cubeSAFETY 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.
cubeSAFETY Alternatives
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Clienvo eTMF
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Integrations
Company Details
Company:
CRScube
Year Founded:
2010
Headquarters:
South Korea
Website:
www.crscube.io/solution/cubesafety
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Product Details
Platforms
Web-Based
Types of Training
Training Docs
Live Training (Online)
In Person
Training Videos
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Business Hours
Online Support
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