Oracle ArgusOracle
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cubeSAFETYCRScube
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Related Products
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About
The market-leading, trusted solution for processing, analyzing, and reporting adverse event cases originating in premarket and post-market drugs, biologics, vaccines, devices, and combination products. Transform your case management efficiency with innovative capabilities, such as built-in automation, workflow optimization, and conditional touchless processing. You can depend on Argus, a mature, reliable solution providing proven compliance with drug, vaccine, and device regulations and standards in all regions of the world, including E2B(R3), E2B(R2), eVAERS, eMDR, MIR, and IDMP. Argus Advanced Cloud includes Oracle Analytics, a powerful, flexible, AI-powered solution that empowers users to uncover new insights and make faster, more informed business decisions. Medicinal product safety teams face enormous pressure to control ever-increasing caseloads, new sources of signal detection data, and changing regulations, all with flat budgets and resources.
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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
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Audience
Pharmaceutical companies in need of a tool to manage rapidly increasing caseloads and changing regulations
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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
Supported
24/7 Live Support
Supported
Online
Supported
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Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Supported
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API
Offers API
Not Supported
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API
Offers API
Not Supported
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Not Supported
Free Trial
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Pricing
No information available.
Free Version
Not Supported
Free Trial
Not Supported
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Reviews/
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Reviews/
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Training
Documentation
Supported
Webinars
Supported
Live Online
Supported
In Person
Supported
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Supported
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Company InformationOracle
Founded: 1977
United States
www.oracle.com/life-sciences/safety-solutions/argus-safety-case-management/
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Company InformationCRScube
Founded: 2010
South Korea
www.crscube.io/solution/cubesafety
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Alternatives |
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Categories |
Categories |
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Integrations
AccelSafety
Supported
Compier Literature Screening
Supported
Oracle Analytics Cloud
Supported
XML
Not Supported
cubeCDMS
Not Supported
cubeCTMS
Not Supported
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Integrations
AccelSafety
Not Supported
Compier Literature Screening
Not Supported
Oracle Analytics Cloud
Not Supported
XML
Supported
cubeCDMS
Supported
cubeCTMS
Supported
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