cubeSAFETY

cubeSAFETY

CRScube
+
+

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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.

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.

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

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

Audience

Pharmaceutical companies in need of a tool to manage rapidly increasing caseloads and changing regulations

Audience

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

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Supported

Company Information

Oracle
Founded: 1977
United States
www.oracle.com/life-sciences/safety-solutions/argus-safety-case-management/

Company Information

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

Alternatives

SafetyEasy

SafetyEasy

AB Cube

Alternatives

SafetyEasy

SafetyEasy

AB Cube
Thrana Safety Database

Thrana Safety Database

Thrana Softech
AccelSafety

AccelSafety

Techsol Life Sciences
Clienvo eTMF

Clienvo eTMF

Clinevo
TARA PV

TARA PV

MedGenesis

Categories

Pharmacovigilance Supported

Categories

Pharmacovigilance Supported

Integrations

AccelSafety Supported
Compier Literature Screening Supported
Oracle Analytics Cloud Supported
XML Not Supported
cubeCDMS Not Supported
cubeCTMS Not Supported

Integrations

AccelSafety Not Supported
Compier Literature Screening Not Supported
Oracle Analytics Cloud Not Supported
XML Supported
cubeCDMS Supported
cubeCTMS Supported
Claim Oracle Argus and update features and information
Claim Oracle Argus and update features and information
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Claim cubeSAFETY and update features and information