Oracle Announces Integration of Oracle® Adverse Event Reporting System With DrugLogic Qscan
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Oracle has announced the integration of DrugLogic Qscan with Oracle® Adverse Event Reporting System (AERS), a solution for product safety monitoring and pharmacovigilance that tracks events from multiple sources, including the internet, patients and physicians.
The integrated applications provide an enterprise risk management architecture that is designed to leverage advanced analytics to help enhance safety monitoring capabilities and streamline compliance with pharmacovigilance requirements.
"Integration of Oracle AERS and DrugLogic Qscan provides superior safety signal detection and safety surveillance capabilities within a vendor-supported platform that is unparalleled in the life sciences industry," said Mychelle Mowry, vice president for Global Health Industries at Oracle.
"Oracle AERS together with Qscan - which further extends Oracle's end-to-end solutions for the life sciences industry - equips pharmaceutical and biotech companies with a powerful lens that enables them to rapidly analyze patterns in adverse events that may indicate emerging drug safety risks pre- and post-market, enabling faster response times and streamlined compliance."
"Moving forward, we plan to continue building out the integration of Qscan with other Oracle life sciences products, including Oracle Clinical and Oracle Clinical Data Repository."
Qscan, DrugLogic's workflow-based analytical tool for identifying, analyzing and resolving drug safety risks, works with Oracle AERS case data as well as data from external sources, such as the U.S. Food & Drug Administration and the World Health Organization.
International safety and pharmacovigilance regulations require manufacturers to constantly monitor their data to proactively detect safety risks with their products.
Oracle AERS pharmacovigilance users can now immediately visualize their case data in Qscan and utilize Qscan's data mining and signal detection capabilities to focus on the cases of most interest.
In addition, drug safety teams can establish thresholds for automatic safety signal detection, receive alerts when thresholds are reached or exceeded, and assess their case information using data mining tools for statistical analysis.
Oracle AERS includes a query-by-example module that allows users to mine and visualize data through inquiries utilizing multiple case data elements.
Users can perform queries using advanced dictionary relationships, or return data based on Standardized MedDRA Queries (SMQs).
Users can then transfer case lists from these complex queries to Qscan for further analysis. Significant findings within Qscan can then be flagged within AERS for ongoing analysis and monitoring.
This bi-directional data flow allows for constant safety surveillance by both safety operations and pharmacovigilance teams.
Qscan integration also enables immediate investigation of adverse event data against publicly available data sources. Drug safety teams can monitor and analyze - in a single view - legacy, clinical, and pre- and post-market adverse event data.
Team members can also view datasets individually and in association, providing immediate insight into critical indicators, such as change ratios and behaviors over time.
In addition, Qscan offers patented processes and data mining techniques. A significant technique is correlation to see association across drugs and reactions, and to see association with age and gender as well.
"The integration of Oracle AERS and Qscan provides a powerful new tool to the life sciences industry, helping pharmaceutical and biotech organizations in their quest to ensure the safety of the products that they bring to market," said DrugLogic President and Chief Executive Officer Victor Gogolak.