Tokyo / Barcelona.

Bioinfogate will integrate JADER case reports and pharmacovigilance signals into OFF-X to complement its unique translational view of safety intelligence.

Bioinfogate, a leading healthcare data science organization, today announced it has entered into a global agreement with INTAGE Healthcare (hereafter "INTAGE") to integrate Japanese pharmacovigilance insights from the JADER database (the Pharmaceuticals and Medical Devices Agency (PMDA) database of spontaneous adverse drug reaction reports in Japan).

Based on its long standing experience managing and curating the JADER and FAERS databases, INTAGE will provide a curated dataset of case reports and derived signals to be integrated with OFF-X’s expertly curated safety data and analytics. INTAGE is the producer of the CzeekV Pro database system, offered since 2010, a curated database of FAERS and JADER spontaneous adverse reports and signals based on well-established methods used by a variety of regulatory bodies worldwide.

By delivering critical integrated target discovery, preclinical toxicity, clinical adverse event intelligence and pharmacovigilance insights coupled to advanced analytics, Bioinfogate OFF-X™ allows safety liabilities to be monitored and anticipated across all phases of drug R&D and post-marketing. OFF-X is updated daily: more than 4,000 expertly curated alerts are added to the portal each week.

Launched in 2016, OFF-X is used across pharma and biotech organizations, in leading research centers and by regulatory bodies around the world, addressing the need for new approaches to enhance safety assessments that can reduce patient burden and avoid costly failures.


About Bioinfogate

Bioinfogate is a forward-thinking, private company working to solve unmet medical needs. Our innovative data science products support the discovery and development of better and safer drugs. We are committed to building industry-leading solutions and identifying and investing in emerging projects that align with our core business in the life sciences and data analytics.

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About Bioinfogate OFF-X

The Bioinfogate OFF-X™ portal provides integrated target discovery, non-clinical and clinical adverse event intelligence and pharmacovigilance insights for drugs and targets in all phases of drug R&D and post-marketing. As of October 2020, the portal covers a range of over 15,000 targets and almost 19,500 drugs & biologics, and is populated with more than 875,000 expertly curated safety alerts associated to over 9,000 adverse effects. OFF-X is used across pharma and biotech organizations, in leading research centers and regulatory bodies.


About INTAGE Healthcare

INTAGE Healthcare combines deep knowledge of clinical practice with the INTAGE Group’s abundant resources and strength in consumer insights to provide healthcare consumers, providers, manufacturers, and service companies with the information they need to make healthier decisions.

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About INTAGE Healthcare CzeekV Pro

The INTAGE Healthcare CzeekV Pro is a system that searches publicly available spontaneously reported adverse event databases for the relationship between drugs and adverse events using statistical analysis methods. The system integrates JADER and FAERS, and calculates and registers score values indicating the relationship between "drugs-adverse events". The score value is calculated as a statistical method to evaluate significance and adopts the same method as the world's major regulatory institutions and displays four score values.

It is also equipped with an age-specific histogram, signal distribution map, detailed statistical analysis function by age and gender, and a report list browsing function, which are useful as safety monitoring tools and analysis tools.

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