EvidexAdvera Health Analytics
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PvEdgeSarjen Systems
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Related Products
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About
Automated surveillance of any data source, fully integrated with a GVP IX compliant signal management platform. GVP-IX compliant signal management platform integrated within Evidex and ready to use off-the-shelf. Modernize and audit-proof your management processes without having to move back and forth between platforms and services. Unlock the value of your safety data. When you automate signal detection and management, you can focus not just on regulatory requirements, but on driving value for your organization. Identify safety signals from traditional sources like ICSR databases, FDA Adverse Event Reporting System (FAERS), VigiBase and clinical trial data. Include new data sources such as claims, EHR, and other unstructured data. Bring these pools of information together seamlessly to enhance signaling algorithms, make validations and assessment more efficient, and provide faster answers to drug safety questions.
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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
Pharmacovigilance software for pharmacies wanting to detect, manage, and mitigate drug safety issues
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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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Pros & Cons from Real UsersPros
Cons
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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 InformationAdvera Health Analytics
Founded: 2010
United States
www.adverahealth.com
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Company InformationSarjen Systems
Founded: 1998
India
pvedge.sarjen.com
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Categories |
Categories |
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Integrations
Amazon EC2
Amazon RDS
Amazon Web Services (AWS)
PostgreSQL
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