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Author : Drug Information Association
Publisher :
ISBN 13 :
Total Pages : 237 pages
Book Rating : 4.:/5 (436 download)
Download or read book The DIA Contract Service Organization Directory written by Drug Information Association and published by . This book was released on 2000 with total page 237 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Shayne C. Gad
Publisher : Springer Nature
ISBN 13 : 3030430731
Total Pages : 515 pages
Book Rating : 4.0/5 (34 download)
Download or read book Contract Research and Development Organizations-Their History, Selection, and Utilization written by Shayne C. Gad and published by Springer Nature. This book was released on 2020-07-17 with total page 515 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics: · The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went. · Study directors and principal investigators. · The nuts and bolts of study performance. · Electronic reporting requirements – SEND and eCTD (required for NDA, BLA, ANDA, and IND submissions). · Consultants and their roles. · An expanded examination of common problems and their solutions. This book boasts complete directories to the global universe of operating labs – where they are, how to contact them, and what they do (including special capabilities). Additionally, checklists for qualifying labs and manufacturing facilities – and for auditing studies and projects at such facilities – are included. It is directed at those in industry (specifically directed at those working for companies using CRO services) but will also be of interest to scientists or administrators working in research organizations themselves. In this case, the contents of this new work are essential to the target reader because the work, regulations, and actors (CROs) have evolved and changed at a rapid pace in the 10 years since the earlier volume that the author published. Likewise, the companies using these services have come to all be almost completely dependent on outsourcing. The earlier texts remain the only source of their kind (paper or electronic) on the field and the only noncommercial guide to the global industry and this volume provides a complete update.
Author : Shayne C. Gad
Publisher : Springer Science & Business Media
ISBN 13 : 146140049X
Total Pages : 213 pages
Book Rating : 4.4/5 (614 download)
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.
Author : Shayne C. Gad
Publisher : CRC Press
ISBN 13 : 1134424868
Total Pages : 229 pages
Book Rating : 4.1/5 (344 download)
Download or read book The Selection and Use of Contract Research Organizations written by Shayne C. Gad and published by CRC Press. This book was released on 2003-07-03 with total page 229 pages. Available in PDF, EPUB and Kindle. Book excerpt: Choosing the right contract research organization (CRO) can make the difference between getting a product to market quickly and cost-effectively, and wasting valuable time and money. The vast number of available CROs is increasing all the time, and all of them make impressive claims. The Selection and Use of Contract Research Organizations is your
Author : United States. Defense Logistics Agency
Publisher :
ISBN 13 :
Total Pages : 238 pages
Book Rating : 4.:/5 (319 download)
Download or read book Headquarters Organization, Missions, and Functions written by United States. Defense Logistics Agency and published by . This book was released on 1984 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 1252 pages
Book Rating : 4.:/5 (31 download)
Download or read book Monthly Catalogue, United States Public Documents written by and published by . This book was released on 1984 with total page 1252 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Tracy Laquey
Publisher : Elsevier
ISBN 13 : 1483296415
Total Pages : 647 pages
Book Rating : 4.4/5 (832 download)
Download or read book The User's Directory of Computer Networks written by Tracy Laquey and published by Elsevier. This book was released on 2014-06-28 with total page 647 pages. Available in PDF, EPUB and Kindle. Book excerpt: Your map through the network jungle. Here's how to track down virtually every network available to academics and researchers. This new book, with its detailed compilation of host- level information, provides everything you need to locate resources, send mail to colleagues and friends worldwide, and answer questions about how to access major national and international networks. Extensively cross- referenced information on ARPANET/MILNET, BITNET, CSNET, Esnet, NSFNET, SPAN, THEnet, USENET, and loads of others is all provided. Included are detailed lists of hosts, site contacts, administrative domains, and organizations. Plus, a tutorial chapter with handy reference tables reveals electronic mail 'secrets' that make it easier to take advantage of networking.
Author :
Publisher :
ISBN 13 :
Total Pages : 628 pages
Book Rating : 4.3/5 (243 download)
Download or read book Monthly Catalog of United States Government Publications written by and published by . This book was released on 1983 with total page 628 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : United States. Armed Services Board of Contract Appeals
Publisher :
ISBN 13 :
Total Pages : 1630 pages
Book Rating : 4.3/5 (243 download)
Download or read book Board of Contract Appeals Decisions written by United States. Armed Services Board of Contract Appeals and published by . This book was released on 1998 with total page 1630 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : United States. Navy Department
Publisher :
ISBN 13 :
Total Pages : 278 pages
Book Rating : 4.:/5 (31 download)
Download or read book Department of the Navy RDT&E Management Guide written by United States. Navy Department and published by . This book was released on 1972 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 1854 pages
Book Rating : 4.3/5 (97 download)
Download or read book The Directory of Business Information Resources written by and published by . This book was released on 2008 with total page 1854 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 1012 pages
Book Rating : 4.F/5 ( download)
Download or read book The Code of Federal Regulations of the United States of America written by and published by . This book was released on 1986 with total page 1012 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.
Author :
Publisher :
ISBN 13 :
Total Pages : 1008 pages
Book Rating : 4.3/5 (91 download)
Download or read book Code of Federal Regulations written by and published by . This book was released on 1986 with total page 1008 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : United States. Navy Department
Publisher :
ISBN 13 :
Total Pages : 338 pages
Book Rating : 4.:/5 (31 download)
Download or read book RDT&E/acquisition Management Guide written by United States. Navy Department and published by . This book was released on 1989 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 1512 pages
Book Rating : 4.:/5 (334 download)
Download or read book Commerce Business Daily written by and published by . This book was released on 1997-12-31 with total page 1512 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Gail A. Schlachter
Publisher :
ISBN 13 :
Total Pages : 546 pages
Book Rating : 4.:/5 ( download)
Download or read book Directory of Financial Aids for Minorities, 1989-1990 written by Gail A. Schlachter and published by . This book was released on 1989 with total page 546 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 776 pages
Book Rating : 4.F/5 ( download)
Download or read book Federal Evaluations written by and published by . This book was released on with total page 776 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contains an inventory of evaluation reports produced by and for selected Federal agencies, including GAO evaluation reports that relate to the programs of those agencies.
