1. Working together with clients to build clinical development strategy
Defining target position of your product in Japan market is as critical, as involving patients from Japan for your global study.
Understanding what is different/similar of medical practice, e.g. available drug treatment guideline and diagnostic method using new technology, like gene anaiysis, and epidemiology are key to develop robust patient recruitment strategy.
2. Risk management of clinical operations such as,
Identification of KOLs, Investigators, Sites and Operational Vendors
Only experience of disease treatment is not enough, flexibility and willingness to coordinate with global study system, English language level, etc will all affect the success of the study.
Oversight of clinical operation to assure quality and timeline
Allocation of experienced and bilingual staff who are understanding difference of medical situation between global and Japan is important for smooth progress of study which bring quality and speed.
Access to target patients
Patient access strategy consists of two steps, 1st step is to access through public communication channels such as, advertisement and web communication. 2st step is to utilize multiple technologies such as, NGS, PCR and IHC to screen patients and increase efficiency.