Download or read book Contract Research and Development Organizations written by Shayne C. Gad and published by Springer Science & Business Media. This book was released on 2011-08-04 with total page 213 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book A Report on Research and Development Contracting and Assistance written by and published by . This book was released on 1993 with total page 100 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Research Development Contracting written by and published by . This book was released on 1963 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Research and Development Contracting with the Federal Government written by John E. Miller and published by . This book was released on 1980 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Research and Development Contracting written by 1962 Conference on United States Government Research, Development Contracts, George Washington University and published by . This book was released on with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Air Force Research and Development Contracting Officers Handbook written by United States. Air Force. Systems Command and published by . This book was released on 1967 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Research and Development Contracts written by and published by . This book was released on with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Contract Policies and Procedures for Research and Development written by United States. Congress. House. Select Committee on Government Research and published by . This book was released on 1964 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Small Business Innovation Research Program written by and published by . This book was released on 1989 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Report on Grants and Research Contracts written by United States. Interdepartmental Committee on Scientific Research and Development and published by . This book was released on 1950 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Research Contracts in the Life Sciences written by United States. Energy Research and Development Administration. Division of Biomedical and Environmental Research and published by . This book was released on 1975 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Research and Development Contracting at DOD Laboratories written by and published by . This book was released on 1991 with total page 22 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Research Development Contracting written by Federal Publications Inc and published by . This book was released on 1978 with total page 866 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Research and Development Contracting written by NAVSEC (Organization : U.S.) and published by . This book was released on 1969 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Research and Development Contractors written by Oklahoma State University. Research Foundation and published by . This book was released on 1960 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Public Procurement for Innovation written by Dolores Kuchina-Musina and published by Taylor & Francis. This book was released on 2024-02-16 with total page 83 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this book, nationally recognized public procurement experts Dolores Kuchina-Musina and Benjamin McMartin present a comprehensive analysis of the alternative contract vehicles used to promote innovation in the United States (US). Kuchina-Musina and McMartin begin by introducing the innovation policy environment in the US, addressing current trends in the workforce, decreased investment in research and development (R&D), and how technology is increasing at a rapid speed. They then go on to discuss key terms and subjects to show how public procurement and innovation policy are tied together. Diving deeper, Kuchina-Musina and McMartin examine the pathways the federal government uses such as the Federal Acquisition Regulations (FAR) part 12 acquisition, a review of the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, and non-FAR-based contract overview with a specific focus on Other Transaction Authorities (OTA). Using the new Department of Defense (DoD) prototype OTA that was enacted in November 2015, Kuchina-Musina and McMartin conclude by presenting a methodology for examining the effectiveness of OTs. Specifically, they show the way the government is evaluating the DoD statute and discussions on some of the additional guidance the DoD uses to implement this authority. Bringing academic literature on innovation policy and applying it to the practitioner environment, Public Procurement for Innovation provide its audience an understanding of models, methods, and techniques the US uses to promote the development of innovative technologies and products. Clearly written and impeccably researched, the book fills a huge void in the literature on public procurement.

Download or read book Guide to Special Considerations in Government Research and Development Contracting written by Oscar V. Rodriguez-Morales (CAPT, USAF.) and published by . This book was released on 1989 with total page 214 pages. Available in PDF, EPUB and Kindle. Book excerpt: