CoreMed establishes most efficient clinical development strategy and minimum clinical data package for marketing approval.

To reduce the time to NDA submission and minimize risks, it is important to have a well-defined and designed clinical development strategy and to be familiar with the regulatory requirements in each region. CoreMed understands regulatory and medical environments as well as regulations, guidelines and requirements, and advises on how to utilize non-Japanese clinical data.

Furthermore, through our business partnership with A2 Healthcare Corporation, which has extensive experience and a track record in clinical trial management, including monitoring, data management, and statistical analysis, we provide In-Country Clinical Caretaker (ICCC) services on behalf of overseas pharmaceutical companies that have not established a corporation in Japan, fulfilling the role of a sponsor in Japan.