cubeSAFETY

cubeSAFETY

CRScube
+
+

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About

NewTn's SAFETY is an advanced pharmacovigilance cloud platform designed to accelerate safety processes and simplify compliance for pharmaceutical companies, startups, and contract research organizations. The system offers a comprehensive suite of features, including cloud-based scalability for superior data storage and processing capabilities, data reusability to eliminate redundant entries, real-time alerts and monitoring for prompt adverse reaction detection, and robust reporting functions that facilitate the generation of DSUR and PBRER reports. Tailored use cases highlight its benefits in establishing pharmaceutical safety databases for startups, providing cost-effective safety systems for budget-sensitive CROs, enhancing regulatory compliance for small and medium-sized pharmaceutical companies, and delivering comprehensive safety data analysis and reporting. The platform's intuitive UI/UX and support for DSUR/PBRER reporting make it a customized solution.

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
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Organizations in need of a tool to efficiently manage pharmacovigilance activities and ensure compliance with international safety 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
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

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:

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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
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

NewTn-SAFETY
United States
safety.newtn.life/

Company Information

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

Alternatives

Alternatives

SafetyEasy

SafetyEasy

AB Cube
Thrana Safety Database

Thrana Safety Database

Thrana Softech
PharmaPendium

PharmaPendium

Elsevier
Clienvo eTMF

Clienvo eTMF

Clinevo

Categories

Categories

Integrations

XML
cubeCDMS
cubeCTMS

Integrations

XML
cubeCDMS
cubeCTMS
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