Clinical operations:

It refers to a series of activities of clinical trials in the process of drug development, including trial design, site selection, monitoring, data management and reporting, etc. The main objective of clinical operations is to ensure the smooth progress of clinical trials and generate high-quality data to support the safety and effectiveness of drugs.

• Feasibility assessment: Clinical trial feasibility assessment, center/researcher identification, center feasibility assessment, and qualification review.

• Clinical strategy: Clinical trial planning and implementation, risk identification and management.

• Project management: Project team coordination and communication, clinical trial training, GCP training, stage progress report, third-party management and quality control.

• Clinical monitoring: IEC/IRB submission of data, Human Genetic Resources Administration (HGRAC) declaration, center start-up, researcher conference planning and implementation, investigational product (IP) management and supply management, serious adverse event (SAE) management, and query answer.