Research Development Contracting
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Research and Development Contracting
Author | : 1962 Conference on United States Government Research, Development Contracts, George Washington University |
Publsiher | : Unknown |
Total Pages | : 0 |
Release | : 2024 |
Genre | : Electronic Book |
ISBN | : 0598374728 |
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A Report on Research and Development Contracting and Assistance
Author | : Anonim |
Publsiher | : Unknown |
Total Pages | : 100 |
Release | : 1993 |
Genre | : Contracting out |
ISBN | : NWU:35556023546708 |
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Research and Development Contracts
Author | : Anonim |
Publsiher | : Unknown |
Total Pages | : 116 |
Release | : 1976 |
Genre | : Medicine |
ISBN | : MINN:30000010682114 |
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Contract Research and Development Organizations
Author | : Shayne C. Gad,Charles B. Spainhour |
Publsiher | : Springer Science & Business Media |
Total Pages | : 212 |
Release | : 2011-08-04 |
Genre | : Medical |
ISBN | : 146140049X |
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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.
Research and Development in the United States Air Force
Author | : United States. Air Force. Air Research and Development Command |
Publsiher | : Unknown |
Total Pages | : 44 |
Release | : 1952 |
Genre | : Electronic Book |
ISBN | : UIUC:30112004358583 |
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Fiscal Year 1974 Authorization for Military Procurement Research and Development Construction Authorization for the Safeguard ABM and Active Duty and Selected Reserve Strengths
Author | : United States. Congress. Senate. Committee on Armed Services |
Publsiher | : Unknown |
Total Pages | : 472 |
Release | : 1973 |
Genre | : United States |
ISBN | : IND:30000090996954 |
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Contract Research and Development Organizations
Author | : Shayne C. Gad,Charles B. Spainhour |
Publsiher | : Unknown |
Total Pages | : 226 |
Release | : 2011-08-03 |
Genre | : Electronic Book |
ISBN | : 1461400503 |
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Guide to Contracting ITS Projects
Author | : Kenneth R. Marshall,Philip J. Tarnoff,National Cooperative Highway Research Program |
Publsiher | : Transportation Research Board |
Total Pages | : 47 |
Release | : 2006 |
Genre | : Intelligent Vehicle Highway Systems |
ISBN | : 9780309098489 |
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"TRB's National Cooperative Highway Research Program (NCHRP) Report 560: Guide to Contracting ITS Projects provides guidance on the procurement of intelligent transportation systems (ITS), including variable message signs, traffic detectors, signal controllers, and a variety of other hardware and software that entails applications of advanced electronics and information management to regulate and facilitate traffic flow. The report highlights best practices and recommends contracting strategies and contract types, terms, and conditions for ITS development, integration, system acceptance, warranty, maintenance, and upgrade. The research team that produced NCHRP Report 560 has also prepared NCHRP Web-Only Document 85: Considerations for a Guide to Contracting ITS Projects that describes their work and many interim results that may be of value to other researchers and professionals facing ITS procurement issues. In addition, the researchers developed an on-line tool that applies the NCHRP Report 560's decision-making process"--Publisher's description.