Global Clinical Trials Playbook. Management and Implementation when resources are limited Cover

Global Clinical Trials Playbook. Management and Implementation when resources are limited

ISBN/ASIN: 9780124157873 | 2012 | English | pdf | 294/294 pages | 19.4 Mb
Publisher: Academic Press | Author: Menghis Bairu and Richard Chin (Eds.)

''Global Clinical Trials: Effective Implementation andManagement is probably the most comprehensive book written to date on the topic. In 2008, 97 (80%) of 121 FDA marketing applications for drug and¿biological products included non-U.S. data, including 10 (8%) with no U.S. data. The book includes contributions¿from 59 authors, with coverage of¿many countries engaged in clinical research''–Clinical Research Best Practices''This is indeed a valuable resource with a broad range of regional experiences in clinical trials and touching a wide array of topics increasing the potential of target readers. I have truly found it quite informative.''Dr. Michael Makanga, Director South-South Cooperation and Head of Africa Office, European & Developing Countries Clinical Trials Partnership (EDCTP), South Africa''Global Clinical Trials Playbook is a treatise in self-learning, and a must read for researchers in academia, CROs, and NGOs involved in funding and conducting clinical trials. It is a vital reference for those interested in capacity building in clinical research, especially in developing countries.''Professor S. D. Seth, MD, FAMS, FNASc, FIPS, FCAI, FISCD, Advisor of Clinical Trials Registry – India, National Institute of Medical Statistics, Indian Council of Medical Research, New Delhi, India''This is an important book that comprehensively addresses capacity building across the globe. The breadth of the book and the broad array of geographies covered are impressive. This is a major publication that will push the field forward.''Dr. Dan Zhang, MD, PhD, Chairman & CEO of Fountain Medical Group, Shangai, China''Dr. Bairu and colleagues have produced the definitive reference guide to undertaking clinical trials around the world. I am sure that the Global Clinical Trials Playbook will instantly become an indispensable resource for funders and organisers of clinical trials who wish to stay up to date with the latest thinking in this fast moving field.''Dr. Rubin Minhas, M.B.Ch.B, Editor-in-Chief: ‘Clinical Evidence’, ‘Best Practice’ & Clinical Director, BMJ Evidence Centre''This book covers a broad range of topics important in global clinical trials and will be a welcome and comprehensive resource for professionals who are engaged in clinical trial related capacity building. It is a practical guide to conduct clinical trials in the new and uprising parts of the drug development world including Eastern Europe, Turkey, Singapore, India and China. The book goes hand in hand with global efforts to develop one global training concept for global drug development, the PharmaTrain Project. Learning by reading and doing for improved competency.''Fritz R. Bühler, Coordinator of IMI PharmaTrain, University of Basel, SwitzerlandCarl C. Peck, University of California San Francisco, UCSF, USABoth Founders of the European, American and Chinese Courses in Drug Development and Regulatory Sciences

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