With the rising of R&D outsourcing, Contract Research Organization (CRO) are increasingly given emphasis and recognition of pharmacy and developing as an indispensable link of pharmaceutical industry chain owing to it's professional superiority. Firstly, the development and current status of domestic and overseas CRO were introduced. Subsequently, the potential demands of Chinese medicine (CM) industry to CRO were analyzed. At last, enhancing new drug R&D ability and changing the low level repeat status of CM industry in virtue of CRO were indicated. Several problems were found in my research, involving (1) Although there're lots of CROs in China, most of them are just starting up and focusing on clinical trials while not R&D of CM; (2) CROs or corresponding branches in overseas have robust R&D networks and management systems, however they cannot supply the R&D service of CM in a short period; (3) Since a long period of time, the majority of R&D resources in China were possessed by universities and research institutions, which undertook the primary R&D works of CM and exerted the analogous functions to CRO. On that basis, a conclusion was drawn that at present CRO is not the best mode in China and it is necessary to explore a new CRO mode in R&D of CM area integrating the facts and status quo. Virtual research organization has been widely applied in many research fields with shared resources and complementary predominance. Some experts in medical area brought forward a concept i.e. Virtual Contract Research Organization (VCRO) combined virtual research organization with CRO. In this thesis, we introduced this concept into CM area and indicated to stimulate the development of CM industry by establishing VCRO of CM and analyzed the necessity and feasibility. On that basis, the key links of establishing VCRO of CM and project management methods of new drug R&D were deeply explored. In transverse direction, the construction methods of VCRO in CM area were generalized and a set of evaluation index system of choosing cooperative partners was set up through expert consultation to evaluate the R&D ability and strength of partners in VCRO and offer references for final selection. Secondly, the institutional framework and profit sharing mechanism of VCRO of CM were studied. Finally, the maneuverability and superiority of VCRO in a practical world were proved by case analyzing of "Debio mode". In longitudinal direction, aiming at the characteristics of VCRO management and CM R&D, the project managements of new drug R&D of CM based on VCRO were discussed according to the project flow of startup, plan, execution, control and ending. We have achieved research works encircling tightly the theme of "VCRO of CM" in this thesis and expected to promote the development of CM industry via this new organization mode. Key words: R&D of CM; Virtual Contract Research Organization (VCRO); project management

隨著研發外包熱潮的興起,合同研究組織(CRO, Contract Research Organization)以其專業化優勢逐漸得到了制藥界的重視和認可,並迅速發展成 為制藥鏈上不可缺少的一個環節。本文首先介紹了國內外 CRO的發展和現狀, 緊接著分析了中藥產業對CRO的潛在需求,但是,也存在幾個問題:(1)我國 的CRO 雖然數目較多,但大多數發展還不成熟,內容也主要集中在臨床試驗階 段,而且較少有針對中藥研發的 CRO;(2)國外的CRO 或分支機構雖然有著 比較健全的研發網絡和管理系統,但短期內並不具備提供中藥研發服務的能 力;(3)長期以來,我國的大多數研發資源主要分佈在高校和科研院所,它們 承擔了主要的中藥新藥研發工作,發揮著類似於 CRO的職能。在此基礎上得 出結論:在我國合同研究組織目前並不是最佳模式,要結合實情和現狀,探討 針對中藥研發的合同研究組織新模式。 虛擬研發組織廣泛應用於各大研究領域中,具有“资源共享、優勢互補” 等優勢,一些醫藥領域的專家將虛擬研發組織與 CRO 結合,提出了虛擬合同研 究組織(VCRO, Virtual Contract Research Organization),本文將這一概念引入中 藥領域,提出應該建立中藥虛擬合同研究組織來促進中藥產業發展,並進行了 必要性和可行性的論證。在此基礎上,著重對中藥虛擬合同研究組織建立的重 點環節和新藥研發項目管理進行了深入探討。橫向上首先概括了中藥虛擬合同 研究組織的建立方法,通過專家諮詢法建立了一套合作夥伴選擇的評價指標體 系,用來對擬合作夥伴的研發能力和實力進行評估,為最終選擇提供參考;其 次通過文獻分析,探討了中藥虛擬合同研究組織的組織結構和利益分配機制; 最後通過“德彪模式”的案例分析,來證明虛擬合同研究組織在現實中的可操 作性和優越性。縱向上針對虛擬合同研究組織管理的特點和中藥研發的特點, 按項目啟動、項目計畫、項目執行、項目控制和項目收尾的流程探討了基於 擬合同研究組織的中藥新藥研發項目管理。 本課題緊密圍繞“中藥虛擬合同研究組織”這一主題展開研究,以期通過 這一新的組織模式推動中藥產業發展。 關鍵詞:中藥研發;虛擬合同研究組織(VCRO);項目管理