This engaging and non-technical guide to clinical trials covers issues study design, organization, management, analysis, recruitment, reporting, software, and monitoring. Free from the jargon-laden treatment of other books, A Manager’s Guide to the Design and Conduct Clinical Trials is built upon the formula of first planning, then implementing, and finally performing essential checks. Offers an executive level presentation of managerial guidelines as well as handy checklists accompanied by extracts from submitted protocols Includes checklists, examples, and tips, as well as a useful appendix on available software Covers e-submissions and use of computers for direct data acquisition Incorporates humorous yet instructive and true anecdotes to illustrate common pitfalls

Reprint of the original, first published in 1860.

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

Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios