SERVICE OUTLINE

[ Clinical Trial Services ]

• Construction of an in-house clinical development system taking related regulations into account
• Preparation and review of clinical development-related SOPs
• Planning, designing and preparation of clinical development
• Designing of "Proof of Concept" clinical research
• Preparation and review of the investigator's brochure
• Preparation and review of protocols
• Preparation and review of the informed consent form and explanatory documents
• Preparation and review of the case report form
• Selection of medical institutions that would participate in clinical studies
• Assessment of the investigator and participating medical institutions
• Preparation, review and modification of application forms to be submitted to the institutional review board in each participating medical institution
• Monitoring, data management, and management of audits
• Management of safety control and assessment
• Review of the study report
• Management of clinical trials conducted abroad
• Estimation of the cost of clinical studies

[ Regulatory Services ]

• Preparation, review, and modification of documents for consultation with regulatory authorities
• Preparation, review, and modification of documents to be submitted to regulatory authorities with applications for clinical studies
• Management of safety reports presented to regulatory authorities
• Preparation and review of clinical study completion reports submitted to regulatory authorities
• Consultation and negotiations with regulatory authorities and other related agencies