SafetyEasyAB Cube
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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
Efficient drug safety operations with the technological expertise of industry veterans begins here.
Align international pharmacovigilance operations teams with an intuitive, unified, cloud-based safety system trusted by industry leaders. SafetyEasy® Suite is a multivigilance management solution which integrates automation with existing drug safety processes.
Growing biotechnology firms trust individual vigilances provided by AB Cube for their safety regulatory processes. Life sciences organisations manage adverse event reporting and stay compliant with the latest regulations with SafetyEasy® Suite.
SafetyEasy® Suite is AB Cube’s all-in-one ecosystem for automated multivigilance management. Built to make safety simple, scalable, and smart. Designed for organizations of all sizes, it’s a modular, cloud-based platform that automates every step of the vigilance process, from early stage data capture to regulatory reporting and advanced analytics.
Flexible and compliant by design,
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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
Life sciences organizations wanting a solution to manage increasing volumes of safety cases and regulatory requirements in pharmacovigilance and related fields
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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 |
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 InformationAB Cube
Founded: 2006
France
www.ab-cube.com/vigilance/
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Integrations
Microsoft SharePoint
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