DF mSafety AIDatafoundry
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PvEdgeSarjen Systems
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Related Products
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About
DF mSafety AI is a cloud-based safety platform that leverages AI/ML and automation to enhance efficiency and user experience in safety case management and signal detection for drugs, cosmetics, vaccines, nutraceuticals, and medical devices. Built on Datafoundry's loud platform, DF Safety 4.0, it supports scalable and secure AI/ML-driven safety case and signal management, with pre-built connectors to enterprise systems, adhering to regulatory requirements and industry standards. Key features include multi-source case intake options, automated triage rule configuration, seriousness prediction, causality assessment, expectedness and listedness assessment, auto narrative generation, custom report generation, literature monitoring for safety, signal and risk management, case compliance alerts, integrated MedDRA and WHO-DD browsers, enhanced E2B R2 & R3 compliance, and an e-submissions gateway.
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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
Pharmaceutical companies requiring a solution to transform their safety vigilance processes through AI-powered automation
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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
No information available.
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 InformationDatafoundry
Founded: 2016
India
datafoundry.ai/m-safety/
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Company InformationSarjen Systems
Founded: 1998
India
pvedge.sarjen.com
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Categories |
Categories |
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Integrations
DF Literature Monitor
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