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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/new-updates-in-oracle-life-sciences-empirica-streamline-safety-signal-management-compliance-in-the-cloud-302317058.html
SOURCE Oracle