Centralized IRB reviews allow for workload streamlining resulting in speedy study start-up
OPHAC Hospital of Heishinkai Medical Corporation, the first clinical trial hospital in Japan, was opened in 2005, at the same time when its Investigational Review Board (IRB) was established. Since then, clinical trials conducted at Heishinkai Medical Corporation facilities and other trial sites have been centrally reviewed by the OPHAC Hospital IRB.
Utilizing OPHAC Hospital IRB, sponsor challenges of conducting a clinical trial at a facility with no in-house IRB and start-up timeline minimalization being important, are overcome with ease.
◎Meeting Frequency
Regular review meetings are held once every three weeks (16 times a year on average). In addition, Ad-Hoc meetings are scheduled efficiently and held as needed.
◎Consolidated IRB Reviews – Resource, Time and Cost Optimization
For multi-sited studies, utilizing the central IRB eliminates the need for individual IRB review at each of the trial site, thereby reducing the resource burden, associated costs, and start-up timeline.
◎Dedicated & Experienced Full-Time IRB Office
Our dedicated and experienced full-time IRB Office staff provide all relevant details thoroughly to sponsor and trial sites from IRB contracting through to study close-out.
◎Documents Preview
Prior to the Central IRB review, our experienced team previews all relevant drafted documents and provides edits or additional information to further ensure the IRB review will be conducted efficiently and effectively. With our IRB Know-How and experience, the shortest lead time for contract sign-off is the day after the first round of review.
◎Robust Therapeutic Experience
With our extensive IRB review experience, OPHAC Hospital IRB is proficient in reviewing for a wide array of therapeutic areas and indications.
◎Electronic-Submission Able
We accept electronic applications for IRB review materials via Agatha, a clinical trial and clinical research document management cloud service from Agatha Inc.
OPHAC Hospital IRB Experience
Number of IRB meetings from 2005 to June 1, 2023: 280
*Number of IRB meetings by the IRB of Osaka Pharmacology Research Clinic (OPHAC Hospital’s Predecessor; IRB established in 1983): 367
Number of multi-sited trials central IRB reviews (June 1, 2023)
| 2 to 4 sites | 243 |
| 5 to 9 sites | 23 |
| 10 to 14 sites | 5 |
| 15 sites | 1 |
Number of initial IRB reviews (June 1, 2023)
Healthy Volunteer Trials
| Phase I trials (excluding FIH and FIJ) | 236 |
| FIH (First in Human) | 30 |
| FIJ (First in Japanese) | 19 |
| Bioequivalence | 144 |
| Bioavailability | 11 |
| Patch Tests | 4 |
Patient Trials
| Endocrinology and Metabolism | 124 |
| Ophthalmology | 78 |
| Cardiovascular | 24 |
| Respiratory | 18 |
| Otorhinolaryngology | 17 |
| Dermatology | 10 |
| Orthopedics | 9 |
| Neuropsychiatry | 9 |
| Nephrology | 6 |
| Urology | 5 |
| Gastroenterology | 3 |
| Gynecology | 2 |
IRB Fees
From JPY300,000 for initial central review
*Costs vary depending on the type of study and number of sites to be reviewed.
*Costs vary depending on the type of trial and number of trial sites.
For inquiries, please contact us using the form below.
Meeting Schedules
Our IRB meetings are regularly held once every three weeks on Thursday.
*Ad-Hoc meetings will be held as needed.
IRB Members
| Name | Organization | Category* | Qualification | Remarks |
| Kaori Inazawa | Director, Inazawa Clinic | ②, ③ | Physician | |
| Toshifumi Kagiya | Director, Imperial Hotel Clinic Occupational Health Consultant | ②, ③ | Physician | Chairperson |
| Shigenao Katsui | Katsui Law Office Osaka Bar Association | ① | Lawyer | |
| Tomohiro Katsuya | Director, Katsuya Clinic Special Appointed Associate Professor of Medicine, Department of Clinical Gene Therapy, Graduate School of Medicine, Osaka University | ②, ③ | Physician | |
| Eri Kawanishi | Hanshin Partners Hyogo Bar Association | ① | Lawyer | |
| Hironori Nakagami | Professor, Department of Health Development and Medicine, Graduate School of Medicine, Osaka University | ②, ③ | Physician | |
| Makiko Maeda | Associate Professor, Graduate School of Pharmaceutical Sciences, Osaka University | ②, ③ | Pharmacist | |
| Kiyoji Yabunaka | IRB Office Manager, OPHAC Hospital | ① | － | Vice Chairperson |
Clinical Trial Review Committee Members (April 1, 2023) *Categories of committee members are listed by number according to the following classifications: (1) Non-expert committee member
*1: Member not with the scientific expert background
*2: Member independent of the trial site (excluding 1 above)
*3: Member independent of the IRB establisher (excluding 1 above)
*4: Member other than 1 to 3 above