PvEdgeSarjen Systems
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Related Products
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About
OpenSourcePV is a company founded by Lionel Van Holle in 2019 with the ambition to make use of free & open source technologies to raise the standards of pharmacovigilance and provide an affordable & competitive alternative to expensive software specialized in pharmacovigilance. To meet their regulatory obligations, pharma companies need to monitor the safety of their products. When they start to have a strong pipeline and multiple products on the market, the amount of data to be reviewed is soon too large to be reviewed manually. To benefit from quantitative analysis, they currently have two options: either they use an expensive suite of tools or they try to build something on their own. With OpenSourcePV, we accompany their journey in quantitative signal detection allowing them to benefit from pre-built modules and building something customized to their specific needs and data sources.
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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
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Audience
Healthcare and pharmaceutical enterprises in search of a solution to monitor product safety and perform quantitative signal detection
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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
Not Supported
24/7 Live Support
Not Supported
Online
Supported
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Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Supported
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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
Free
Free Version
Supported
Free Trial
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Pricing
No information available.
Free Version
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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
Supported
Webinars
Not Supported
Live Online
Not Supported
In Person
Not Supported
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Supported
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Company InformationOpenSourcePV
Founded: 2019
United States
www.opensourcepv.com
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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
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