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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...
| Clasificación: | Libro Electrónico |
|---|---|
| Otros Autores: | , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
London :
Academic Press,
2012.
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| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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|---|---|---|---|
| 001 | SCIDIR_ocn789137615 | ||
| 003 | OCoLC | ||
| 005 | 20231117044717.0 | ||
| 006 | m o d | ||
| 007 | cr cn||||||||| | ||
| 008 | 120425s2012 enkaf obf 001 0 eng d | ||
| 040 | |a OPELS |b eng |e pn |c OPELS |d CDX |d CUX |d OCLCQ |d CHVBK |d OCLCF |d OCL |d OCLCQ |d U3W |d D6H |d WYU |d LEAUB |d S2H |d OCLCO |d OCLCQ |d OCLCO |d OCLCQ |d OCLCO | ||
| 019 | |a 1058085983 | ||
| 020 | |z 9780124157873 |q (p-ISBN) | ||
| 020 | |z 0124157874 |q (p-ISBN) | ||
| 035 | |a (OCoLC)789137615 |z (OCoLC)1058085983 | ||
| 043 | |a d------ | ||
| 050 | 4 | |a R853.C55 |b G56 2012 | |
| 082 | 0 | 4 | |a 616.02/7 |2 23 |
| 245 | 0 | 0 | |a Global clinical trials playbook : |b management and implementation when resources are limited / |c edited by Menghis Bairu, Richard Chin. |
| 260 | |a London : |b Academic Press, |c 2012. | ||
| 300 | |a 1 online resource (xii, 310 pages, 8 pages of plates) : |b illustrations | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 500 | |a Title from pdf title page (viewed July 11, 2012). | ||
| 504 | |a Includes bibliographical references and index. | ||
| 505 | 0 | |a 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. | |
| 520 | |a 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 | ||
| 650 | 0 | |a Clinical trials |v Handbooks, manuals, etc. | |
| 650 | 0 | |a Human experimentation in medicine |v Handbooks, manuals, etc. | |
| 650 | 1 | 2 | |a Clinical Trials as Topic |0 (DNLM)D002986 |
| 650 | 2 | |a Developing Countries |0 (DNLM)D003906 | |
| 650 | 6 | |a �Etudes cliniques |0 (CaQQLa)201-0070699 |v Guides, manuels, etc. |0 (CaQQLa)201-0377046 | |
| 650 | 6 | |a Exp�erimentation humaine en m�edecine |0 (CaQQLa)201-0070698 |v Guides, manuels, etc. |0 (CaQQLa)201-0377046 | |
| 650 | 7 | |a Clinical trials |2 fast |0 (OCoLC)fst00864429 | |
| 650 | 7 | |a Human experimentation in medicine |2 fast |0 (OCoLC)fst00963042 | |
| 655 | 2 | |a Handbook |0 (DNLM)D020479 | |
| 655 | 7 | |a manuals (instructional materials) |2 aat |0 (CStmoGRI)aatgf300026395 | |
| 655 | 7 | |a handbooks. |2 aat |0 (CStmoGRI)aatgf300311807 | |
| 655 | 7 | |a Handbooks and manuals |2 fast |0 (OCoLC)fst01423877 | |
| 655 | 7 | |a Handbooks and manuals. |2 lcgft | |
| 655 | 7 | |a Guides et manuels. |2 rvmgf |0 (CaQQLa)RVMGF-000001065 | |
| 700 | 1 | |a Bairu, Menghis. | |
| 700 | 1 | |a Chin, Richard Y. |q (Richard Yoonsik) | |
| 856 | 4 | 0 | |u https://sciencedirect.uam.elogim.com/science/book/9780124157873 |z Texto completo |