Based on the latest medical knowledge, we review clinical trial protocols to assess whether the purpose of the clinical trial clearly address the unmet medical needs within the relevant disease area, and whether the proposed study design is the most scientifically efficient and effective approach to achieve those objectives. Through this consultation, we ensure the scientific robustness and ethical appropriateness of the clinical trial, thereby enhancing the reliability of future research outcomes.

We conduct medical evaluations of all Adverse Events (AEs) and Serious Adverse Events (SAEs) that occur during clinical trials. Leveraging medical expertise, we perform in-depth analyses to determine the causal relationship between each adverse event and the investigational drug. When necessary, we provide medical recommendations for protocol modifications.

In addition, we comply with regulatory requirements regarding when and how to report adverse events to the relevant authorities, ensuring that all safety information is accurately and promptly communicated. We establish a clear safety profile of the investigational drugs, ultimately playing a vital role in meeting the ethical and scientific standards essential for new drug development.

To maximize the scientific validity of clinical trials and clearly establish clinical utility, we apply the latest medical knowledge throughout the entire clinical trial lifecycle. We play a key role in deeply interpreting and analyzing collected data from a medical perspective. This includes continuous analysis and integration of the latest literature, international conference trends, updated regulatory guidelines, and relevant clinical research outcomes related to specific disease area and therapeutic class. From the clinical trial protocol design stage through to the selection of evaluation variables, patient population definitions, and statistical analysis plan development, we support the establishment of optimal scientific strategies.