In an arena which has seen rapid change over the past decade, this work provides a comprehensive and up-to-date guide to the planning, organization and management of clinical trials. The contributors are drawn from the pharmaceutical industry, from contact research organizations and from academia. The style is very accessible and this book could be used as a text by those new to clinical research and as a useful reference tool for those with more experience of this multidisciplinary, multinational, multibillion dollar industry. All aspects and all stages of clinical research are covered, including clinical trial design, protocol writing, case record form design, pharmacokinetics, selection of investigators and volunteers, safety issues, adverse reactions and monitoring, outcomes research, statistics, data management, archiving, audits and communication.
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Ignazio di Giovanna is Director of CCA2000 Ltd, East Horsley, UK, a Clinical Research Organization. Gareth Hayes is Executive Liaison Officer at the Institute of Clinical Research, Maidenhead, UK.
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