NEW COLLABORATION BETWEEN BIOINFOGATE AND INTAGE HEALTHCARE TO DELIVER JAPANESE PHARMACOVIGILANCE INSIGHTS IN OFF-X
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.
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.
For more information visit www.bioinfogate.com
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.
For more information visit https://www.intage-healthcare.co.jp/
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.
For more information visit https://pro.czeek.com/
CLARIVATE ACQUIRES BIOINFOGATE, REINFORCING POSITION AS PREMIER PROVIDER OF END-TO-END RESEARCH INTELLIGENCE SOLUTIONS FOR LIFE SCIENCES
Expanding and integrating drug toxicity data and translational safety intelligence from OFF-X into all aspects of the life science cycle, allowing customers to make more informed decisions
Aug 04 ,2021
FDA AND BIOINFOGATE AGREE TO EXTEND FOR 2 ADDITIONAL YEARS THE MATERIAL TRANSFER AGREEMENT (MTA) TO PROVIDE AGENCY-WIDE ACCESS TO THE OFF-X TRANSLATIONAL SAFETY INTELLIGENCE PORTAL
The agreement aims to evaluate new approaches to enhance safety assessments of human pharmaceuticals and their associated molecular targets, supporting the FDA’s mission of protecting public health.
May 12 ,2021
EXTERNAL VALIDATION OF BIOINFOGATE’S OFF-X FAERS CURATION PROCESS & STATISTICAL SIGNAL EXTRACTION TO BE SUPPORTED BY INTAGE HEALTHCARE’S CZEEKV PRO
Bioinfogate has established an agreement with INTAGE Healthcare to perform an external validation of their methodologies to curate information from FAERS and extract safety signals using well-established statistical methods with the CzeekV Pro database system.
Mar 22 ,2021