Our Support

We support clinical research through activities outlined below.

Identifying Research Seeds	Consultation of seeds leading to research and development from basic research seeds
Seeds Management	Progress management of research and development seeds
Intellectual Property Management	Consultation concerning intellectual property and assistance in completing the Invention Disclosure Form
Business Matching	Support for matching development seeds with company needs
International Collaboration	Collaboration with clinical research support centers abroad; overseas deployment support of research seeds
Development Strategy Planning	Consultation on development strategy, roadmaps, and other planning, as well as non-clinical consultation
Project Management	Project management for development and communication between relevant departments
Developing Pharmaceutical Affairs	Pharmaceutical affairs consultation and negotiation with regulatory bodies
Research Funding	Search for target research funds and support documentation of application
Study Management	Trial schedule planning; construction of trial implementation framework; assistance with protocol or operating procedure writing; documentation for submission to regulatory authorities or management of safety information; operation of coordination office; individual assessment committee, etc.
Medical Writing	Support for creation of the outline of clinical trial medicine, protocol, briefing paper, or informed consent (form template)
Management of Safety Information	Safety information gathering in relation to serious adverse event or such investigational product; report to regulatory authorities, etc. Support for Management of Safety Information
Data Management	Examination of collected data item to accurately evaluate the study purpose; case report form design; case registration, data checking, data encoding, or input method review; design, management, or administration of database
Statistical Analysis	Support in designing clinical study; statistical analysis and bioinformatics data analysis
Monitoring	Ascertain data veracity from source document; confirm case progress; confirm appropriate implementation of clinical study
Document Management	Updating Standard Operating Procedure (SOP); Archving GCP-required document; Editing research papers

Clinical Trial Office	Accept application for clinical trial, conduct interview with sponsor, and perform clerical work as the Institutional Review Board related to the implementation of clinical trial, including support for the meeting of the Institutional Review Board or other document management
Clinical Research Coordinator	Assist with informed consent; support the work of investigator; manage subject's scheduling; care of subject; assist in preparing case report form; manage direct access to source document; in-hospital coordination
Management of Investigational Product	Proper Management of Investigational Product