**1. Introduction**

According to the 2020 biotechnology industry white paper, the global pharmaceutical market in 2019 reached approximately US \$1.25 trillion, an increase of 4% compared to 2018. It takes an average of 10–15 years and the US \$300–800 million to develop a new drug. Under increasingly strict global supervision, drug development has become more complicated, requiring numerous resources and equipment support. Therefore, reducing development and time costs, and ensuring compliance with strict regulations and standards at the same time, has become a common problem faced by global biotechnology and pharmaceutical companies.

In the entire drug development process, the clinical trial phase requires one-half to two-thirds of the development cost and time. Due to this, clinical trials have been outsourced to the Contract Research Organization (CRO) in recent years. According to Frost & Sullivan estimates, the global CRO turnover in 2019 reached

approximately US \$49.74 billion, an increase of 8.5% compared to 2018. It can be seen that the clinical trial service industry is very important for biotechnology and medicine. Furthermore, the CRO industry is a knowledge-intensive industry. Professional knowledge and skills are its main requirements, which are also key to the competitiveness of enterprises. Additionally, the accumulation of experience and knowledge, and the maintenance of external relations are both important assets for an enterprise in the clinical trial industry. Therefore, improving the competitiveness of an organization through effective knowledge management has become one of the most important issues in business management.

Previous research on CRO mainly focused on its strategy, business, and operations model, and seldom discussed the knowledge management of CRO. Therefore, this research will focus on the CRO industry and select companies that provide clinical trial services in Taiwan to study their knowledge management practices and the impact of influencing factors on knowledge management activities.

The issues to be discussed in this research are as follows:


In the following section, an overview of the CRO industry is introduced, as well as related literature on influential factors of knowledge management and knowledge management activities. The research framework is then introduced in the third section based on the research purpose and the literature review results. Besides, in this section, the research method, research objects, and data collection methods of this study are further explained. The fourth section describes the research cases. In the fifth section, seven research propositions are proposed and are followed by discussions. Finally, conclusions are drawn and the theoretical implications are depicted in the last section.
