PvEdgeSarjen Systems
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SafetyEasyAB Cube
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Related Products
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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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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
Pharmaceutical companies and healthcare organizations seeking solution to manage pharmacovigilance activities, ensuring compliance
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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
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 InformationSarjen Systems
Founded: 1998
India
pvedge.sarjen.com
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Company InformationAB Cube
Founded: 2006
France
www.ab-cube.com/vigilance/
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Categories |
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Integrations
EDC Made Easy
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