cubeSAFETY

cubeSAFETY

CRScube
+
+

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About

OpenSourcePV is a company founded by Lionel Van Holle in 2019 with the ambition to make use of free & open source technologies to raise the standards of pharmacovigilance and provide an affordable & competitive alternative to expensive software specialized in pharmacovigilance. To meet their regulatory obligations, pharma companies need to monitor the safety of their products. When they start to have a strong pipeline and multiple products on the market, the amount of data to be reviewed is soon too large to be reviewed manually. To benefit from quantitative analysis, they currently have two options: either they use an expensive suite of tools or they try to build something on their own. With OpenSourcePV, we accompany their journey in quantitative signal detection allowing them to benefit from pre-built modules and building something customized to their specific needs and data sources.

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

Healthcare and pharmaceutical enterprises in search of a solution to monitor product safety and perform quantitative signal detection

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 Not Supported
24/7 Live Support Not 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

Free
Free Version 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 Not Supported
Live Online Not Supported
In Person Not Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Supported

Company Information

OpenSourcePV
Founded: 2019
United States
www.opensourcepv.com

Company Information

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

Alternatives

Alternatives

SafetyEasy

SafetyEasy

AB Cube
Fusion eClinical Suite

Fusion eClinical Suite

Axiom Real-Time Metrics
Thrana Safety Database

Thrana Safety Database

Thrana Softech
PvEdge

PvEdge

Sarjen Systems
Clienvo eTMF

Clienvo eTMF

Clinevo

Categories

Pharmacovigilance Supported

Categories

Pharmacovigilance Supported

Integrations

XML Not Supported
cubeCDMS Not Supported
cubeCTMS Not Supported

Integrations

XML Supported
cubeCDMS Supported
cubeCTMS Supported
Claim OpenSourcePV and update features and information
Claim OpenSourcePV and update features and information
Claim cubeSAFETY and update features and information
Claim cubeSAFETY and update features and information