souseikai global clinical research center

Phase 1 and POC in ONE Study Protocol

In recent years, we have seen a growing trend where many sponsors have started to include target disease patients in their Phase 1 healthy volunteer studies to see preliminary efficacy data in addition to safety, tolerability, and PK profiles of their IPs. This new trend is not limited to global pharmaceutical companies who want to accelerate their drug development to commercialize their products first in their target markets in order to secure the patents and enjoy commercial advantages. This development strategy is also beneficial to biotech companies who are hoping to license out their products because they can offer better out-licensing deals with human efficacy data compared to those with no efficacy data.

At SOUSEIKAI, leveraging our advantages as a part of our larger medical group with 8 general hospitals, we are capable of conducting Phase1/POC studies in ONE study protocols, significantly shortening our sponsors’ development timeline and reducing their overall study budgets.