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Global clinical trialseffective impl...

Bairu, Menghis.

Global clinical trialseffective implementation and management /

Record Type:	Electronic resources : Monograph/item
Title/Author:	Global clinical trialsRichard Chin, Menghis Bairu [editors].
Reminder of title:	effective implementation and management /
other author:	Chin, Richard.
Published:	Amsterdam ;Academic Press,c2011.
Description:	1 online resource (xx, 501 p., [13] p. of col. plates.)
Notes:	Includes index.
Subject:	Clinical trialsDeveloping countries.
Online resource:	http://www.sciencedirect.com/science/book/9780123815378
ISBN:	9780123815378 (electronic bk.)

Global clinical trialseffective implementation and management /
Global clinical trialseffective implementation and management /[electronic resource] :Richard Chin, Menghis Bairu [editors]. - Amsterdam ;Academic Press,c2011. - 1 online resource (xx, 501 p., [13] p. of col. plates.)

Includes index.

Introduction Section I: Overview -- Section II: Clinical Study and Logistics -- Section III: Special Considerations in Conducting Trials in Developing Countries.

This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting Case studies outline successes, failures, lessons learned and prospects for future collaboration Includes country-specific guidelines for the most utilized countries Foreword by David Feigel, former Head of CDRH at FDA.

ISBN: 9780123815378 (electronic bk.)

Source: 1097461:10918551Elsevier Science & Technologyhttp://www.sciencedirect.comSubjects--Topical Terms:

571011
Clinical trials
--Developing countries.Index Terms--Genre/Form:

214472
Electronic books.

LC Class. No.: R853.C55 / G56 2011

Dewey Class. No.: 615.5072/4

Global clinical trialseffective implementation and management /
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520 $a This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting Case studies outline successes, failures, lessons learned and prospects for future collaboration Includes country-specific guidelines for the most utilized countries Foreword by David Feigel, former Head of CDRH at FDA.
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