在生技服務產業中，臨床試驗服務業(CRO)為收益最佳且最具發展價值的項目，2009年全球CRO總營收中，臨床試驗服務業營收就約占總營收的一半，加上近來全球各國開始加速醫藥產業的發展，國際藥廠也逐漸加重臨床試驗外包比例，整體全球臨床試驗服務產業需求大增。 台灣自1997年起，本土企業就開始努力耕耘於臨床試驗服務領域，直至今日，已累積許多成功的經驗與案例，然而在面對國際大廠寡占市場，以及亞洲新興國家CRO企業如雨後春筍般盛出的環境下，台灣CRO企業於發展上仍飽受壓力，不過，這些在多年的經營下，事實上也已累積了相當的能力，若能針對自身核心能耐進行統整分析、經營及拓展，相信仍將有辦法面對全球之競爭環境。此外，由於臨床試驗服務業屬知識密集之服務性產業，經驗累積、專業性及外部關係資產等智慧資本皆較有形資本更能代表企業所具之價值，因此，本研究主要從智慧資本的角度來探討臨床試驗服務企業所具有之核心能耐，並依不同經營時期比較核心能耐之變化，以了解企業所具有之競爭優勢及優勢變化。一方面期望透過本論文之架構，提供企業有關自身核心能耐之分析方式的參考，協助其進行自我核心能耐之統整分析，另一方面，也期望藉由本論文之CRO企業核心能耐之個案分析，提供企業在選擇經營或拓展核心能耐時作為參考。 本研究所得到的結論如下： 1. 運用外部關係資本-與其他企業進行聯盟合作，是臨床試驗服務公司用以提升服務能力、擴大服務範圍，及拓展核心能耐的重要方式。 2. 臨床試驗服務公司所具明確的企業價值與文化，有助於其營運上的發展以及獨有特色的創造。 3. 發展較成熟的臨床試驗服務公司會具備涵蓋人力資本、組織結構資本及顧客關係資本之核心能耐，所具備之核心能耐較不易再進行拓展，反之，較新進的臨床試驗服務公司則較易拓展其核心能耐。 4. 臨床試驗服務公司所擁有的「教育」及「品牌」智慧資本，有助於提升公司其他的智慧資本。 5. 我國本土臨床試驗服務公司較重視發展具差異性之核心能耐，而我國外商臨床試驗服務公司則較重視員工專案執行之能力。 關鍵詞：臨床試驗服務產業、CRO、核心能耐、智慧資本 / In the Bio-service Industry, clinical trial service is the most profitable and valuable item. In 2009, the revenue of clinical trial service accounted for about half of the revenue of CRO Industry. Recently, since all the countries in the world are speeding up developing Pharmaceutical Industry and pharmaceutical companies are gradually raising the proportion of clinical trial outsourcing, the demand of clinical trial service are grately increasing. From 1997, Taiwan local companies have been working so hard in the clinical trial service area. Till now, Taiwan local companies have accumulated lots of successful experience. But when facing the oligopoly market of CRO Industry and competition of Asia new CRO companies, Taiwan CRO companies still have big stress on operation. However, since Taiwan CRO companies have had great competence in clinical trial service, we believe that if Taiwan CRO companies can tidy up, analyze and expand their own core competence, the competitive strength of Taiwan CRO companies will get improved to face the global competition. Besides, intellectual capital of CRO companies which are knowledge intensive business services (KIBS) shows real value of the CRO companies. Hence, this study is trying to investigate the core competence of clinical trial service companies from intellectual capital aspect, and also trying to compare the differences of the core competence in the different timing. We hope this study can on the one hand provide CRO companies a way to analyze their core competence, and on the other hand can provide the successful core competence information of the study cases for CRO companies as a reference. There are several conclusions from this study: 1. Using relationship capital-business collaboration is an important way for the clinical trial service companies to improve their service ability, broaden their service area, and develop their core competence. 2. The clear values and culture of clinical trial service companies can help the development and operation of the companies, and create the characteristic of the companies. 3. A mature clinical trial service company has accumulated plentiful core competence in human capital, organizational capital and customer capital, and it’s hard for the company to deepen and broaden its core competence. Relatively, it’s easier for a young clinical trial service company to develop its core competence. 4. The intellectual capital of “Education” and “Brands” of clinical trial service companies can upgrade other intellectual capital of the companies. 5. Taiwan local clinical trial service companies emphasize the core competence with differenciation while foreign clinical trial service companies in Taiwan emphasize good executive ability of the employee. Keywords: Clinical trial services, CRO, Core competence, Intellectual capital