Medical Service

Medical Service

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.

Medical Consulting

LSK Global PS provides consultation on the following issues that must be medically taken into consideration in establishing the strategies and plans

1) Target Product Profile (TPP) of New Drug and Technology
A target product profile is the aim of developing a new drug taking its labeling after launch into consideration from the early phase of development. It outlines the strategies and plans based upon how to demonstrate; the aim of developing the target indication(s), the efficacy and side effects of a target product in non-clinical and clinical studies, and the values and marketability of a developed product compared to the existing treatments, competitive drugs or technologies through the results from such studies as well as the regulatory rules and regulations of individual countries.
2) Strategies and Plans for Clinical Development
Based upon the TPP, LSK Global PS designs and plans the entire process of clinical development considering the target goal at each development phase, scales of clinical trials required by country, development statuses of competitive drugs or technologies, milestones for development, etc.
3) Clinical Trial Designing
LSK Global PS makes detailed plans for the essential matters at each phase of conducting clinical trials including the patient population most suitable for target indications, comparator group, treatment period, efficacy and safety endpoints, and number of patients.
4) Evaluation on Clinical Efficacy and Safety
LSK Global PS performs evaluation on the clinical safety compared with the results of non-clinical studies, drug interactions that need to be considered, and values of clinical study results compared to the standard of care or control group. LSK Global PS also performs dose finding that will satisfy efficacy and safety at the dose exploration phase, and selection of enriched target patients, designing subgroup analyses, further clinical studies, etc. based upon the outcomes of such activities.

Study Physician

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 Monitor

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.

Medical Training

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.