OpenSourcePV
Transparent Safety Monitoring
About
In 2014, Lionel started his journey breaking free GSK Vaccines from the monopoly of Empirica Signal (ORACLE) by building an in-house system of signal detection using a mixed solution based on SAS/Spotfire.
With the booming of R packages, he realized that all of the SAS or Spotfire functionalities used for the in house project could be matched or exceeded by R packages. Beyond matching or exceeding current standards, some functionalities brought by packages such as R markdown have the potential to break silos between distinct groups such as reporting, analysis and medical writing and be game changers in the industry.
The current suite of products built by OpenSourcePV includes:
- VAERS Analytics
- FAERS Analytics
- StandAlone Signal Detection
- Competitive Intelligence in Pharmacovigilance
- CrossOrganizational Signal Detection & Management
SOLUTIONS & Services
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
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
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
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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