OpenSourcePV

Transparent Safety Monitoring

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 softwares specialized into 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 to 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. Our mantra is transparency, so whatever is built for them will be owned by them with the ability to modify it to adapt to their future needs. The existing modules are the following ones 'VAERS Analytics', 'FAERS Analytics', 'StandAlone Signal Detection' on their own spontaneous report data and 'Competitive Intelligence' to compare safety profile to existing competitors on the market.

Software as a Service (SaaS)

Software as a Service (SaaS)

Three SaaS are available to the customers 'VAERS Analytics', 'FAERS Analytics' and 'Stand Alone Signal Detection' so that they can get safety insight from the CDC/FDA regulatory database and their own spontaneous report data.

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Consulting

Consulting

Methodological support in quantitative signal detection, observed vs expected, time-to-onset signal detection, implementation of open source technology in the field of pharmacovigilance

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Public Health Initiatives

Public Health Initiatives

Build a signal detection and management tool for the pharmacovigilance community that can be used during crisis times like epidemics for evaluating safety data in parallel from the market authorization holder and the regulatory authorities.

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Competitive intelligence

Competitive intelligence

You are not first-to-market and would like to know how the safety profile of your product differentiates from the competitor.

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Why chosing open source solutions for pharmacovigilance?

Why chosing open source solutions for pharmacovigilance?

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A new era of open source dashboards

A new era of open source dashboards

Open source dashboard - breaking silos between reporting & analytics

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Open Source version of the time-to-onset signal detection algorithm

Open Source version of the time-to-onset signal detection algorithm

Algorithm distributed under GPL license so that it can be used for analyzing data and unravel quantitative signals

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Rmarkdown - a game changer in a regulatory environment?

Rmarkdown - a game changer in a regulatory environment?

The future of reporting & analytics is a merge customer focused

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Presentation at the World Drug Safety Congress Europe in October 2O20 - "Open source technology in supporting Patient Safety"