CTMS
Our integrated clinical trial management solution allows centralized monitoring
of the entire trial’s progress and business milestones.
Features
- User-Centered Convenience
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- User-Centered UI/UX Enhancement
- We provide a dashboard where users can easily access information related to MVR, Tracker, Sites, Subjects, and Issues.
- Our system handles clinical trial documents, including Protocol and ICF, and offers features such as MVR File Viewer and Report information inquiry.
- Users can define their own functions, such as MVR templates for specific projects and milestone search and management.
- Our system facilitates MVR creation, visit planning, and reviews by PMs, Sponsors, and other stakeholders.
- Regulatory Compliance and Quality Control
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- System compliant with 21 CFR Part 11 (FDA), Clinical Trial Electronic Data Processing and Management.
- Continuous quality assurance activities are performed by a person in charge with ISO 9001:2015 auditor qualification.
- Our system complies with ISO 27001:2013 Information Security Management Systems.
- Central Monitoring
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- We automatically link RedPine CDMS data and provide manual registration functions.
- Inquiry and registration of clinical trial institutes are streamlined through public data linkage.
- Task confirmation (plan/actual) is available for each study via Basket Study management.
- Provides the ability to register and manage report formats, letters, and versions of letters used throughout the system.
- Data Safety and Protection
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- Microsoft Cloud Azure adheres to major industry standards (ISO/IEC 27001:2013 and NIST SP 800-53).
- Azure Backup ensures data protection through local redundant storage (LRS) and regular backups for recovery.
