Capabilities
Clinical Development & Clinical Network
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Clinical Development & Clinical Network
Clinical development support and a network of healthcare institutions work together — from study design, data management and statistical analysis through to the connection with clinical practice — each within its own sphere of responsibility.
Contents
01
Clinical development support
03
Clinical development functions
02
Clinical Network
Contents
01
Clinical development support
02
Clinical Network
03
Clinical development functions
Overview
Clinical development support
Research and clinical development are supported through the clinical development functions of Medbis Co., Ltd. and the Sinclair Clinical Network. Planning, monitoring, data management, statistical analysis and regulatory submission support are brought in according to what the research or development requires.
Clinical Development Support / MedBis
PLANNING
Study planning and design, and secretariat support for clinical research.
MONITORING
Monitoring.
DATA MANAGEMENT & BIOSTATISTICS
Data management and statistical analysis.
PRODUCT DEVELOPMENT & REGULATORY SUPPORT
Product development and support for regulatory submissions.
Clinical Network
The Sinclair Clinical Network is a network of healthcare institutions operated by Advalife Science. Each institution provides medical care as a healthcare provider in its own right and under its own responsibility.
Where clinical research or a clinical trial is conducted, it is conducted separately from routine medical care, in accordance with the applicable laws and guidelines, the study protocol, ethical review and any other procedures required.
GINZA
SINCLAIR GINZA CLINIC
A healthcare institution providing clinical care. It has had a Class II regenerative medicine provision plan accepted under the Act on the Safety of Regenerative Medicine.
SHINSAIBASHI
SINCLAIR SHINSAIBASHI CLINIC
Provides clinical care and works with us as one site in the Sinclair Clinical Network.
SHIBAURA
SINCLAIR BLUE FRONT SHIBAURA CLINIC
Provides clinical care and works with us as one site in the Sinclair Clinical Network.
This does not mean that every institution in the Sinclair Clinical Network is a study site for every development programme or clinical trial. Where a trial or study is conducted, the requirements and procedures are confirmed case by case.
Clinical decisions are made independently by each institution and the attending physician, in accordance with the applicable laws and regulations.
Clinical Development Functions
Clinical development support
Planning and design, secretariat support, monitoring and other clinical development work, according to what the research or development requires.
Data management
Data obtained in research and clinical development is managed in accordance with the study protocol and the applicable procedures, laws and regulations.
Statistical analysis and submission support
Statistical analysis of the data, and support for the regulatory submissions that the research or product development calls for.
Real-World Data
Medical information arising in clinical practice is not used as research data as a matter of course. Any use of real-world data or other such information for research is carried out in accordance with the applicable laws, ethical review, the study protocol, the consent required and any other procedures.
Clinical decisions at a healthcare institution and decisions about research and clinical development are made by those responsible for each, in accordance with the applicable laws and ethical procedures.
Enquiries about clinical development
We welcome enquiries about clinical trials and clinical development, clinical development support, data management, statistical analysis and research collaboration.