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Submit with confidence, track with precision
Ensuring accurate reporting and regulatory compliance, cubeSAFETY simplifies case report submission and tracking.
Comprehensive safety management
Ensures regulatory compliance with ICH E2B and regional guidelines
Identifies safety signals from diverse data sources
Allows direct submission to FDA, EMA, CDE, MFDS, and PMDA using our dedicated gateways
Automatically translates entered data for CIOMS and XML submissions
Better processes
Provides real-time submission tracking
Prevents and manages duplicate case entries
Simplifies workflows with native AI features
Offers easy access to agency feedback
Simplify your workflow, amplify your impact
Your ultimate safeguard for rigorous pharmacovigilance
AI-powered coding
Recommended medical coding terms and case narratives based on data input
Automated data entry
Import data from CIOMS PDF files with AI efficiency
Data transformation
Seamlessly import and export XML files and ICSR
Local & translated exports
Export raw or translated data as needed in multiple formats
cubeCDMS integration
Create cases with specific information, with bulk submission options
Frequently asked questions (FAQs)
The customer support team was incredibly responsive and helpful, addressing my questions promptly via email, and if needed, video call.
Joanne W.
Biomedical Engineer
Featured case studies
Achieving rapid GCP compliance and seamless trial execution with cubeCDMS build support
Discover how JIHS used cubeCDMS and hands-on implementation support to build and launch a GCP-compliant EDC environment within just two months, while developing the internal expertise needed to support future double-blind clinical trials.
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