Audience

Safety-pharmacovigilance teams in pharma, biotech or device companies interested in a tool for adverse-event monitoring, reporting, and safety-case management

About cubeSAFETY

cubeSAFETY is a pharmacovigilance platform built to help safety teams manage adverse-event reporting, regulatory submission and case processing in a compliant, efficient workflow. The system supports ICH E2B and regional reporting standards, enables submissions to FDA, EMA, CDE, MFDS and PMDA via dedicated gateways, and automatically translates and formats data for CIOMS and XML export. It includes AI-powered medical-coding suggestions, duplication-detection, import of CIOMS PDF files, real-time submission-tracking dashboards, and full integration with other CRScube modules such as cubeCDMS. The platform is designed to streamline safety-case entry, ensure high data quality through built-in validation, and simplify workflows for global regulatory compliance while reducing manual burden and budget overhead.

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Company Information

CRScube
Founded: 2010
South Korea
www.crscube.io/solution/cubesafety

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Product Details

Platforms Supported
Cloud
Training
Documentation
Live Online
In Person
Videos
Support
Phone Support
Online

cubeSAFETY Frequently Asked Questions

Q: What kinds of users and organization types does cubeSAFETY work with?
Q: What languages does cubeSAFETY support in their product?
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