in scope, and a specific chapter addresses working with some of the newer international CROs.