Global clinical trials playbook: management and implementation when resources are limited

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 devicesto market. Because of timeline pressures and cost as well asthe 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 thisup-to-date,step-by-step guide book tobuilding and enhancingglobal clinical trial capacity inemerging markets anddeveloping countries. This book covers the design, conduct,and tools to build and/or enhance human capacity to executesuch trials, appealing toindividualsin health ministries,pharmaceutical companies, world health organizations,academia, industry,and non-governmental organizations (NGOs) who are managing global clinical trials. Givesmedical professionals the businesstools 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 ina number of global scenarios

• ISBN: 978-0-12-415787-3
• Editorial: Academic Press
• Encuadernacion: Cartoné
• Fecha Publicación: 12/06/2012
• Nº Volúmenes: 1
• Idioma: Inglés