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.