For medical affairs, 3 medical specialists provide advices on what need to be considered from medical point of view during the phase of establishing strategies and plans for developing new drugs and technologies. They suggest and review the target patient population, study design, and evaluation variables during the preparatory phase for clinical trials in parallel with providing answers to medical inquiries and evaluating safety during each study period.
LSK Global PS provides consultation on the following issues that must be medically taken into consideration in establishing the strategies and plans
Study physicians carry out their roles in providing medical consultations required for a clinical program and individual clinical studies to produce accurate results from and enhance the values of clinical studies. They also resolve the inquiries requiring medical decisions during the course of clinical studies, communicating with investigators or research team.
Medical monitors evaluate the relationship of medical inquiries and adverse events arising during the study with an investigational product based upon the protocol and also conduct monitoring of the measures and follow-ups according to the severities of adverse events.
For success in the clinical development, the members who conduct this need to understand the new drug or technology and its target disease(s), and LSK Global PS provides them with the training for conducting clinical trials on it.