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Title:	商業計畫書- 臨床試驗夥伴學苑 Business Plan – ClinMate Acadamy
Authors:	王智欣 Wang, Chih-Hsin
Contributors:	何小台 Ho, Chester 王智欣 Wang, Chih-Hsin
Keywords:	臨床試驗臨床試驗專員臨床試驗協調者 Clinical Trial Clinical Research Associate (CRA) Clinical Research Coordinate (CTC)
Date:	2021
Issue Date:	2021-03-02 14:26:54 (UTC+8)
Abstract:	Clinical trial is the process of a human test in the drug development stage. The process is both costly and time-consuming. Cultivating clinical trial-related talents is conducive to the job seekers’ preparation in advance. For business owners, talent training also means more money saving and speed up for training development. Having accumulated over 15 years of clinical trial related work, we observed that the rapid increase in demand for CRCs/CRAs in Taiwan is deeply felt. However, the quality of talents has shown retarded growth. The main reason is that our clinical trials are still under the development stage compared to European countries and the United States where the environment is mature and the general public’s clinical trials have been accepted and popularized. Hence, the cultivation of outstanding and competitive clinical trial professionals has substantive value in enhancing the overall standards. Clinical trials in Taiwan have long undergone development, with a focus on Asian clinical trial markets and in the hope of keeping pace with international standards. Clinical trials are no longer mainstream only in European countries and the United States. How to ensure the sustainable development of Taiwan’s strengths and continue to foster clinical trial talents are our founding purposes.
Reference:	1. FDA website: https://www.fda.gov/patients/drug-development-process/step-3-clinical-research 2. CTC website: https://www.ccttt.org.tw/mooc/index.php 3. CRA definition: https://en.wikipedia.org/wiki/Clinical_research_associate 4. CRC definition: https://en.wikipedia.org/wiki/Clinical_research_coordinator 5. https://www.clinicalleader.com/doc/what-s-really-behind-the-cra-shortage-in-clinical-trials-a-root-cause-analysis-0001 6. Adam and Brantner (2006). Estimating the cost of drug development: Is it really 802 million dollars? Health Affairs (Millwood), 25(2), 420-428. 7. Kola and Landis (2004). Can the pharmaceutical industry reduce attrition rates? Nature Reviews, 3, 711-715. 8. Rho, Jay P. and Louie, Stan G. Handbook of Pharmaceutical Biotechnology. (New York: Pharmaceutical Products Press, 2003). 9. Schacter, Bernice. Biotechnology and Your Health: Pharmaceutical Applications. (Philadelphia: Chelsea House Publishers, 2006). 10. Speid, Lorna. Clinical Trials: What Patients and Healthy Volunteers Need to Know. (Oxford: Oxford University Press, 2010). 11. Zanders, Edward D. The Science and Business of Drugs Discovery: Demystifying the Jargon. (New York: Springer, 2011). 12. https://www.pfizer.com.tw/UPLOAD/Magzn/00000012/pdfpath/%E8%BC%9D%E7%91%9E%E6%9D%8F%E8%8B%91-%E7%AC%AC10%E6%9C%9F_small.pdf 13. Clinical trials in Asia: A World Health Organization database study. Sheraz Ali, Oluwaseun Egunsola, Zaheer Ud Din Babar, Syed Shahzad Hasan Perspect Clin Res. 2019 Jul-Sep; 10(3): 121–124 14. Moore T, Zhang H, Anderson G, Alexander GC. Estimated costs of pivotal trials for novel therapeutic agents approved the US Food and Drug Administration, 2015-2016 [published online September 24, 2018]. JAMA Intern Med.
Description:	碩士國立政治大學國際經營管理英語碩士學位學程(IMBA) 102933016
Source URI:	http://thesis.lib.nccu.edu.tw/record/#G0102933016
Data Type:	thesis
DOI:	10.6814/NCCU202100173
Appears in Collections:	[International MBA] Theses

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