Currently, there are the following challenges in clinical trials:

● The complexity of clinical trial protocols and the resulting non-compliance

● The contradiction between the explosive increase in the number of clinical trials and resources

● Imperfect quality control system and poor process compliance

Centralized monitoring, as a part of risk-based monitoring, can serve as an important supplement to on-site monitoring and has the following advantages:

● Utilize centralized remote monitoring methods to reduce workload/cost savings

● Identify problems early, focus on problem-solving, and prevent their recurrence

● Focus on the core data and core programs of the project

● Ensure compliance with the trial protocol, GCP, and regulations.

● Able to deepen collaboration among multiple functional departments, including CTM, CRA, DM, statistics, medical monitoring, and testing center members. Breaking away from the previous situation of individual combat and lack of communication, project management has become more efficient, and control over the quality of experiments has been strengthened.

Centralized monitoring service:

● Participate in risk assessment

● Participate in defining core data and core programs

● Participate in creating quality and risk management plans

● Create a centralized monitoring plan

● Periodically provide centralized monitoring lists/tier profiles

● Assess risks and participate in KAPA development