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
- Chapter 1- Introduction
- Chapter 2- Global Clinical Trials: study design and planning
- Chapter 3- Building a healthy mechanism for GCP compliant global trials: African perspectives
- Chapter 4- Clinical Trial sites capabilities: effective African models
- Chapter 5- Strengthening / building clinical trial site capabilities and capacity in developing/emerging markets.
- Chapter 6- How to select and oversee CROs
- Chapter 7- How to prioritize CTs based on national interest
- Chapter 8- The How to of Global Clinical Trial Forecasting, Budgeting, and Project Management
- Chapter 9- How to build-enhance Regulatory capacity to evaluate INDs and NDAs
- Chapter 10- Development of regulatory capacity in Monitoring, Oversight, Enforcement and approval of Clinical Trials
- Chapter 11- PharmacoVigilance and Risk Management
- Chapter 12- Setting up EDC capabilities
- Chapter 13- Ethics and IRB capacity building
- Chapter 14- Human resources planning and Job Descriptions
- Chapter 15- Ensuring intellectual property protection
- Chapter 16- Clinical Quality Assurance and Data Management
Menghis Bairu, Executive Vice President and General Manager, Elan Pharmaceuticals, South San Francisco, CA, USA
Richard Chin, CEO, Oxigene San Francisco, CA, USA