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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
Transforming your safety management
Get peace of mind with cubeSAFETY and focus on what truly matters – maintaining safety and accuracy in your clinical trials.
The CRScube Difference
Developed by data managers
We understand your challenges because we've lived them
Continuous innovation
We're always pushing boundaries to serve you better
Loved by users
Our clients especially like the simple communication with regulatory agencies
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
Optimizing clinical trial setup through intelligent automation and cubeCDMS integration
Discover how SevenTwoOne, a CRO, uses AI, RPA, Microsoft Office, and cubeCDMS to transform EDC development, reducing manual effort across specification creation, test data generation, EDC builds, QC, and paper survey processing.
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