Full 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.
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 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 Capacity
12. 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 Capability
13. Pharmacovigilance and Risk Management
Section 5: Electronic Data Capture
14. Setting up Electronic Data Capture Capabilities
Section 6: Ethics, Human Resources, and Intellectual Property
15. Ethics and International Review Board Capacity Building
Section 7: Quality Assurance and Data Management
16. 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
