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 qneglected diseasesq 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 scenariosJuncai (Jack) Xu*, Zhijie Xiay *Shanghai Clinical Research Center, Shanghai, China yICU Department, Shanghai ... Good clinical practice (GCP) in China can be traced back to 1984, when the Law on Drug Administration included someanbsp;...
|Title||:||Global Clinical Trials Playbook|
|Author||:||Menghis Bairu, Richard Chin|
|Publisher||:||Academic Press - 2012|