New Updates in Oracle Life Sciences Empirica Streamline Safety Signal Management Compliance in the Cloud
Oracle has announced updates to its Life Sciences Empirica Signal and Topics platform, enhancing global safety signal detection and management capabilities.
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Rhea-AI Summary
Oracle has announced updates to its Life Sciences Empirica Signal and Topics platform, enhancing global safety signal detection and management capabilities. The new release expands database choices for safety monitoring and introduces versioned case-level annotation for detailed single-case assessments. The platform now offers Multisource Signaling across various safety databases, including Oracle Argus Safety, FDA FAERS, VAERS, WHO Vigibase, and PMDA JADER. The system features advanced data mining capabilities with frequentist, Bayesian, and regression-enhanced algorithms to reduce false-positives.
Positive
- Enhanced data mining capabilities across multiple safety databases
- Integration with major global safety databases including FDA FAERS and WHO Vigibase
- Advanced algorithms reducing false-positives in signal detection
- Cloud-based platform offering 24/7 global support and regular updates
Negative
- None.
Details
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Multisource signaling across proprietary and public safety databases, including JADER, enables sophisticated data mining and GVP-compliant signal tracking globally
"Powered by Oracle's extensive technology and data resources, our world-class team of statisticians and data scientists continue to respond to life sciences organizations' needs," said Seema Verma, executive vice president and general manager, Oracle Health and Life Sciences. "With Empirica Signal we have now expanded data mining across even more safety databases to streamline the signaling process, improve workflows, and enable compliance."
More efficient data mining across databases
Multisource Signaling provides an efficient way to mine different proprietary and third-party safety databases, including Oracle Argus Safety, FDA FAERS or VAERS, WHO Vigibase, and now PMDA JADER. Results can then be reviewed side-by-side in Empirica's visual Signal Review module. This enables life sciences organizations to streamline their signaling processes, implement quality workflows with Empirica's Topics module, and helps them to achieve demonstrable Good Pharmacovigilance Practices (GVP) compliance in signal management.
While Empirica's sophisticated data mining engine provides frequentist, Bayesian, and the latest regression-enhanced (RGPS) algorithms (reducing false-positives and addressing masking1) for generating signals, the review process often requires the ability to easily drill down into important individual cases. With the new Versioned Case Series capability, Empirica allows users to capture and document single-case assessments over time without disrupting their existing signal review process.
Oracle Life Sciences Empirica is available standalone or as part of the Safety One Cloud suite for end-to-end pharmacovigilance. The AI-enabled Safety One suite incorporates automated case intake, management, and signaling together with the newest Oracle Analytics capabilities in a fully integrated, secure, and compliant cloud service. Built on the high performance and security of Oracle Cloud Infrastructure (OCI), Empirica Cloud and Safety One Cloud customers benefit from 24/7 global support, full infrastructure, platform and application management services, and regular cloud updates.
For more information about Oracle Life Sciences Empirica and Oracle Safety One Cloud Services, visit: https://www.oracle.com/safety
About Oracle Life Sciences
Oracle Life Sciences is a leader in cloud technology, pharmaceutical research, and consulting, trusted globally by professionals in both large and emerging companies engaged in clinical research and pharmacovigilance, throughout the therapeutic development lifecycle, including pre- and post-drug launch activities. With more than 20 years of experience, Oracle Life Sciences is committed to supporting clinical development and leveraging real-world evidence to deliver innovation and accelerate advancements – empowering the life sciences industry to improve patient outcomes. Learn more at oracle.com/lifesciences
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1 Harpaz, R., DuMouchel, W., Van Manen, R. et al. Signaling COVID-19 Vaccine Adverse Events. Drug Safety 45, 765–780 (2022). https://doi.org/10.1007/s40264-022-01186-z
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SOURCE Oracle
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