**Abstract**

The pharmaceutical industry is critical to a nation's economic development and welfare. However, most pharmaceutical companies do not have the capabilities to complete clinical trials by themselves and need assistance from the contract/clinical research organization (CRO). Clinical trials are highly knowledge-intensive and include several fields, such as toxicology, statistics, production, biology, health care, pharmacology, trial protocol design, and legal regulation. In academic research, few studies have focused on studying this important area from the perspective of knowledge management. Consequently, this research aims to fill this research gap by investigating knowledge management activities and influencing factors of CRO. A holistic framework was designed for this research, with the former (knowledge management activities) including four major constructs: knowledge creation and absorption, knowledge accumulation and storage, knowledge flow and diffusion, and knowledge protection, and the latter (influencing factors) including strategy and leadership, organizational culture, people, and information technology. Four CROs in Taiwan were selected for in-depth case studies. The research results are expected to contribute to both academia and industry.

**Keywords:** knowledge management, knowledge management activities, key influential factors, Contract Research Organization, clinical trial, CRO
