For medical institutions
Advantages of Conducting Clinical Trials
- You can contribute to the improvement and development of medical care.
- You will have access to the latest information on drug development and experience with treatments.
- You can promote yourself as a facility that provides cutting-edge medical care both in and outside your institution.
- The hospital will be able to meet the needs of patients who desire cutting-edge medical care.
- Motivation and engagement among hospital staff can be expected.
- The research funds obtained from the implementation of clinical trials can be used for managerial benefits.
Role of SMO (Site Management Organization)
Clinical trials conducted on human subjects are required to comply with the standards established by the Ministry of Health, Labour and Welfare (GCP: Ministerial Ordinance on Standards for Conducting Clinical Trials on Drugs). Yakuriken supports the operations of medical institutions conducting clinical trials based on in-depth analysis and planning of the details of the trials to ensure that the trials are conducted properly and in compliance with standards, while allowing patients to participate in the trials with peace of mind. The use of an SMO greatly reduces the burden on physicians, nurses, and administrative staff.
SMO Business
SMOs are divided into the following two main business categories
Site Management Associate (SMA)
SMA prepares complicated procedural documents and operates and manages the Clinical Trial Review Committee on behalf of the site conducting the clinical trial. This enables the implementation of clinical trials in compliance with the clinical trial protocol, GCP and other regulations. In addition, they support the proper progress of clinical trials by negotiating with pharmaceutical companies that request clinical trials and performing clerical work related to clinical trials.
Clinical Research Coordinator (CRC)
CRC (Clinical Research Coordinator) with medical expertise is assigned to the medical institution conducting the clinical trial to provide sufficient informed consent to patients participating in the clinical trial, manage the clinical trial schedule and overall clinical trial data under the guidance of the principal investigator and subinvestigator. They provide total management including coordination within the team involved in the clinical trial to ensure a smooth clinical trial.
Full support system for trial sites
Main Support Services
Clinical trial secretariat
- IRB secretariat
- Support for conclusion of clinical trial contracts
- Schedule coordination of monitoring visits
- Preparation and storage of essential documents
- Preparation for and response to regulatory investigations
Clinical investigator support
- Assistance in drafting explanatory and consent documents
- Assistance in explaining consent
- Assistance with screening
- Assistance in compliance with clinical trial protocol
- Assistance in preparation of case report forms
- Assistance with subject eligibility studies
- Assist with adverse event response
- Assist with safety verification
Medical and accounting services
- Assistance in preparing invoices for clinical trial expenses
- Assistance with calculation of uninsured medical treatment expenses
- Assistance with the management of the cost for reducing the burden on subjects
Co-medical support
- Holding meetings for collaborators
- Briefing sessions held for each department(Pharmacy, Laboratory, Nursing, Radiology, Medical Affairs)
- Assistance in carrying in and collecting investigational drugs
Assistance in dealing with subjects
- Assistance in explaining consent and obtaining consent
- Attendance at medical examinations and tests
- Emergency response desk
- Management of hospital visit schedule
- Confirmation of concomitant medications and adverse events
- Checking compliance with medications and patient diaries
Sponsor support
- Responses to investigator eligibility surveys
- Reporting of Clinical Trial Status
- Monitoring, SDV, and audit
- Point of contact for case report feedback