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. 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.
Oracle ha annunciato aggiornamenti alla sua piattaforma Life Sciences Empirica Signal and Topics, migliorando le capacità di rilevamento e gestione dei segnali di sicurezza a livello globale. Il nuovo rilascio amplia le scelte di database per il monitoraggio della sicurezza e introduce l'annotazione a livello di caso versionata per valutazioni dettagliate di singoli casi. La piattaforma ora offre Segnalazione Multisource attraverso vari database di sicurezza, tra cui Oracle Argus Safety, FDA FAERS, VAERS, WHO Vigibase e PMDA JADER. Il sistema presenta avanzate capacità di data mining con algoritmi frequentisti, bayesiani e migliorati mediante regressione per ridurre i falsi positivi.
Oracle ha anunciado actualizaciones para su plataforma Life Sciences Empirica Signal and Topics, mejorando las capacidades de detección y gestión de señales de seguridad a nivel global. El nuevo lanzamiento amplía las opciones de bases de datos para el monitoreo de seguridad e introduce la anotación de casos a nivel de versión para evaluaciones detalladas de casos individuales. La plataforma ahora ofrece Señalización Multisource a través de varias bases de datos de seguridad, incluyendo Oracle Argus Safety, FDA FAERS, VAERS, WHO Vigibase y PMDA JADER. El sistema cuenta con avanzadas capacidades de minería de datos con algoritmos frequentistas, bayesianos y mejorados por regresión para reducir los falsos positivos.
오라클은 생명과학 엠피리카 신호 및 주제 플랫폼에 대한 업데이트를 발표하여 전 세계 안전 신호 감지 및 관리 기능을 향상시켰습니다. 새 릴리스는 안전 모니터링을 위한 데이터베이스 선택의 폭을 확대하고, 상세한 단일 사례 평가를 위한 버전 관리된 사례 수준 주석을 도입합니다. 이 플랫폼은 이제 Oracle Argus Safety, FDA FAERS, VAERS, WHO Vigibase 및 PMDA JADER를 포함한 다양한 안전 데이터베이스에서 다중 출처 신호화를 제공합니다. 이 시스템은 잘못된 긍정 반응을 줄이기 위해 빈도주의, 베이지안, 회귀 강화 알고리즘을 가진 고급 데이터 마이닝 기능을 특징으로 합니다.
Oracle a annoncé des mises à jour de sa plateforme Life Sciences Empirica Signal and Topics, améliorant les capacités de détection et de gestion des signaux de sécurité au niveau mondial. La nouvelle version élargit les choix de bases de données pour le suivi de la sécurité et introduit une annotation de cas par version pour des évaluations détaillées des cas individuels. La plateforme propose désormais une Signalisation Multisource à travers diverses bases de données de sécurité, y compris Oracle Argus Safety, FDA FAERS, VAERS, WHO Vigibase et PMDA JADER. Le système présente des capacités avancées d'exploration de données avec des algorithmes fréquentistes, bayésiens et améliorés par régression pour réduire les faux positifs.
Oracle hat Updates für seine Plattform Life Sciences Empirica Signal and Topics angekündigt, die die globalen Fähigkeiten zur Erkennung und Verwaltung von Sicherheitsmeldungen verbessern. Das neue Release erweitert die Auswahl an Datenbanken für die Sicherheitsüberwachung und führt versionierte Fallanmerkungen für detaillierte Einzelbewertungen ein. Die Plattform bietet nun Multisource Signaling über verschiedene Sicherheitsdatenbanken hinweg, einschließlich Oracle Argus Safety, FDA FAERS, VAERS, WHO Vigibase und PMDA JADER. Das System verfügt über fortschrittliche Datenmining-Fähigkeiten mit frequentistischen, bayesianischen und regressionsverbesserten Algorithmen zur Reduzierung von Fehlalarmen.
- 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
- None.
Insights
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
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
"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
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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
FAQ
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