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題名 商業計畫書- 臨床試驗夥伴學苑
Business Plan – ClinMate Acadamy
作者 王智欣
Wang, Chih-Hsin
貢獻者 何小台
Ho, Chester
王智欣
Wang, Chih-Hsin
關鍵詞 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)
日期 2021
上傳時間 2-Mar-2021 14:26:54 (UTC+8)
摘要 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.
參考文獻 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.
描述 碩士
國立政治大學
國際經營管理英語碩士學位學程(IMBA)
102933016
資料來源 http://thesis.lib.nccu.edu.tw/record/#G0102933016
資料類型 thesis
dc.contributor.advisor 何小台zh_TW
dc.contributor.advisor Ho, Chesteren_US
dc.contributor.author (Authors) 王智欣zh_TW
dc.contributor.author (Authors) Wang, Chih-Hsinen_US
dc.creator (作者) 王智欣zh_TW
dc.creator (作者) Wang, Chih-Hsinen_US
dc.date (日期) 2021en_US
dc.date.accessioned 2-Mar-2021 14:26:54 (UTC+8)-
dc.date.available 2-Mar-2021 14:26:54 (UTC+8)-
dc.date.issued (上傳時間) 2-Mar-2021 14:26:54 (UTC+8)-
dc.identifier (Other Identifiers) G0102933016en_US
dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/134056-
dc.description (描述) 碩士zh_TW
dc.description (描述) 國立政治大學zh_TW
dc.description (描述) 國際經營管理英語碩士學位學程(IMBA)zh_TW
dc.description (描述) 102933016zh_TW
dc.description.abstract (摘要) 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.		en_US
dc.description.tableofcontents 1. EXECUTIVE SUMMARY 1
2. OVERVIEW OF NEW DRUG DEVELOPMENT PROCESS 4
2.1. CLINICAL TRIALS 4
2.2. CLINICAL RESEARCH ASSOCIATE (CRA) 6
2.3. CLINICAL RESEARCH COORDINATE/NURSE (CRC) / (CRN) 7
2.4. PROBLEM & SOLUTION 7
2.4.1. Problem Worth Solving 7
2.4.2. Our Solutions 8
3. MARKET ANALYSIS 9
3.1. CLINICAL TRIAL NUMBER DATABASE NAVIGATION 9
3.2. TALENT SEARCH DATABASE NAVIGATION 13
3.3. COMPETITORS 16
4. EXECUTION - CLINMATE ACADEMY 18
4.1. MARKET SEGMENT 1- COURSE PLANNING OF CLINMATE IS SHOWN BELOW: 21
4.2. MARKET SEGMENT 2- CLINMATE MATCHES BUSINESSES AND CRA TALENT- THIS IS OUR SECONDARY REVENUE UNIT. 23
4.3. DEDICATE TRAINER 24
4.4. LOCATION & FACILITY 25
4.5. PRICE/TUITION 25
4.6. SALES PLAN 25
4.7. EQUIPMENT, TOOLS, LOCATION 26
4.8. COURSE CONSULTATION & PROMOTION 26
5. CLINMATE ACADEMY VISION AND MISSION 27
5.1. VISION 27
5.2. MISSION 27
6. STRATEGIC PLANNING 28
6.1. STRENGTH OF CLINMATE 28
6.2. OPPORTUNITY OF CLINMATE 28
6.3. THREAT OF CLINMATE 28
6.4. WEAKNESS OF CLINMATE 28
7. FINANCIAL 29
7.1. INITIAL INVESTMENT & OPERATIONS COST 29
7.2. REVENUE 29
7.3. FIRST THREE YEARS INCOME STATEMENT AND BALANCE SHEET 29
8. REFERENCE 33		zh_TW
dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0102933016en_US
dc.subject (關鍵詞) 臨床試驗zh_TW
dc.subject (關鍵詞) 臨床試驗專員zh_TW
dc.subject (關鍵詞) 臨床試驗協調者zh_TW
dc.subject (關鍵詞) Clinical Trialen_US
dc.subject (關鍵詞) Clinical Research Associate (CRA)en_US
dc.subject (關鍵詞) Clinical Research Coordinate (CTC)en_US
dc.title (題名) 商業計畫書- 臨床試驗夥伴學苑zh_TW
dc.title (題名) Business Plan – ClinMate Acadamyen_US
dc.type (資料類型) thesisen_US
dc.relation.reference (參考文獻) 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.		zh_TW
dc.identifier.doi (DOI) 10.6814/NCCU202100173en_US