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Average Ratings 0 Ratings

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ease
features
design
support

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Description

Enhance the speed at which products reach the market by organizing, implementing, and monitoring all regulatory processes within a cohesive RIM application that offers easy access to regulatory documentation and comprehensive support for major eCTD submission standards. The integrated automation simplifies workflows, minimizing administrative tasks and increasing trust in the quality of product registration data. By utilizing this unified approach, organizations can ensure a more efficient regulatory process while maintaining high standards of compliance and accuracy.

Description

cubeSAFETY is an advanced pharmacovigilance platform designed to assist safety teams in efficiently managing adverse-event reporting, regulatory submissions, and case processing in a compliant manner. It adheres to ICH E2B and various regional reporting standards, facilitating submissions to agencies like the FDA, EMA, CDE, MFDS, and PMDA through specialized gateways, while also automatically converting and formatting data for CIOMS and XML export. The platform boasts AI-driven medical coding suggestions, duplication detection, the capability to import CIOMS PDF files, and dynamic dashboards for real-time submission tracking. Additionally, it offers complete integration with other CRScube modules, including cubeCDMS. cubeSAFETY is crafted to enhance the safety-case entry process, guarantee superior data quality through embedded validation features, and streamline workflows for compliance with global regulatory requirements, all while decreasing manual labor and financial overhead. Ultimately, this innovative platform aims to redefine pharmacovigilance efficiency and accuracy across the industry.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

LifeSphere eTMF
XML
cubeCDMS
cubeCTMS

Integrations

LifeSphere eTMF
XML
cubeCDMS
cubeCTMS

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

ArisGlobal

Founded

1987

Country

United States

Website

www.arisglobal.com/lifesphere/regulatory/rims-software/

Vendor Details

Company Name

CRScube

Founded

2010

Country

South Korea

Website

www.crscube.io/solution/cubesafety

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