Study Sites Specialized in Clinical Trials
Heishinkai study sites were designed specifically for clinical trial conduct. Their architecture and facilities including the combined capacity of 300 outpatients per day and multiple SDV rooms enable clinical trials to be conducted efficiently and effectively.
Large Capacity
Heishinkai study sites are specialized in clinical trials, thus experienced and proficient in enrolling large subject pools as well.
- Outpatient capacity: combined total of 300 subjects per day
- Inpatient capacity: combined total of 84 subjects per day
Open All Year Round
The sites are open on Saturdays, Sundays and public holidays as well, allowing for maximum accommodation for even unexpected/sudden changes in visit schedules. This helps avoid potential protocol deviations. After-hour visit scheduling is also possible per needed.
SDV Rooms
There are 5 SDV rooms at each of the 3 study sites, allowing sponsors to review source documents for long duration, uninterrupted. Each room is equipped with sponsor-exclusive LAN in addition to wifi internet.
Heishinkai can arrange for remote SDV by allowing access to PDF-converted source documents via the CLOUD.
Strict Control of Investigational Drugs
Each of the 3 study sites has a designated drug storage room in which investigational drugs are stored with strict access and security control. Temperature is also strictly controlled with 24-hour air conditioning. Temperature is tracked and logged. Freezers and refrigerators are equipped with an alarm system. In the event that temperature deviation occurs, the drug manager and assistant will be alerted immediately.
Proprietary Clinical Trial Management System
Heishinkai has its proprietary clinical trial management system. The system centrally manages trial participation history, drug withdrawal periods, subject visit information, and visit schedule tolerance.
Subject Barcoding System
Subject information is managed via our barcoding system. Barcodes are scanned to check for subject and sampling IDs matching to ensure zero possibility of mix-up.
Emergency Back-Up Power Supply
All Heishinkai study sites are equipped with emergency back-up power supplies so that power can be supplied for a certain period of time in the event of a temporary power outage due to natural disasters. With the emergency back-up power supply, refrigerators and freezers where investigational drugs and specimens are stored are maintained at the same constant temperature for a certain period of time.
OPHAC Hospital Highlights
Safety and Security Measures
The investigational drugs and document storage rooms are equipped with a high-capacity halogen fire extinguishing system, eliminating the risk of water damage or staining from sprinkler or foam fire extinguishing systems. For security, entrance to storage areas is strictly control with restricted access via IC security.
Governance Under One Corporation
The 3 Heishinkai study sites are governed by the same SOPs. Close connection among the sites ensures uniform quality. For multi-sited studies, the sites share all relevant information on the study progress and make appropriate adjustments to subject enrollment where possible to further enhance speed, leading to the shortest trial period possible. Risk mitigation and improvement measures are jointly developed to ensure the most effective and efficient conduct of the clinical trials.
On-Schedule Study Conduct Through Our Strong Collaborative Infra
Pre-Trial
– Study team staff members plan for study activities and risk management based on the same study information.
– CRCs and Subject Management Office develop optimal and achievable study schedule based on site capacity.
– Upon thorough consideration of all shared information across sites, study schedule is final and recruitment kicks in.
During the Trial
– The 3 Heishinkai study sites have good visibility to the progress of all ongoing trials no matter the site, allowing for effective support from another site if any unexpected delay surfaces.
Site Options in Tokyo and Osaka
Depending on the sponsor’s location and/or recruitment logistics, e.g. pollen concentrations consideration for allergy trials, OPHAC Hospital (Osaka), OCROM Clinic (Osaka) and/or ToCROM Clinic (Tokyo) can be offered/requested.
Inpatient Clinical Pharmacology Trials
The 3 Heishinkai study sites are capable of conducting short-term and long-term trials. Through our solid infra, conduct of one single clinical pharmacology trial with over 50 subjects can be achieved with ease. Frequent blood sampling and tests generally required by such trials are managed well by our skilled staff who are well-trained for clinical pharmacology as well as complex trials.