PvEdgeSarjen Systems
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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
PvEdge is a cloud-ready pharmacovigilance software designed to provide end-to-end compliant safety solutions for drugs, devices, vaccines, and combination products. It offers a comprehensive safety database that manages pharmacovigilance intake, case processing, submissions, AI & analytics, and safety signals all in one platform. The system adheres to existing and upcoming regulations, such as 21 CFR Part 11, ANNEX 11, GxP, and GDPR, ensuring global compliance. PvEdge utilizes advanced automation powered by AI and machine learning algorithms to enhance efficiency in drug safety database management. Key features include automated literature monitoring, ICSR submissions, smart triage, automated signal detection, and document automation. The platform also provides a controlled document management system for creating, managing, and publishing pharmacovigilance documents, as well as a risk-based enterprise quality management system to implement quality processes and training records.
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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
Pharmaceutical companies and healthcare organizations seeking solution to manage pharmacovigilance activities, ensuring compliance
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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 InformationSarjen Systems
Founded: 1998
India
pvedge.sarjen.com
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Integrations
Microsoft SharePoint
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