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.- 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
Table of Contents
Section 1: Clinical Trials 1. 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 ManagementSection 2: Strengthening and Building Clinical Trial Site Capabilities and Capacity in Developing and Emerging Markets7. Lessons Learned in India 8. Lessons Learned in China 9. Lessons Learned in Eastern Europe 10. Lessons Learned in Singapore 11. Lessons Learned in TurkeySection 3: Regulatory Capacity 12. Development of Regulatory Capacity in Monitoring, Oversight, Enforcement, and Approval of Clinical Trials: Taiwan's Experience as an ExampleSection 4: How to Build and Enhance Pharmacovigilance and Risk Management Capacity and Capability 13. Pharmacovigilance and Risk ManagementSection 5: Electronic Data Capture 14. Setting up Electronic Data Capture CapabilitiesSection 6: Ethics, Human Resources, and Intellectual Property 15. Ethics and International Review Board Capacity BuildingSection 7: Quality Assurance and Data Management 16. Clinical Quality Assurance and Data ManagementAppendix 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
