**Case illustration:**

The standard of procedures (SOP) of IQVIA includes some rules of knowledge management practices that employees have to follow. In addition, the company assigns specific staff for designing corresponding training programs and continuously adjusts the rules. PRA not only integrates knowledge management practice requirements into SOP, but also into general clinical practice (GCP), particularly in the areas of knowledge accumulation and protection. They also pay attention to whether employees comply with the regulations. Both FBTC and A2HC integrate the rules of knowledge management accumulation and protection into their training programs and SOPs. In FBTC, the quality assurance (QA) personnel are in charge of the monitoring process, in A2HC, both QA and the heads of divisions are responsible for checking KM implementation.

### **Discussion:**

For the CROs, the accumulation and protection of clinical trial knowledge and results are critical information and are important documents to conduct further analysis and for later authority checks. It is believed that once the rules and processes of knowledge management can be integrated into the SOP, training programs, and daily working life, the concept and importance of knowledge management can be better realized by employees. Thus, a higher performance by CRO firms is expected. Although a few studies have tried to connect knowledge management with operations management, such as [18], very few have addressed how the knowledge management practices are transformed into the SOP.

### **Proposition 2:**

**When CROs implement knowledge management, they tend to emphasize the organizational culture of knowledge sharing to stimulate effective learning and inheritance of experiences among employees.**

### **Case illustration:**

Both IQVIA and PRA have an obvious knowledge-sharing atmosphere. They organize different groups from different divisions, with group heads in charge of promoting knowledge sharing. These heads monitor the situations of colleagues implementing knowledge management and suggest a change in KM rules to their supervisors when necessary. FBTC and A2HC emphasize knowledge sharing in formal meetings, through which a few cases are discussed. The latter firm also relies heavily on its internal intranet for knowledge sharing, learning, and recording.

### **Discussion:**

A large amount of tacit knowledge exists in the brains of individual employees. This knowledge can be shared with others, and can create values for the organization [9, 19]. Thus, the degree of employees' willingness to share their knowledge and experiences, usually determined by the organizational culture, is a key factor in knowledge sharing. As for the CROs, many projects are quite similar with only differences in external partners and contractors that may require different working methods. Therefore, if employees working for different groups can share knowledge and techniques with one another, they can improve their knowledge base, capabilities, and work efficiency.

### **Proposition 3:**
