Global clinical trials playbook : management and implementation when resources are limited /

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 "neglect...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Bairu, Menghis, Chin, Richard Y. (Richard Yoonsik)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: London : Academic Press, 2012.
Temas:
Clinical trials > Handbooks, manuals, etc.
Human experimentation in medicine > Handbooks, manuals, etc.
Clinical Trials as Topic
Developing Countries
�Etudes cliniques > Guides, manuels, etc.
Exp�erimentation humaine en m�edecine > Guides, manuels, etc.
Clinical trials
Human experimentation in medicine
Handbook
manuals (instructional materials)
handbooks.
Handbooks and manuals
Handbooks and manuals.
Guides et manuels.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Section 1. Clinical trials. Chapter 1. Introduction
  • Chapter 2. Global clinical trials: study design and planning
  • Chapter 3. Building a healthy mechanism for good clinical practice-compliant global trials: African perspectives
  • Chapter 4. Clinical trial sites capabilities: standard operating procedure implementation in effective African models
  • Chapter 5. How to select and oversee contract research organizations
  • Chapter 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. Chapter 7. Lessons learned in India
  • Chapter 8. Lessons learned in China
  • Chapter 9. Lessons learned in Eastern Europe
  • Chapter 10. Lessons learned in Singapore
  • Chapter 11. Lessons learned in Turkey
  • Section 3. Regulatory capacity. Chapter 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. Chapter 13. Pharmacovigilance and risk management
  • Section 5. Electronic data capture. Chapter 14. Setting up electronic data capture capabilities
  • Section 6. Ethics, human resources, and intellectual property. Chapter 15. Ethics and institutional review board capacity building
  • Section 7. Quality assurance and data management. Chapter 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 versioining policy
  • Appendix F. Checklist for study close-out
  • Appendix G. Financial disclosure form
  • Index
  • Color plates.

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