For companies interested in clinical trials
Business Achievements
Yakuriken Co., Ltd. has abundant experience in the following cases
- Internal Medicine
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- Diabetes
- Gastrointestinal disorders
- Hypertension
- Renal disorders
- Hyperlipidemia
- Psychiatry
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- Major Depression
- Schizophrenia
- Bipolar Disorder
- Insomnia
- Neurology
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- Alzheimer's
- Parkinson's disease
- Migraine
- DLB
- Respiratory Medicine
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- Chronic asthma
- Upper respiratory tract infection
- COPD
- Allergic disorders
- Orthopedics
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- RA
- OA
- Low back pain
- Osteoporosis
Percentage of total contracts
(FYE Mar. 2024)
- Psychiatry
- Cardiology
- Neurology
- Internal Medicine
- Gynecology
- Respiratory
- Orthopedics
- Gastroenterology
- Other
Contracted Protocols by Phase
(FYE March 2024)
- After Sales
- Phase 2 Trial
- Phase 3 Trial
For Pharmaceutical Companies
Bringing New Drugs into the Clinical Field
In the process of drug development, which requires many years and much effort, clinical trials play an important role in bringing the results of research to clinical practice. Yakuriken smoothly connects pharmaceutical companies and medical institutions that wish to conduct clinical trials, making full use of our past experience and the Yakuriken Group's network.
Establishment of Advanced Clinical Trial System
We analyze clinical trial protocols in detail, establish more advanced clinical trial systems, assign competent CRC (Clinical Research Coordinators), and prepare clinical trial systems for clinical sites, such as infrastructure development and education of medical institutions conducting clinical trials.
Community-based social contribution
We pursue a "precise and sincere response" through the recruitment and continued education of local residents. A community-based SMO with good footwork can be expected to manage effectively in order to incorporate difficult clinical trials and to promptly respond to the changing number of subjects coming to the hospital.
Development of Trusted Clinical Trial Services
We have a wealth of experience backed by a relationship of trust with CROs (contract research organizations) and a clinical trial environment based on the new GCP, and provide reliable support for clinical trial operations in terms of quality, cost, and speed.
Flow of Establishment of Clinical Trial System
- Conclusion of basic contract for clinical trial support services
- Establishment of SOP (Standard Operating Procedures)
- Establishment of clinical trial implementation system (establishment of clinical trial office, appointment of clinical trial manager, etc.)
New Clinical Trial Referral Process
Clinical Trial Flow and CRC Support Services
Study of viability of a clinical trial
- Introduction of Clinical Trials
- Information and interviews with physicians in the subject area
Prior to Start of Clinical Trial
- Site survey and selection
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CRC Duties
Support for investigations by medical institutions and investigators
Support for investigation of the number of eligible cases
- Protocol agreement
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Assist in preparation of explanatory and consent documents
Preparation for clinical trials- Coordination with related departments in the hospital
- Meetings with clinical trial sponsors
- Assist in preparation and confirmation of case files, worksheets, etc.
- Clinical trial request (sponsor => Director)
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Assist in preparation and confirmation of IRB review documents
- IRB review
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Attend clinical trial flow IRB meetings to review and respond to instructions and take minutes
- Contract
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Clinical Trial Secretariat
Support for conclusion of clinical trial contracts
Preparation and storage of essential documents
Assistance in preparing invoices for clinical trial expenses
Assistance with calculation of uninsured medical treatment expenses
Assistance with management of burden reduction expenses for subjects
Clinical trial in progress
- Start-up Meeting
Start of case entry
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CRC Duties
Assist with delivery of investigational drugs
Assist in compliance with study protocol
Assist in screening processHandling of test subjects
- Assist in explaining consent and obtaining consent
- Attend medical examinations and tests
- Emergency response desk
- Manage visit schedule
- Confirmation of concomitant medications and adverse events
- Checking compliance with medications and patient diaries
Correspondence with investigators
- Assist in preparation of case report forms
- Assist with subject eligibility studies
- Assist with adverse events
- Assist in safety verification
Clinical trial sponsor support
- Reporting of clinical trial status
- Support for monitoring, SDV, and audits
- Contact point for case report feedback, etc.
- Goal achieved
- Additional cases
At and after completion of clinical trial
- Return of Investigational Drugs
- Flow of Clinical TrialsAssistance in Returning Investigational Drugs
- End of Clinical Trial Report
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Flow of Clinical TrialsSupport for Preparation of End-of-Clinical-Trial Report
Record keeping
- On-site inspection by regulatory authorities
- Flow of Clinical TrialCorrespondence to GCP on-site inspection by regulatory authorities
- New drug launch