DF mSafety AIDatafoundry
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cubeSAFETYCRScube
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Related Products
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About
DF mSafety AI is a cloud-based safety platform that leverages AI/ML and automation to enhance efficiency and user experience in safety case management and signal detection for drugs, cosmetics, vaccines, nutraceuticals, and medical devices. Built on Datafoundry's loud platform, DF Safety 4.0, it supports scalable and secure AI/ML-driven safety case and signal management, with pre-built connectors to enterprise systems, adhering to regulatory requirements and industry standards. Key features include multi-source case intake options, automated triage rule configuration, seriousness prediction, causality assessment, expectedness and listedness assessment, auto narrative generation, custom report generation, literature monitoring for safety, signal and risk management, case compliance alerts, integrated MedDRA and WHO-DD browsers, enhanced E2B R2 & R3 compliance, and an e-submissions gateway.
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About
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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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Audience
Pharmaceutical companies requiring a solution to transform their safety vigilance processes through AI-powered automation
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Audience
Safety-pharmacovigilance teams in pharma, biotech or device companies interested in a tool for adverse-event monitoring, reporting, and safety-case management
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Free Trial
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Pricing
No information available.
Free Version
Free Trial
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Reviews/
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Reviews/
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Pros & Cons from Real UsersPros
Cons
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationDatafoundry
Founded: 2016
India
datafoundry.ai/m-safety/
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Company InformationCRScube
Founded: 2010
South Korea
www.crscube.io/solution/cubesafety
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