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

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.

Insights

Tech Expert

The enhanced Oracle Life Sciences Empirica platform represents a significant advancement in pharmacovigilance technology. The multisource signaling capability across various safety databases (Argus Safety, FDA FAERS, WHO Vigibase, PMDA JADER) streamlines data mining and signal detection processes. The integration of advanced algorithms - frequentist, Bayesian and regression-enhanced RGPS - coupled with the new Versioned Case Series feature, strengthens Oracle's position in the $6 billion global pharmacovigilance market.

The platform's cloud-native architecture on OCI provides scalability and security advantages, while AI enablement and analytics capabilities position Oracle strategically in the growing precision medicine sector. For investors, this enhances Oracle's competitive moat in the healthcare vertical, particularly against competitors like Veeva Systems and ArisGlobal.

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.

Trademarks
Oracle, Java, MySQL and NetSuite are registered trademarks of Oracle Corporation. NetSuite was the first cloud company—ushering in the new era of cloud computing.

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

FAQ

What new features did Oracle (ORCL) add to Empirica Signal in December 2024?

Oracle added Multisource Signaling capabilities across more safety databases and introduced versioned case-level annotation for detailed single-case assessments.

Which databases does Oracle's (ORCL) Empirica Signal now support?

Empirica Signal now supports Oracle Argus Safety, FDA FAERS, VAERS, WHO Vigibase, and PMDA JADER databases.

How does Oracle (ORCL) Empirica Signal improve pharmacovigilance?

It uses AI-enabled technology, sophisticated data mining algorithms, and real-world data capabilities to streamline signal detection and management while ensuring GVP compliance.