我國臨床研究委託機構（CRO）的知識管理活動與知識管理影響因素之探討

Exploring Knowledge Management Activities and Influential Factors of Contract Research Organizations (CRO) in Taiwan

葉宜芝(Yeh Yi-Chih)

指導教授 ： 吳豐祥

國立政治大學/商學院/科技管理與智慧財產研究所/碩士(2021年)

https://doi.org/10.6814/NCCU202100721

摘要

研發一顆藥物平均需耗費10-15年的時間，與100-200億台幣的金錢成本，加上全球監管日趨嚴格下，藥物開發顯得更加複雜且困難，特別是中間過程需要冗長的、花費龐大的臨床試驗。而對藥廠來說，大部分是沒有執行臨床試驗的能力，因而，需要專業的臨床研究委託機構（CRO）來協助。根據Frost & Sullivan推估，2019年全球CRO營業額約達497.4億美元，較2018年成長8.5%，由此可見，製藥廠將臨床試驗委外的需求不斷上升，使得CRO在生技醫藥產業占有舉足輕重的地位。而以往有關CRO的論文研究中，較多針對其策略面、業務及營運模式等作探討，鮮少著重於知識管理面向。所以就知識密集型的CRO產業來說，因而存在著重要的研究缺口，因此，本研究以CRO產業為主軸，選定我國提供臨床研究委託服務之機構，探討其知識管理的作為。

本研究依據研究目的，先進行相關文獻的探討，接著，提出一個「整合性」的研究架構，包含「知識管理影響因素」與「知識管理活動」兩大領域，其中前者包括「策略與領導」、「組織文化」、「人員因素」、與「資訊技術」等四個構面。後者則包括「知識創造與吸收」、「知識蓄積與儲存」、「知識擴散與交流」、與「知識保護」等四構面，並以此架構為基礎來探討我國CRO在協助製藥公司進行臨床試驗之「執行」階段時的知識管理作為。研究方法上採用多重個案研究法，並選擇四家我國提供CRO服務之機構進行深入的個案研究，探討其知識管理影響因素與知識管理活動之關聯。

本研究所得到的結論如下：
1.我國CRO在進行知識管理時，若是其知識管理的概念與組織成員日常工作標準程序的結合程度越高，則其知識蓄積與儲存活動及知識保護活動也越容易執行。
2.我國CRO在進行知識管理時，於知識擴散與交流上，會強調經驗分享的文化與資訊技術的運用。
3.我國CRO在進行知識管理時，於知識擴散與交流及知識蓄積與儲存上，會強調領導階層的支持與完善人力資源管理系統的配合。
4.我國CRO在進行知識管理時，會以其內部SOP、臨床試驗計畫書、相關學術文獻，以及外部研討會的參與等，做為其組織成員重要的內、外部知識吸收來源。

本論文研究最後並提出學術上與實務上的意涵，同時對後續的研究提出相關建議。

關鍵字

知識管理 ； 知識管理影響因素 ； 知識管理活動 ； 臨床研究委託服務機構 ； 知識密集型產業

並列摘要

Developing a new prescription medicine takes 10-15 years and costs drugmakers NT$10-20 billion on average. Under strict supervision, it is brutally difficult for a drug to be approved for marketing; especially the highly expensive, time-consuming clinical trials. Hence most pharmaceutical companies need the support of Contract Research Organization (CRO) to conduct clinical studies. According to Frost & Sullivan, the global CRO market in 2019 is approximately US$49.74 billion, with an 8.5% growth compared to 2018.

This shows that the demand for clinical trials outsourcing has become increasingly common in the pharmaceutical industry. That is where the CRO play a pivotal role. The previous studies have focused largely on aspects of business strategy, operation and business model of CRO. Given that CRO is a knowledge-intensive industry, the lack of research in knowledge management has led to a serious research gap. Thus, our study explores the knowledge management practices of institutions that provide CRO services in Taiwan. We adopted an integrated research framework, including two main views; knowledge management influential factors and knowledge management activities. The first view includes “Strategy and Leadership,” “Organizational Culture,” “People” and “Informational Technology.” The second view includes “Knowledge Creation and Absorption,” “Knowledge Accumulation and Storage,” “Knowledge Diffusion and Exchange," and “Knowledge Protection.” Based on this framework, we investigated the knowledge management practices during the “execution” phase of clinical trials of CRO in Taiwan. The employed research methodology is multiple case studies. We selected four institutions that provide CRO services in Taiwan to demonstrate the relationship between knowledge management influential factors and knowledge management activities.

Conclusions drawn from this study:
1. When implementing knowledge management, the more the concept of knowledge management is integrated with the standard operating procedures, the easier it is to carry out knowledge accumulation and storage and knowledge protection activities for CRO in Taiwan..
2. When implementing knowledge management, CRO in Taiwan emphasized the importance of shared experience and the application of information technology on knowledge diffusion and knowledge exchange.
3. When implementing knowledge management, CRO in Taiwan emphasized the coordination between the support from executives and integration of the human resource management system on knowledge diffusion and exchange, and knowledge accumulation and storage.
4. When implementing knowledge management, CRO in Taiwan considered internal SOP, clinical trial protocol, relevant academic literature, and participation in public seminars as important sources of internal and external knowledge absorption.

The final section of our study provided the theoretical and practical implications, and proposed suggestions for future researchers to carry out.

並列關鍵字

Knowledge Management ； Knowledge Management Influential Factors ； Knowledge Management Activities ； CRO ； Knowledge-Intensive Industry

參考文獻

英文文獻

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