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" Outsourcing in clinical drug development / "
Roy Drucker and Graham Hughes, editors.
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BL
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| Record Number
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1041040
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| Doc. No
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b795410
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| Title & Author
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Outsourcing in clinical drug development /\ Roy Drucker and Graham Hughes, editors.
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| Publication Statement
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Englewood, Colo. :: Interpharm Press,, ©2002.
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| Page. NO
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1 online resource (x, 258 pages) :: illustrations
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| ISBN
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1420026003
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: 9781420026009
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1574911120
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9781574911121
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| Bibliographies/Indexes
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Includes bibliographical references and index.
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| Contents
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1. Suppliers to healthcare R & D / Graham Hughes -- 2. The sourcing decision / Roy Drucker -- 3. Supplier identification, evaluation, and selection / Tim Wright -- 4. Financial and organizational outsourcing considerations / Nadia Turner and Chris Keep -- 5. Clinical research contracting : a legal perspective / Paul Ranson -- 6. Ethical considerations in outsourced clinical trials / Richard Ashcroft -- 7. Avoiding and managing conflict in outsourcing clinical research / Lucien Steru -- 8. The role of site management organizations / Rakesh Nath -- 9. Clinical trial supplies : the vital link / Patricia Lobo -- 10. Contracting out laboratory analysis / Ann Speaight -- 11. Contracting data management and statistical services / Jacqui Spencer -- 12. Global clinical trials : the cultural challenge / Madeline J. Ducate -- 13. Outsourcing and the use of contract quality assurance / Nigel J. Dent -- 14. Contracting out regulatory projects to a regulatory CRO / Gillian Gregory and John Glasby -- 15. Trends in pharmaceutical development outsourcing / Jeffrey S. Rudolph and Joseph S. Tempio.
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| Abstract
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Sponsor companies and CROs alike will appreciate the industry-wide analysis, practical, how-to advice, and helpful charts and checklists provided by Outsourcing in Clinical Drug Development. A panel of experts discuss supplier identification and selection, financial considerations, and the ethical issues. They cover contracting out laboratory analysis, data management, and statistical services, and the effects of outsourcing on quality assurance. Whether readers are beginning to explore the possibility of outsourcing or already involved in long-term strategic outsourcing partnerships, this inv.
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| Subject
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Contracting out.
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Drug development.
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Drugs-- Research.
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Contracting out.
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Drug development.
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Drugs-- Research.
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MEDICAL-- Drug Guides.
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MEDICAL-- Nursing-- Pharmacology.
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MEDICAL-- Pharmacology.
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MEDICAL-- Pharmacy.
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Clinical Trials.
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Outsourced Services-- organization administration.
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Drug Industry.
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| Dewey Classification
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615/.19
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| LC Classification
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RM301.25.O94 2002eb
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| NLM classification
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2003 A-012
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QV 771O94 2002
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| Added Entry
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Drucker, Roy.
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Hughes, Graham,Ph.D.
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