Global clinical trials: effective implementation and management
by Bairu, Menghis Chin, Richard
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 …
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- Full title :Global clinical trials : effective implementation and management / Richard Chin, Menghis Bairu [editors].
Summary
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.
Read More ↓Edition Statements
- Publication Date:©2011.
Publication Statements
- Publisher(s):Academic Press
- Place of Publication:Amsterdam
- Language:eng
- Publication Date:©2011.
The Physical Object
- Description:1 online resource (xx, 501 pages, [13] pages of color plates)
Edition Identifiers
- ISBN:9780123815378, 0123815371, 9780123815385, 012381538X
- oclc:ocn733938245
- LC Classification:R853.C55
- Dewey Decimal:615.5072/4
Table of Contents
Introduction Section I: Overview -- Section II: Clinical Study and Logistics -- Section III: Special Considerations in Conducting Trials in Developing Countries.
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