Medical Corporation Heishinkai Medical Team – Experience and Strengths

As the industry experienced front-line professionals, each Heishinkai medical staff is committed to meeting sponsor needs and achieving high-speed and quality results through their expertise and experience.
Thriving to contribute to early drug development, the team makes sures to thoroughly understand all study details and maintain the priority throughout the study period to keep the timeline of every step to the minimum. With the inheritance of the corporation’s 40 years of experience, together with their continuous knowledge improvement, the team is one of Heishinkai’s most valuable assets. Even for rare trials, we proactively prepare ourselves for study-readiness thus can offer advice upon request .

Physicians

All of the full-time physicians at Heishinkai have more than 15 years of experience in clinical trials, including experience with PSG (Polysomnography), special clinical pharmacology studies such as intra-alveolar pharmacokinetic studies, bioequivalence studies, FIH (First In Human), and FIJ (First In Japanese) studies. Also, our full-time physicians are ACLS (Advanced Cardiac Life Support) certified. Appropriate investigator assignment is done according to sponsor and/or study needs.

Full-Time Principal Investigator Experience (as of June 1, 2023)
OPHAC Hospital:
Hiroshi Mikami (Director): 129 studies (Phase I/clinical research: 115, >Phase II: 14)
Michio Yagi: 124 studies (Phase I/clinical research: 108, >Phase II: 16)
Hidetoshi Furuie: 136 studies (Phase I/clinical research: 133, >Phase II: 3)
Yasuko Owada: 65 studies (Phase I/clinical research: 55, >Phase II: 10)

OCROM Clinic:
Satoshi Inoue (Director): 159 studies (Phase I/clinical research: 20, >Phase II: 139)
Shigeto Kanada: 85 studies (Phase I/clinical research: 11, >Phase II: 74)

ToCROM Clinic:
Osamu Matsuoka (Director): 183 studies (Phase I/clinical research: 20, >Phase II: 163

CRCs

Over 70% of the CRCs at Heishinkai and affiliated sites have more than 5 years of experience, and diverse knowledge and experience. Many of them have robust indication experience, enabling easy indication-matching CRC assignment.

CRC Experience (as of June 1, 2023)

Nurses

The study ward managers at the 3 Heishinkai study sites have been with Heishinkai for more than 15 years. The rest of the nursing team is equally experienced. Study tasks such as the time critical blood collections are performed reliably on time. Also, our nurses are BLS (Basic Life Support) certified.

Support for Blinded Trials

We can support blinded trials with a high level of flexibility, and can offer larger study team for blinded studies as per needed.

Physician Network

From more than 30 years of clinical trials experience including FIH and FIJ studies, Heishinkai has established a vast physician network across a wide array of therapeutic specialties. In particular, we have established a collaborative network with physicians in neuropsychiatry and ophthalmology for Phase I healthy volunteer trials as well as otolaryngology, ophthalmology, orthopedics, dermatology, and urology patient trials. Matching specialists can be invited as sub- investigators per needed.