EXPERT CLINICAL TRIALS MANAGEMENT FOR JAPAN
We work with clients to progress their pharmaceutical products to market in Japan and help Japanese companies with their business efforts abroad.
In particular, our expertise bridges practical management gaps that companies will typically encounter when engaging in new work within Japan.
Work can cover selection and practical oversight of CROs, consideration of regulatory issues, support of company submissions and other general management.
You may be wanting to conduct a trial in Japan in order to increase your commercial presence, gain direct access to patients, speed up total trial process or reduce overall costs.
Irrespective, if you are considering outsourcing work to external providers in Japan and are concerned about the overall management process, then contact us.
Issues might include consultation on clinical strategy and planning, protocol design, site selection and contracting, initiation and management oversight, potential patient recruitment issues, data management aspects, biostatistical analysis, medical writing issues and translation plus quality assurance and audit.
Our Japan partner PPBiz has high-end experience both within Japan and abroad. We work with large established pharma as well as younger biotechs and CROs.
