cubeSAFETYCRScube
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Related Products
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About
K2C PSMF Solution is a modern approach to the management of the Pharmacovigilance System Master File. This document typically requires periodic updates as per significant changes in the pharmacovigilance process. These changes require that multiple company roles are involved in editing a document that is composed of paragraphs and annexes that are all the time same because fixed by regulations. However co-editing is complex; in addition, part of the content should be reserved to some editors and even not available to other contributors. K2C solution allows handling the distinct paragraphs and annexes as single documents, then it offers the possibility to create the PSMF document as a merge of various source documents. K2C PSMF Solution includes management of PSMF contributions (paragraphs and annexes) as distinct documents; management of access rights for viewing or editing of PSMF contributions; and management of the entire lifecycle.
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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.
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Audience
Healthcare companies wanting a tool to streamline their collaboration and regulatory adherence
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Audience
Safety-pharmacovigilance teams in pharma, biotech or device companies interested in a tool for adverse-event monitoring, reporting, and safety-case management
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
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Pricing
€8,500 one-time payment
Free Version
Free Trial
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Pricing
No information available.
Free Version
Free Trial
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Reviews/
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Reviews/
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationK2C
United Kingdom
www.k2c.com/products/K2Pharma/PSMF.html
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Company InformationCRScube
Founded: 2010
South Korea
www.crscube.io/solution/cubesafety
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