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題名 臨床試驗委託研究機構價值單元、資源優勢、與策略之個案研究
A case study of value units, resource advantages, and strategy in a contract research organization
作者 黎西涵
貢獻者 彭朱如
黎西涵
關鍵詞 臨床試驗委託研究機構
策略
價值單元
資源優勢
日期 2011
上傳時間 30-Oct-2012 10:16:32 (UTC+8)
摘要 2010 年全球藥品銷售額約8800 億美金，並預估未來五年內，全球藥品市場規模可再成長3000 億美元，龐大的市場吸引許多生技製藥公司積極投入新藥的開發，但是製藥與審批程序日趨複雜，因此新藥上市必須仰賴專業分工。本研究臨床試驗委託研究機構，由於其提供生技製藥業臨床試驗研究支援，可加速新藥上市時程，是新藥開發價值鏈重要環節。
     台灣的臨床試驗委託研究機構自 1996 年至今，歷經產業環境從導入期進入成長期之外部環境變化快速，本研究採用個案研究法，以深入訪談、觀察等方式探討企業如何因應外部環境不斷調整策略方向，如何設計價值單元以及具備哪些內部及外部資源優勢，並據此提出未來實務建議。依據本研究提出的三個研究問題，經個案研究結果分析所得結論如下：
     一、 台灣臨床試驗委託研究機構產業環境變化，主要來自兩大因素：各國競爭及科技發展、成本考量造成的全球位移趨勢，以及臨床試驗相關法規的變更。因此策略方向初期以國內學名藥業務作為主力，隨著亞太區、生技醫藥技術發展與政府輔導等因素，策略轉向新藥開發臨床試驗的國際案件，並以策略聯盟方式加快開發業務速度。長期策略方向則是持續佈局國際市場並建立新的技術平台。
     二、 臨床試驗委託研究機構以九項價值單元組合完成嚴謹的臨床試驗經營流程，包括「業務開發」、「法規諮詢」、「專案管理」、「醫學撰寫」、「臨床監測」、「專業檢驗」、「資料管理」、「統計分析」、「結案報告」。不同階段的臨床試驗程序可能整合在同一價值單元，以創造最終價值。
     三、 各項價值單元之內部、外部資源分析結果顯示，臨床試驗委託研究機構歷經產業環境變化與策略調整，累積資源形成現有實體設備、關係、人力與經驗，可提供國際新藥開發臨床試驗案件服務，為企業策略發展基礎。
In 2010, global pharmaceutical sales is estimated to reach 880 billion US dollars and the market is expected to expand 300 billion US dollars further within 5 years. Such a huge market has attracted many bio-pharmaceutical companies to invest their assets in new drug research and development (ND R&D). However, the procedure of new drug production and application is getting more and more complicated, thus it depends on professional services to assist launching new drugs. A contract research organization, also called a clinical research organization (CRO), is an organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services to speed up launch timeline, and has played an important role in ND R&D value chain.
     Taiwan CRO industrial environment has went through from introduction period to growing period since 1996. External environment changes rapidly. This study adopts case study method, by in-depth interviews, observation etc. to explore how CRO companies continue to adjust strategy in response to the external environment, how to design value units and what internal and external resource advantages they have. The study also proposes future practice recommendations for CRO companies based on the results. To answer three research questions, the study result is concluded as follows:
     1. Taiwan CRO industry environment changes mainly from two factors: one is global displacement trend attributed to international competition, technology and cost. The other is changes in laws and regulations related to clinical trials. Therefore, the initial strategic direction focused on the domestic generic drug business. With the Asia Pacific biotechnology development and government guidance etc., it shifted to new drug international cases and strategic alliances. Long-term strategic direction is to focus on international market and to establish new technology platforms.
     2. Taiwan CRO uses 9 value units to constitute whole management process of clinical trials. These value units include: "sales development", "regulatory consulting", "project management", "medical writing", "clinical monitoring", "sample testing", "data management", "statistical analysis" and “final report". Different stages of clinical trial procedures may be integrated in the same value unit, in order to create the ultimate value.
     3. All value units’ internal and external resource analysis shows that Taiwan CRO accumulated resources such as physical facilities, relationships, human resources and experiences through industrial environment changes and strategy adjustment. These resources enable Taiwan CRO to provide new drug development services for international cases and this ability eventually became the foundation of corporate strategy.
書頁 I
     博碩士論文上網授權書 II
     學位考試委員會審定書（簽名頁） III
     中文摘要 IV
     英文摘要 V
     謝誌 VII
     目次 VIII
     圖目錄 X
     表目錄 XI
     第壹章 緒論 1
     第一節 研究動機 1
     第二節 研究目的與問題 4
     第三節 研究流程 5
     第貳章 文獻探討 6
     第一節 臨床試驗委託研究機構產業分析 6
     2.1.1 產業定義與範圍 6
     2.1.2 臨床試驗委託研究機構全球產業概況 11
     2.1.3 國內臨床試驗委託研究機構產業概況 12
     2.1.4 國內臨床試驗執行單位 14
     2.1.5 國內臨床試驗委託研究機構之策略管理相關文獻探討 18
     第二節 資源優勢相關文獻探討 20
     2.2.1 資源基礎理論 20
     2.2.2不確定環境之內部資源優勢 22
     2.2.3資源分類：內部資源、外部資源 24
     第三節 經營流程與價值單元相關文獻探討 26
     2.3.1 價值活動 26
     2.3.2 經營流程 27
     2.3.3 價值單元 28
     第叁章 研究方法 29
     第一節 研究範圍 29
     第二節 研究架構 31
     第三節 研究設計與資料來源說明 32
     3.3.1 研究設計 32
     3.3.2資料來源說明 32
     第肆章 研究結果 35
     第一節 個案公司簡介 35
     第二節 各階段之產業環境與經營策略 38
     第三節 個案公司臨床試驗之經營流程 50
     第四節 價值單元設計與各價值單元之資源優勢 53
     第伍章 結論與建議 65
     第一節 結論 65
     第二節 實務與未來研究建議 71
     5.2.1 實務的建議 71
     5.2.2 研究限制 73
     5.2.3 未來研究建議 73
     參考文獻與書目 74
參考文獻 參考文獻與書目
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     5. 林志六、林勇良、王玫、王薏雯，(2008)，「新藥開發與臨床試驗(POD)」，秀威資訊。
     6. 洪義容，(2004)，台灣臨床委託試驗機構競爭力之研究，國立中山大學國際高階經營管理碩士學程未出版碩士論文。
     7. 洪錫娟，(2005)，台灣發展醫藥研發服務產業之探討-以臨床試驗部分為例，國立政治大學科技管理研究所未出版碩士論文。
     8. 財團法人生物技術開發中心，(2001)，「臨床試驗體系委外現況」，財團法人生物技術開發中心產業報告。
     9. 高新發，(2000)，台灣本土藥廠技術策略建構與經營策略之探討(以生達製藥公司為例)，國立中山大學高階經營碩士學程未出版碩士論文。
     10. 莊其穆，(2011)，臨床醫師如何執行第一期臨床試驗，台灣醫界，54(4)，頁 21-30。
     11. 陳文欽、溫源鳳、蘇育敏，(2004)，從資源基礎理論探討醫療產業經營關鍵成功因素-策略矩陣分析法之應用，遠東學報，21(3)。
     12. 黃思遠，(2010)，生物技術服務業風險與失敗因素之研究-以台灣委託研發機構為例，國立中興大學科技管理研究所未出版碩士論文。
     13. 劉祖惠、秦慶瑤，(2010)，「中國大陸產業現況及兩岸競合關係-中草藥產業、CRO產業」，財團法人生物技術開發中心產業報告。
     14. Cooper, D.R., Schindler, P.S.，古永嘉,楊雪蘭編譯，(2009)，「企業硏究方法」，華泰書局。
     (二) 英文資料來源
     15. Allee, V. (2008). Value network analysis and value conversion of tangible and intangible assets. Journal of Intellectual Capital, 9(1), pp. 5-24.
     16. Audretsch, B.D. (1995). Innovation, growth and survival. International Journal of Industrial Organization, 13(4), pp. 441-457.
     17. Barney, J. (1991). Firm resources and sustained competitive advantage. Journal of Management, 17(1), pp. 9-120.
     18. Berghman, L., Matthyssens, P. and Vandenbempt, K. (2006). Building competences for new customer value creation: An exploratory study. Industrial Marketing Management, 35(8), pp. 961-973.
     19. Burgess, F.T. (1994). Making the leap to agility: Defining and achieving agile manufacturing through business process redesign and business network redesign. International Journal of Operations & Production Management, 14(11), pp. 23-34.
     20. Eisenhardt, K. and Martin, J. (2000). Dynamic capabilities: what are they? Strategic Management Journal, 21, pp. 1105-1121.
     21. Grant, R. M. (1991). The resource-based theory of competitive advantage: implications for strategy formulation. California Management Review, 33(3), pp. 114-135.
     22. Hagel, J. III. and Singer, M. (1999). Unbundling the corporation. Harvard Business Review, 77(2), pp. 133-141.
     23. Hamel G. and Prahalad, C. K. (1994). Competing for the Future. Boston: Harvard Business Press.
     24. Hammer, M. and Champy, J. (1993). Reengineering the Corporation: a Manifesto for Business Revolution. New York: HarperCollins.
     25. Hayward, M. L. A. (2002). When do firms learn from their acquisition experience? Evidence from 1990 to 1995. Strategic Management Journal, 23(1), pp. 21-39.
     26. Hergert, M. and Morris, D. (1989). Accounting data for value chain analysis. Strategic Management Journal, 10, pp. 175-188.
     27. Hirschmann, W. (1964, Jan). Profit from the Learning Curve. Harvard Business Review, pp. 105-119.
     28. Ho, K.Y., Tjahjapranata, M. and Yap, C. M. (2006). Size, leverage, concentration, and R&D investment in generating growth opportunities. The Journal of Business, 79(2), pp. 851-876.
     29. Hoskisson, R. E. and Hitt, A.M. (1990). Antecedents and performance outcomes of diversification: A review and critique of theoretical perspectives. Journal of Management, 16(2), pp. 461-509.
     30. Hoskisson, R. E., Hitt, M. A., Wan, W. P. and Yiu, D. (1999). Theory and research in strategic management: Swings of a pendulum. Journal of Management, 25(3), pp. 417-456.
     31. Hunt, S. D. (2002). A General Theory of Competition. CA: Sage Publication.
     32. Leiblein, J. M. and Miller, D. J. (2003). An empirical examination of transaction and firm-level influences. Strategic Management Journal, 24(9), pp. 839-859.
     33. McGahan, A. M. and Porter, M. E. (1997). How much does industry matter really? Strategic Management Journal, 18(Summer Special Issue), pp. 15-30.
     34. McGrath, R. (2001). Exploratory learning, innovation capacity, and managerial oversight. Academy of Management Journal, 44(1), pp. 118-131.
     35. Penrose, E. T. (1959). The Theory of Growth of the Firm. New York: John Wiley.
     36. PeterafA.M. (1993). The cornerstones of competitive cdvantage: A resource-based view. Strategic Management Journal, 14(3), pp. 179-191.
     37. Pfeffer, J. and Salancik, G. (2003). The External Control of Organizations: A Resource Dependence Perspective. Stanford University Press.
     38. Porter, E.M. (1985). Competitive Advantage: Creating and Sustaining Superior Performance. New York: The Free Press.
     39. Prahalad, C. K. and Hamel, G. (1990). The Core Competence of the Corporation. Harvard Business Review, 68, pp. 79-91.
     40. Shane, S. and Venkataraman, S. (2000). The Promise of Entrepreneurship as a Field of Research. Academy of Management Review, 25(1), pp. 217-226.
     41. Sharma, A., Krishnan, R. and Grewal, D. (2001). Value creation in markets - A critical area of focus for business-to-business markets. Industrial Marketing Management, 30(4), pp. 391-402.
     42. Stabell, C. B.and Fjeldstad, Ø. (1998). Configuring value for competitive advantage: On chains, shops, and networks. Strategic Management Journal, 19(5), pp. 413-437.
     43. Teece, D. J., Pisano, G. and Shuen, A. (1997). Dynamic capabilities and strategic management. Strategic Management Journal, 19(7), pp. 509-533.
     44. Teng, J. T. C., Cheon, M. J.and Grover, V. (1995). Decisions to outsourcing information systems functions: Testing a strategy-theoretic discrepancy model. Decision Science, 26(1), pp. 75-103.
     45. Thompson, J. D. (1967). Organizations in Action. McGraw-Hill, New York.
     46. Wernerfelt, B. (1984). Resource-based view of the firm. Strategic Management Journal, 5, pp. 171-180.
     (三) 網路資料來源
     47. Winter, P. (2009, 3, 10). R&D Spending by U.S. Biopharmaceutical Companies increases 3 percent in 2008. Retrieved 7 21, 2011, from Burrill & Company: http://www.burrillandco.com/news-359-RD_Spending_by_US_Biopharmaceutical_Companies_increases_3_percent_in_2008_.html
     48. Koul, N.and Bhuller, R. (2010, 12). The Rising Dominance Of The Asian CRO Market. Retrieved 7 28, 2011, from Frost & Sullivan: http://www.slideshare.net/FrostandSullivan/frost-sullivan-the-rising-dominance-of-the-asian-cro-market
     49. Pettus, M. L., Kor, Y. Y. and Mahoney, J. T. (2007). A Theory of Change in Turbulent Environments: The Sequencing of Dynamic Capabilities Following Industry Deregulation. http://www.business.uiuc.edu/Working_Papers/papers/07-0100.pdf.
     50. The CRO Market Outlook:Emerging Markets, leading players and future trends. (2009, 8 27). Retrieved 7 28, 2011, from Business Insights: http://www.fiercebiotech.com/research/cro-market-outlook-emerging-markets-leading-players-and-future-trends
     51. 生物技術開發中心整理，(2010年9月3日)，生物技術/醫藥服務業，2011年7月28日擷取自生技醫藥產業智網: http://biokin.itis.org.tw/news/P2_FreeNewsFocusDetail.aspx?fcs_id=497928132
     52. 財團法人國家實驗研究院科技政策研究與資訊中心，(2005年9月22日)，生技製藥CRO所扮演之角色， 2011年07月28日擷取自 STPI: http://cdnet.stpi.org.tw/techroom/market/bio/bio038.htm
     53. 海峽生技醫藥風雲. (2011年5月15日). 2011年7月28日 擷取自 http://alveice.blogspot.com/2011_05_09_archive.html
描述 碩士
國立政治大學
管理碩士學程(AMBA)
99380004
100
資料來源 http://thesis.lib.nccu.edu.tw/record/#G0099380004
資料類型 thesis
dc.contributor.advisor 彭朱如zh_TW
dc.contributor.author (Authors) 黎西涵zh_TW
dc.creator (作者) 黎西涵zh_TW
dc.date (日期) 2011en_US
dc.date.accessioned 30-Oct-2012 10:16:32 (UTC+8)-
dc.date.available 30-Oct-2012 10:16:32 (UTC+8)-
dc.date.issued (上傳時間) 30-Oct-2012 10:16:32 (UTC+8)-
dc.identifier (Other Identifiers) G0099380004en_US
dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/54208-
dc.description (描述) 碩士zh_TW
dc.description (描述) 國立政治大學zh_TW
dc.description (描述) 管理碩士學程(AMBA)zh_TW
dc.description (描述) 99380004zh_TW
dc.description (描述) 100zh_TW
dc.description.abstract (摘要) 2010 年全球藥品銷售額約8800 億美金，並預估未來五年內，全球藥品市場規模可再成長3000 億美元，龐大的市場吸引許多生技製藥公司積極投入新藥的開發，但是製藥與審批程序日趨複雜，因此新藥上市必須仰賴專業分工。本研究臨床試驗委託研究機構，由於其提供生技製藥業臨床試驗研究支援，可加速新藥上市時程，是新藥開發價值鏈重要環節。
     台灣的臨床試驗委託研究機構自 1996 年至今，歷經產業環境從導入期進入成長期之外部環境變化快速，本研究採用個案研究法，以深入訪談、觀察等方式探討企業如何因應外部環境不斷調整策略方向，如何設計價值單元以及具備哪些內部及外部資源優勢，並據此提出未來實務建議。依據本研究提出的三個研究問題，經個案研究結果分析所得結論如下：
     一、 台灣臨床試驗委託研究機構產業環境變化，主要來自兩大因素：各國競爭及科技發展、成本考量造成的全球位移趨勢，以及臨床試驗相關法規的變更。因此策略方向初期以國內學名藥業務作為主力，隨著亞太區、生技醫藥技術發展與政府輔導等因素，策略轉向新藥開發臨床試驗的國際案件，並以策略聯盟方式加快開發業務速度。長期策略方向則是持續佈局國際市場並建立新的技術平台。
     二、 臨床試驗委託研究機構以九項價值單元組合完成嚴謹的臨床試驗經營流程，包括「業務開發」、「法規諮詢」、「專案管理」、「醫學撰寫」、「臨床監測」、「專業檢驗」、「資料管理」、「統計分析」、「結案報告」。不同階段的臨床試驗程序可能整合在同一價值單元，以創造最終價值。
     三、 各項價值單元之內部、外部資源分析結果顯示，臨床試驗委託研究機構歷經產業環境變化與策略調整，累積資源形成現有實體設備、關係、人力與經驗，可提供國際新藥開發臨床試驗案件服務，為企業策略發展基礎。		zh_TW
dc.description.abstract (摘要) In 2010, global pharmaceutical sales is estimated to reach 880 billion US dollars and the market is expected to expand 300 billion US dollars further within 5 years. Such a huge market has attracted many bio-pharmaceutical companies to invest their assets in new drug research and development (ND R&D). However, the procedure of new drug production and application is getting more and more complicated, thus it depends on professional services to assist launching new drugs. A contract research organization, also called a clinical research organization (CRO), is an organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services to speed up launch timeline, and has played an important role in ND R&D value chain.
     Taiwan CRO industrial environment has went through from introduction period to growing period since 1996. External environment changes rapidly. This study adopts case study method, by in-depth interviews, observation etc. to explore how CRO companies continue to adjust strategy in response to the external environment, how to design value units and what internal and external resource advantages they have. The study also proposes future practice recommendations for CRO companies based on the results. To answer three research questions, the study result is concluded as follows:
     1. Taiwan CRO industry environment changes mainly from two factors: one is global displacement trend attributed to international competition, technology and cost. The other is changes in laws and regulations related to clinical trials. Therefore, the initial strategic direction focused on the domestic generic drug business. With the Asia Pacific biotechnology development and government guidance etc., it shifted to new drug international cases and strategic alliances. Long-term strategic direction is to focus on international market and to establish new technology platforms.
     2. Taiwan CRO uses 9 value units to constitute whole management process of clinical trials. These value units include: "sales development", "regulatory consulting", "project management", "medical writing", "clinical monitoring", "sample testing", "data management", "statistical analysis" and “final report". Different stages of clinical trial procedures may be integrated in the same value unit, in order to create the ultimate value.
     3. All value units’ internal and external resource analysis shows that Taiwan CRO accumulated resources such as physical facilities, relationships, human resources and experiences through industrial environment changes and strategy adjustment. These resources enable Taiwan CRO to provide new drug development services for international cases and this ability eventually became the foundation of corporate strategy.		en_US
dc.description.abstract (摘要) 書頁 I
     博碩士論文上網授權書 II
     學位考試委員會審定書（簽名頁） III
     中文摘要 IV
     英文摘要 V
     謝誌 VII
     目次 VIII
     圖目錄 X
     表目錄 XI
     第壹章 緒論 1
     第一節 研究動機 1
     第二節 研究目的與問題 4
     第三節 研究流程 5
     第貳章 文獻探討 6
     第一節 臨床試驗委託研究機構產業分析 6
     2.1.1 產業定義與範圍 6
     2.1.2 臨床試驗委託研究機構全球產業概況 11
     2.1.3 國內臨床試驗委託研究機構產業概況 12
     2.1.4 國內臨床試驗執行單位 14
     2.1.5 國內臨床試驗委託研究機構之策略管理相關文獻探討 18
     第二節 資源優勢相關文獻探討 20
     2.2.1 資源基礎理論 20
     2.2.2不確定環境之內部資源優勢 22
     2.2.3資源分類：內部資源、外部資源 24
     第三節 經營流程與價值單元相關文獻探討 26
     2.3.1 價值活動 26
     2.3.2 經營流程 27
     2.3.3 價值單元 28
     第叁章 研究方法 29
     第一節 研究範圍 29
     第二節 研究架構 31
     第三節 研究設計與資料來源說明 32
     3.3.1 研究設計 32
     3.3.2資料來源說明 32
     第肆章 研究結果 35
     第一節 個案公司簡介 35
     第二節 各階段之產業環境與經營策略 38
     第三節 個案公司臨床試驗之經營流程 50
     第四節 價值單元設計與各價值單元之資源優勢 53
     第伍章 結論與建議 65
     第一節 結論 65
     第二節 實務與未來研究建議 71
     5.2.1 實務的建議 71
     5.2.2 研究限制 73
     5.2.3 未來研究建議 73
     參考文獻與書目 74		-
dc.description.tableofcontents 書頁 I
     博碩士論文上網授權書 II
     學位考試委員會審定書（簽名頁） III
     中文摘要 IV
     英文摘要 V
     謝誌 VII
     目次 VIII
     圖目錄 X
     表目錄 XI
     第壹章 緒論 1
     第一節 研究動機 1
     第二節 研究目的與問題 4
     第三節 研究流程 5
     第貳章 文獻探討 6
     第一節 臨床試驗委託研究機構產業分析 6
     2.1.1 產業定義與範圍 6
     2.1.2 臨床試驗委託研究機構全球產業概況 11
     2.1.3 國內臨床試驗委託研究機構產業概況 12
     2.1.4 國內臨床試驗執行單位 14
     2.1.5 國內臨床試驗委託研究機構之策略管理相關文獻探討 18
     第二節 資源優勢相關文獻探討 20
     2.2.1 資源基礎理論 20
     2.2.2不確定環境之內部資源優勢 22
     2.2.3資源分類：內部資源、外部資源 24
     第三節 經營流程與價值單元相關文獻探討 26
     2.3.1 價值活動 26
     2.3.2 經營流程 27
     2.3.3 價值單元 28
     第叁章 研究方法 29
     第一節 研究範圍 29
     第二節 研究架構 31
     第三節 研究設計與資料來源說明 32
     3.3.1 研究設計 32
     3.3.2資料來源說明 32
     第肆章 研究結果 35
     第一節 個案公司簡介 35
     第二節 各階段之產業環境與經營策略 38
     第三節 個案公司臨床試驗之經營流程 50
     第四節 價值單元設計與各價值單元之資源優勢 53
     第伍章 結論與建議 65
     第一節 結論 65
     第二節 實務與未來研究建議 71
     5.2.1 實務的建議 71
     5.2.2 研究限制 73
     5.2.3 未來研究建議 73
      參考文獻與書目 74		zh_TW
dc.language.iso en_US-
dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0099380004en_US
dc.subject (關鍵詞) 臨床試驗委託研究機構zh_TW
dc.subject (關鍵詞) 策略zh_TW
dc.subject (關鍵詞) 價值單元zh_TW
dc.subject (關鍵詞) 資源優勢zh_TW
dc.title (題名) 臨床試驗委託研究機構價值單元、資源優勢、與策略之個案研究zh_TW
dc.title (題名) A case study of value units, resource advantages, and strategy in a contract research organizationen_US
dc.type (資料類型) thesisen
dc.relation.reference (參考文獻) 參考文獻與書目
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