由於全球環境競爭激烈，使研發服務業在產業中所扮演的角色越趨重要，為對該產業的前景有更清楚的了解，本研究以研發服務業的未來發展策略為題，對其作深入的探討。 本研究先分析整個大環境為研發服務產業所帶來的機會與威脅，完善的國家基礎設施、放寬融資管道限制、B-B電子商務商機無限、系統整合需求大幅提升，為該產業提供了許多機會；再從內在分析來看，由於研發服務產業競爭者眾，為求與同業形成差異化，擁有專精的產品研發能力與全面性的服務已不可或缺。 研究結果發現國內研發服務業的關鍵成功因素為:大型專案之標價競爭能力、具備專業知識、新產品與技術之研發與開發能力、多元化的資訊軟體與硬體技術、與上游軟體與硬體供應商良好關係等。 本研究從公司使命與目標著手，設定公司未來發展方向，並訂定根本策略、競爭策略和營運策略： 1.個案公司根本策略最適合採取成長策略，才能發揮個案公司的核心能力，尤其是應該在短期對國內市場採行產品擴張策略，在中長期對國外市場採取地理擴張策略。 2.個案公司的競爭策略為差異化，個案公司擁有多樣化產品及服務、專業技術團隊、豐富的相關經驗、擅長開拓業務的人員等，透過這些優勢，個案公司可以建立產品差異化。 3.對個案公司內外在分析、擬定根本策略及競爭策略之後，進而對個案公司擬定相關的營運策略包括行銷策略、財務策略、人力資源策略、組織策略以及控制策略等。

自二十世紀末起，隨著寬頻網路科技的興起，人類經濟社會出現了大幅度的改變，生產要素可以迅速在全球各地組合，一般稱此為全球化現象。而在全球化的競爭環境中，只有內隱於個人或企業的知識是難以取代而最具以差異化的特性的，因此進入二十一世紀，企業莫不視知識為最重要的生產要素，此種情況就是一般常說的知識經濟。 本研究欲探究的問題就在於，處於知識經濟時代的台灣要如何強化競爭力？就企業而言，知識的累積要靠研發，則企業要怎樣提昇研發能力呢？這個問題可能有許多方面可以切入，但本研究感興趣的是基於專業分工以創造最大效益的想法，除了靠企業自己研發之外，若是有強有力的周邊研發服務產業之支援，應當對企業之研發能力提昇有加乘效果。至於要怎樣提昇我國研發服務業之發展，本文則提出一些初步的看法。不過需提醒者係，本文的研究取向是偏重總體面的研究，重點在站在政府與國家的立場，探討台灣整體研發服務業之發展問題，至於個別研發服務產業的競爭策略，則非本文之重點。最後，本研究展開的架構，除了第一章交代研究之方法、架構與文獻介紹外，基本上乃依據以下章節安排，順序討論： 首先，在第二章中本章，透過幾個本論文中使用的關鍵字辭之解釋，將本論文之基礎理論做一初步介紹。本文以為面對知識經濟之外在環境挑戰，台灣應以強化包含研發服務業在內之高附加價值知識型服務業作為回應，而此不僅可使產業升級，更可強化台灣的國家競爭優勢。究其實，本文以為研發服務業之興起其實是產業不斷分工下所必然，其經濟上理由在於降低交易成本。 接者在第三章中，本文進一步對我國目前的研發服務業狀況做一簡短介紹，整理出一些數字，並具體指出我國目前發展研發服務業所面臨之問題。此外，本章並分別引介兩個國家發展研發服務業之情形，一個是世界上研發活動最興盛的美國。本文發現美國成功的原因在於政府放任的態度，與大學和產業界的密切結合;另一個則是我國的主要競爭對手—韓國，本文發現韓國主要利用租稅優惠作為政策手段。比照此二國家的狀況，本文以為特別值得參考他們對人才的重視、強調大學的角色以及利用租稅作為政策工作之做法。 從第四章開始，本論文開始試著提出一些發展我國研發服務業的方法。第四章是站在產業面的角度，指出目前台灣發展研發服務業所面臨的瓶頸。而針對當前的處境，本章試著回答一個問題: 如果要發展研發服務業政府到底應該做些什麼?本章對此，提出了五個方向:第一，產業發展需要方向，且台灣長期經濟發展都是政府引領而民間參與的方式下進行，則本文以為政府應針對個別產業部門而致力於提出一套符合個別產業需求的國際化科技政策。本文並指出我國未來科技產業重點應放在基礎科學研究的植根。第二，「成事在人」，政府應積極協助培育產業界需要的國際化人力。第三，「巧婦難為無米之炊」，政府應致力於協助企業吸引國際化的資金，使台灣成為亞太籌資中心。第四，要重新塑造大學的角色，使大學與產業界緊密合作。第五，本文以為資訊科技業屬於研發服務業中的重點產業，政府應該大力推展，本文並提出其原因與可能的發展方向。 第五章則本文從法律面出發，探討如何透過法律制度與法律服務業的健全以形塑我國良好的投資與研發環境。首先，本文主張政府應以揚棄家父主義的思維，而改以負面表列的態度，進一步對服務業解除管制，以釋放民間活力。具體來說，本文認為政府應該做到以下幾點：公平的稅制與適度的優惠措施間應取得平衡、放寬組織上的法令規範、創新使智慧資等得以入賬之會計法令、人事法令制度鬆綁與建立方便商業(特別是科技業)糾紛解決之司法制度。其次，本文認為良好專利制度對企業研發幫助至大，而我國在專利制度上則尚有諸多有待改進之處，包含：專利審查品質有待提升、專利資訊網路化有待加強與類似美國ITC的保護制度有待建立。最後，面對台商的出走，台灣法律服務業並無法提供所需的境外服務。本文以為要健全我國的法律服務，在制度面應從放寬組織法上的限制著手，賦予律師事務所法人化的法源依據，使我國律師事務所能成長到一定之規模並永續經營。 第六章則是結論，本文以表列的方式，把本文的初步看法整理出來，以為台灣未來發展研發服務業的策略建議。 / This is a thesis discuss how to strengthen the R&D ability by the support of R&D service industry. Since the late 20th century, Broadband technologies had developed rapidly, which led human economic society to a whole new world. Today, factors of production can be purchased and matched anywhere around the world. It is called the GLOBALIZATION. In the global competitive environment, only the knowledge which is hidden in the brains of people or the memories of organizations cannot be replaced, so only can the knowledge make the differentiation. Therefore, all industries consider knowledge as the most important factor of production in the 21st century. It is what we call the KNOWLEDGE-BASED ECONOMY. I am trying to answer a question---how to enhance Taiwan’s competitiveness in the era of knowledge-based economy? Moreover, we know that the creation as well as accumulation of knowledge for the industries depends on R&D. Then, I want to further realize how the industries can strengthen their R&D abilities. Of course, there are many approaches to state the issues, but this I will only focus on the idea of maximization of efficiency by the division of labor. I believe if there are many well-developed Industrial Technology Oriented Service to support the R&D for the manufacturing industries, it will be have effect of synergy that will make Taiwan’s R&D environment better. However, I have to remind my readers that I will illustrate the issues by the macroeconomic approach, so I will discuss how to develop and promote whole industrial technology oriented service from the standpoint of Taiwan’s government. I will rarely discuss how an industrial technology oriented service company competes, only necessary. Finally, let me induce my thesis’ structures below: Chapter 1: I discuss my research approaches and how I organize my thesis. In addition, I do a brief review about the early research on this issue. Chapter 2: I explain my basic ideas by the definition of some keywords in the thesis. My basic ideas are that Taiwan should develop highly value-added industries, such as industrial technology oriented service to respond the challenge of knowledge-based economy, because it will make whole industry upgrade and improve Taiwan’s competitiveness. In summary, I believe that industrial technology oriented service will grow because of division of labor, and the economic reason is to cost down. Chapter 3: I do a brief industrial analysis of Taiwan’s industrial technology oriented service in this chapter. I collect some tables and figures, and I point out the problems that now hinder the development of Taiwan’s industrial technology oriented service. On the other hands, I introduce how other countries to promote industrial technology oriented service. Firstly, I discuss the situations of USA, the country best at R&D in this world, and I find that American universities have tight relations with industries. Secondly, I analyze the situations of South Korea, the Taiwan’s main competitor, and I find that Korean government mainly relies on the tax subsidies to promote their industries. Chapter 4: I point out the bottlenecks for the promotion of Taiwan’s industrial technology oriented service from the perspective of business in this chapter. Then I try to bring up some ideas on how to promote Taiwan’s industrial technology oriented service, and I think there are five business mechanisms that are of crucial importance to achieve that goal. Firstly, in general, Taiwan’s industrial developments are by the way that government directs private sectors. Therefore, industries have used to depend upon government in Taiwan. In the future, I think government should design different global competitive policies for each industrial sector. In addition, Government should endeavor to promote fundamental science research. Secondly, I think government should foster international human resources. Thirdly, capital is still an important factor of production, especially for high-tech industries, so I believe that government should help industries raise funds easily in Taiwan by building up Taiwan to be the Asian fund-raising center. Fourthly, the role of university should evolve. University is part of National Systems of Innovation. University should not only do teaching and research, but also have responsibility to promote economic development. Finally, I believe we have entered into the age of information. Consequently, I think information technology industry will be the key industry of Taiwan’s industrial technology oriented service, and government should especially focus on this industry to promote. Chapter 5: In this chapter, I change the angle from business to legal system to discuss how to promote Taiwan’s industrial technology oriented service by law. Firstly, it is my advice that government should abandon the ideology that she is the guardian of her people. Then government should recognize that people can do anything which is not forbidden by law without prior approval, and government should release the restriction and provoke the social vitality by deregulation. More specifically speaking, I think there are some things worth government’s effort, such as the balance of fair tax system and the subsidy, relaxing the restrictions on corporate organization, especially on law firm, the innovation of accounting code to make intellectual capital in the account book, the reform for civilian systems as well as legal procedures that are suitable for business dispute resolution. Secondly, I feel that Taiwan’s government should continue the reform of patent system. My suggestions are that government should improve the quality of patent examination, build up a strong searching engine for patent information, and try to learn something from USA’s ITC 337 rule. Finally, manufacturing industries moving out is a big issue for Taiwan. I believe it’s an inevitable trend. However, Taiwan’s legal service lacks ability to support Taiwan’s company globally. My opinion is that government should approve lawyers to found corporations that will make law firms grow and eventually can increase the competitiveness and competence of Taiwan’s law firms. Chapter 6: This chapter is the conclusions. I tabulate my opinions, and I think that those opinions may be helpful for Taiwan’s government to choose the strategies to promote Taiwan’s industrial technology oriented service.

昂貴的藥物研發成本，促使製藥生技產業的委外營運模式，以合約方式提供在藥物研發過程中專業化服務的產業，而近年來由於委外研發服務的高效率，已明顯縮短了新藥開發的時程；同時，在全球醫藥研發服務產業的市場中，約有超過七成的收益來自於臨床試驗服務；由此顯見醫藥研發服務產業中的臨床試驗部分的重要性。 醫藥研發服務是個高度國際性競爭的產業，如何找到發展的核心利基以突破重圍，是許多後進企業或國家所必需面對的嚴峻考驗。因此，本研究主要描述台灣目前的醫藥研發服務產業以及臨床試驗產業發展概況，並探討台灣是否具備發展臨床試驗產業的實力。透過本研究，希望對於台灣發展臨床試驗產業，或是推動台灣成為亞太臨床試驗中心，都能提供作為規劃與執行時的參考資訊。 本研究重要結論與建議如下： 1. 以新藥研發價值鏈而言，台灣目前在每一個階段的工作均已佈局，其中又以臨床試驗階段最有潛力加入國際的競爭市場；長期而言，為追求醫藥產業最大的經濟效益，應強化國內的基礎研發工作，進而刺激與培養國內醫藥研發服務產業的能量。 2. 產業政策的落實不能只談邏輯架構或觀念，應該設定明確的推動方案、目標與達成時間表，要推動產業必須貫徹以管理的觀念；同時也應加速業者與官方之間的溝通協調，其中包括藥政主管單位對於產業發展應由被動轉為積極主動的角色，另外，政府部門跨部會的整合也是相當重要的。 3. 國內的全民健保制度涵蓋了所有醫療資源的運用，而健保制度的設計缺乏鼓勵預防與醫藥研發的投入的機制。因此建議應深入分析與探討健保對於產業的影響，進而能以更積極正面的態度促進製藥生技或醫藥研發服務產業的發展。 4. 建議國內可以由政府與製藥產業界共同出資，成立具有公信力且目標明確的教育訓練組織，提供以實務為導向且有系統的在職教育，用以規劃與培植國家未來所需要的專業臨床試驗人才。 5. 建議國內應就醫療院所執行臨床試驗相關作業訂定管理原則，包括臨床試驗贊助款的管理與運用規範、相關執行人員的權利義務等，藉由透明化的標準與明確的獎勵制度，提高醫師與醫院參與臨床試驗的動機；同時也應鼓勵醫院設立專責的臨床試驗辦公室，執行各項協調、整合與管理的工作，並促進與產業界間的互動。 / The cost of drug research and development has soared during the past years. And this compels pharmaceutical and biotechnology companies to look for new, smarter ways of running their businesses. One of their strategies is trying to accelerate drug development by outsourcing. The size of the outsourcing market for Contract Research Organizations (CROs) is rising. Clinical-trial operations hold over 70% of the revenue in the CRO industry. Competition in the CRO industry is extremely international in scope. The key issues for the catching-up company or country is to find their own niche. This study goes on to identify and profile the development of clinical trials and the CRO industry in Taiwan. It also seeks to identify ways of showcasing Taiwan as an Asia-Pacific Clinical Trail Service Center. There are several conclusions from this study: 1. In the value chain of new drug discovery and development, the current status in Taiwan has the potential to join the international market by conducting the clinical trials. In the long term, we should consolidate our basic medical research to pursue the maximum benefit of biotechnology and pharmaceutical industry, and then to enhance the capability of CRO in Taiwan. 2. The policy for improving industry must be set up after the explicit acting plans, goals and time schedule. It should go through with management, not just a structure or concept. We have to hasten the communication between industry and government. The medical legal authorities need to be more active. Ultimate integration of the functions of the related government departments is exceedingly important. 3. The National Health Insurance (NHI) system covers all of the medical resources in Taiwan, but it lack for the incentive to encourage the medical research. It is recommended that NHI Program should probe into the impact of the biotechnology and pharmaceutical industry, and then try to revise it with more positive thinking. 4. It is very important for Taiwan to improve the professional in clinical trials. Setting up a training center funded by both government and industries is strongly recommended. The organization will have the definite goals and accountability, and provide practical training and systematic continuing education. 5. We need more regulating operations of clinical trials of hospitals in Taiwan. These operations should include the usage of the fees from sponsors, and the rights and responsibilities of all staff. We should set up a transparent standard and obviously encourage a mechanism to enhance the motivation of physicians and hospitals to participate in clinical trials. Hospitals should be encouraged to establish an independent office for clinical trials to perform all the details. This office will promote the interaction within the industries.