Global Clinical Trials Playbook: Capacity and Capability Building by Menghis BairuGlobal Clinical Trials Playbook: Capacity and Capability Building by Menghis Bairu

Global Clinical Trials Playbook: Capacity and Capability Building

byMenghis Bairu, Menghis Bairu, Richard Chin

Other | June 12, 2012

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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 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
Richard Chin is the CEO of Institute for OneWorld Health, the first U.S. nonprofit pharmaceutical company and Associate Professor at UCSF School of Medicine. OneWorld Health develops affordable drugs for neglected patients in the developing world. Dr. Chin has extensive expertise in drug development, including over 45 INDs and almost a...
Title:Global Clinical Trials Playbook: Capacity and Capability BuildingFormat:OtherDimensions:320 pages, 1 × 1 × 1 inPublished:June 12, 2012Publisher:Elsevier ScienceLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0124158609

ISBN - 13:9780124158603


Table of Contents

Section 1: Clinical Trials1. Introduction 2. Global Clinical Trials: Study Design and Planning 3. Building a Healthy Mechanism for Good Clinical Practice-Compliant Global Trials: African Perspectives 4. Clinical Trial Sites Capabilities: Standard Operating Procedure Implementation in Effective African Models 5. How to Select and Oversee Contract Research Organizations 6. The How-To of Global Clinical Trial Forecasting, Budgeting and Project Management

Section 2: Strengthening and Building Clinical Trial Site Capabilities and Capacity in Developing and Emerging Markets

7. Lessons Learned in India 8. Lessons Learned in China 9. Lessons Learned in Eastern Europe 10. Lessons Learned in Singapore 11. Lessons Learned in Turkey

Section 3: Regulatory Capacity12. Development of Regulatory Capacity in Monitoring, Oversight, Enforcement, and Approval of Clinical Trials: Taiwan's Experience as an Example

Section 4: How to Build and Enhance Pharmacovigilance and Risk Management Capacity and Capability13. Pharmacovigilance and Risk Management

Section 5: Electronic Data Capture14. Setting up Electronic Data Capture Capabilities

Section 6: Ethics, Human Resources, and Intellectual Property15. Ethics and International Review Board Capacity Building

Section 7: Quality Assurance and Data Management16. Clinical Quality Assurance and Data Management

Appendix A - Sample Protocol Template Appendix B - Sample Informed Consent Form Appendix C - Sample Case Report Form Appendix D - Sample Statistical Analysis Plan Appendix E - Case Report Form Versioning Policy Appendix F - Checklist for Study Close-out Appendix G - Financial Disclosure Form