New Updates in Oracle Life Sciences Empirica Streamline Safety Signal Management Compliance in the Cloud

Multisource signaling across proprietary and public safety databases, including JADER, enables sophisticated data mining and GVP-compliant signal tracking globally

AUSTIN, Texas, Dec. 2, 2024 /PRNewswire/ — Oracle today announced new updates to Oracle Life Sciences Empirica Signal and Topics. The latest release of Oracle’s market-leading signal detection and management solution extends out-of-the-box database choices for global safety monitoring and enhances the signal review process with versioned case-level annotation that enables users to drill into single-case assessments. Oracle continues to advance precision pharmacovigilance through cloud-based technologies, AI, and an expanding suite of real-world data capabilities.

“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

About Oracle
Oracle offers integrated suites of applications plus secure, autonomous infrastructure in the Oracle Cloud. For more information about Oracle (NYSE: ORCL), please visit us at www.oracle.com.

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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