A Report on Research and Development Contracting and Assistance
Author :
Publisher :
Page : 100 pages
File Size : 42,63 MB
Release : 1993
Category : Contracting out
ISBN :
Contract Research and Development Organizations
Author : Shayne C. Gad
Publisher : Springer Science & Business Media
Page : 213 pages
File Size : 16,96 MB
Release : 2011-08-04
Category : Medical
ISBN : 146140049X
Book Description
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.
Allocating Federal Funds for Science and Technology
Author : National Research Council
Publisher : National Academies Press
Page : 107 pages
File Size : 23,97 MB
Release : 1995-11-22
Category : Political Science
ISBN : 030917600X
Book Description
The United States faces a new challengeâ€"maintaining the vitality of its system for supporting science and technology despite fiscal stringency during the next several years. To address this change, the Senate Appropriations Committee requested a report from the National Academies of Sciences and Engineering and the Institute of Medicine to address "the criteria that should be used in judging the appropriate allocation of funds to research and development activities; to examine the appropriate balance among different types of institutions that conduct such research; and to look at the means of assuring continued objectivity in the allocation process." In this eagerly-awaited book, a committee of experts selected by the National Academies and the Institute responds with 13 recommendations that propose a new budgeting process and formulates a series of questions to address during that process. The committee also makes corollary recommendations about merit review, government oversight, linking research and development to government missions, the synergy between research and education, and other topics. The recommendations are aimed at rooting out obsolete and inadequate activities to free resources from good programs for even better ones, in the belief that "science and technology will be at least as important in the future as they have been in the past in dealing with problems that confront the nation." The authoring committee of this book was chaired by Frank Press, former President of the National Academy of Sciences (1981-1993) and Presidential Science and Technology Advisor (1977-1981).
Circular No. A-11
Author : Omb
Publisher :
Page : 534 pages
File Size : 11,39 MB
Release : 2019-06-29
Category :
ISBN : 9781077077607
Book Description
The June 2019 OMB Circular No. A-11 provides guidance on preparing the FY 2021 Budget and instructions on budget execution. Released in June 2019, it's printed in two volumes. This is Volume I. Your budget submission to OMB should build on the President's commitment to advance the vision of a Federal Government that spends taxpayer dollars more efficiently and effectively and to provide necessary services in support of key National priorities while reducing deficits. OMB looks forward to working closely with you in the coming months to develop a budget request that supports the President's vision. Most of the changes in this update are technical revisions and clarifications, and the policy requirements are largely unchanged. The summary of changes to the Circular highlights the changes made since last year. This Circular supersedes all previous versions. VOLUME I Part 1-General Information Part 2-Preparation and Submission of Budget Estimates Part 3-Selected Actions Following Transmittal of The Budget Part 4-Instructions on Budget Execution VOLUME II Part 5-Federal Credit Part 6-The Federal Performance Framework for Improving Program and Service Delivery Part7-Appendices Why buy a book you can download for free? We print the paperback book so you don't have to. First you gotta find a good clean (legible) copy and make sure it's the latest version (not always easy). Some documents found on the web are missing some pages or the image quality is so poor, they are difficult to read. If you find a good copy, you could print it using a network printer you share with 100 other people (typically its either out of paper or toner). If it's just a 10-page document, no problem, but if it's 250-pages, you will need to punch 3 holes in all those pages and put it in a 3-ring binder. Takes at least an hour. It's much more cost-effective to just order the bound paperback from Amazon.com This book includes original commentary which is copyright material. Note that government documents are in the public domain. We print these paperbacks as a service so you don't have to. The books are compact, tightly-bound paperback, full-size (8 1/2 by 11 inches), with large text and glossy covers. 4th Watch Publishing Co. is a HUBZONE SDVOSB. https: //usgovpub.com
Report of the Activities
Author : United States. Congress. Joint Committee on Defense Production
Publisher :
Page : 1268 pages
File Size : 32,11 MB
Release : 1959
Category : Arms transfers
ISBN :
Book Description
Health Research
Author : Commission on Health Research for Development
Publisher : Oxford University Press, USA
Page : 170 pages
File Size : 15,72 MB
Release : 1990
Category : Medical
ISBN : 9780195208382
Book Description
Health and development. Funding research. Research priorities in developing countries, in industrialized countries and international centers. International research promotion. An agenda for action. Summary of specific-recommendations
Funding a Revolution
Author : National Research Council
Publisher : National Academies Press
Page : 300 pages
File Size : 45,23 MB
Release : 1999-02-11
Category : Computers
ISBN : 0309062780
Book Description
The past 50 years have witnessed a revolution in computing and related communications technologies. The contributions of industry and university researchers to this revolution are manifest; less widely recognized is the major role the federal government played in launching the computing revolution and sustaining its momentum. Funding a Revolution examines the history of computing since World War II to elucidate the federal government's role in funding computing research, supporting the education of computer scientists and engineers, and equipping university research labs. It reviews the economic rationale for government support of research, characterizes federal support for computing research, and summarizes key historical advances in which government-sponsored research played an important role. Funding a Revolution contains a series of case studies in relational databases, the Internet, theoretical computer science, artificial intelligence, and virtual reality that demonstrate the complex interactions among government, universities, and industry that have driven the field. It offers a series of lessons that identify factors contributing to the success of the nation's computing enterprise and the government's role within it.
Contract Pricing Reference Guides
Author : Wolters Kluwer
Publisher : CCH
Page : 0 pages
File Size : 41,1 MB
Release : 2016-05-10
Category : Business & Economics
ISBN : 9781454880714
Book Description
This new, single-volume resource provides the most complete guidance available for analyzing the cost and pricing aspects of federal government contracts--so you can propose and negotiate appropriate prices and win contracts. The practical Contract Pricing Reference Guide reference combines five manuals into a single source, covering: Price Analysis Quantitative Techniques for Contract Pricing Cost Analysis Advanced Issues in Contract Pricing And Federal Contract Negotiation Techniques Determine the Proper Pricing to Win Government Business Throughout these pages, you will find highly detailed explanations of how the government evaluates proposals, arrives at pricing, chooses contractors, and awards contracts. With Contract Pricing Reference Guide, you can more confidently: Conduct market research for price analysis Employ proven techniques of quantitative price analysis Propose a fair and appropriate price Confidently engage in sealed bidding Include only what's allowable in the price Employ the most effective, competitive pricing strategies And engage in effective contract negotiations The One-of-a-Kind, Time-Saving Pricing Resource The all-new Contract Pricing Reference Guide provides a road-map for how to set correct pricing and engage in the competitive bidding process. It is a practical business tool to help you acquire government contract business--and it brings all the most valuable pricing information together in an easy-access, single-volume resource that puts everything you need literally right in front of you. No other resource delivers all of this together in one place, making it the most convenient way to obtain the most vital information on pricing government contracts.
A.I.D. Research and Development Abstracts
Author :
Publisher :
Page : 1136 pages
File Size : 48,23 MB
Release : 1976
Category : Economic development
ISBN :
Book Description
The Belmont Report
Author : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher :
Page : 614 pages
File Size : 40,63 MB
Release : 1978
Category : Ethics, Medical
ISBN :
