Cover for Global Clinical Trials Playbook

Global Clinical Trials Playbook

Management and Implementation when resources are limited

Book2012

Edited by:

Menghis Bairu and Richard Chin

Global Clinical Trials Playbook

Management and Implementation when resources are limited

Book2012

 

Cover for Global Clinical Trials Playbook

Edited by:

Menghis Bairu and Richard Chin

About the book

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Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valua ... read full description

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About the book

Description

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. 

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. 

Key Features

  • 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
  • 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

Details

ISBN

978-0-12-415787-3

Language

English

Published

2012

Copyright

Copyright © 2012 Elsevier Inc. All rights reserved

Imprint

Academic Press

Editors

Menghis Bairu

Elan Biopharmaceuticals, San Francisco, California, USA

Richard Chin

UCSF School of Medicine, San Francisco, California, USA