HGMI Health has;
A large number of experiences of clinical studies in the US and Japan (As both a sponsor and CRO)
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A lot of experiences in strategic meeting with PMDA (Japanese agency)
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Various experiences in PMDA advising meetings with foreign sponsors, and consulting about applications for PMDA and MHLW, including orphan drug designation application
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Deep knowledge about PMDA requirements for conducting global studies as well as bridging studies
Multiple relationships with reliable CROs, clinical sites, hospitals and consultants in the US and Japan
All essential capabilities and services for conducting clinical studies with Japanese subjects in the US
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Recruitment of Japanese population in the US
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Professional medical translation services
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Professional translation acknowledging the cultural differences in the US and Japan
