PvEdgeSarjen Systems
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Related Products
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About
Oracle Life Sciences Empirica is the market-leading solution for detecting, analyzing, and managing safety signals originating in pre- and post-market drugs, biologics, vaccines, devices, and combination products. Oracle continually researches, develops, and advances the state-of-the-art data-mining algorithms and statistical techniques used in Empirica. By enabling the detection of signals with a longer lead time, Empirica can provide risk insights 7 to 22 months earlier than labeling revision dates from a time-indexed benchmark. Safety teams responsible for signal management face new challenges, such as finding hidden signals, assessing information from multiple big data sets, and providing better safety information before clinical trials even begin. Read our ebook to learn how new advances in methodologies and technologies, such as artificial intelligence, can help address these challenges.
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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 operators requiring a solution to detect, analyze, and manage safety risks earlier in multiple big data sets
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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 |
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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 InformationOracle
Founded: 1977
United States
www.oracle.com/life-sciences/safety-solutions/empirica-safety-signal-management/
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Company InformationSarjen Systems
Founded: 1998
India
pvedge.sarjen.com
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Integrations
No info available.
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Integrations
No info available.
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