New Updates in Oracle Life Sciences Empirica Streamline Safety Signal Management Compliance in the Cloud
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
跨專有和公共安全數據庫的多源信號傳遞，包括JADER，支持複雜的數據挖掘和符合GVP的全球信號跟蹤。
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.
德克薩斯州奧斯汀，2024年12月2日 /PRNewswire/ -- 甲骨文今天宣佈對Oracle生命科學Empirica Signal和話題進行了新更新。Oracle市場領先的信號檢測和管理解決方案的最新版本擴展了全球安全監測的即用型數據庫選擇，並通過新增版本案例級註釋增強了信號審查過程，使用戶能夠深入到單個案例評估中。甲骨文繼續通過雲基礎建設、人工智能和擴展的真實世界數據能力推動精確的藥物監測。
"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."
「得益於甲骨文廣泛的技術和數據資源，我們的世界級統計學家和數據科學團隊將繼續滿足生命科學組織的需求，」甲骨文健康和生命科學的執行副總裁兼總經理Seema Verma說道。「通過Empirica Signal，我們現在已經擴大了在更多安全數據庫中的數據挖掘，以簡化信號處理，提高工作流程，並確保合規。」
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.
跨數據庫的更高效數據挖掘
多源信號提供了一種有效的方式來挖掘不同的專有和第三方安全數據庫，包括Oracle雅運股份安全、FDA FAERS或VAERS、WHO Vigibase，以及現在的PMDA JADER。結果可以在Empirica的可視信號審查模塊中並排審查。這使得生命科學組織能夠簡化其信號處理過程，實施與Empirica的特色板塊模塊結合的質量工作流程，幫助他們在信號管理中實現可證明的良好藥物監測實踐（GVP）合規性。
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.
儘管Empirica的複雜數據挖掘引擎提供了頻率、貝葉斯和最新的回歸增強(RGPS)算法(減少假陽性和解決屏蔽1)，用於生成信號，審查過程常常需要能夠輕鬆深入重要的單個案例。藉助新的版本案例系列功能，Empirica允許用戶隨着時間捕獲和記錄單個案例評估，而不會破壞其現有的信號審查過程。
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.
甲骨文生命科學Empirica可單獨使用，也可以作爲Safety One Cloud套件的一部分，用於端到端的藥物警戒。啓用人工智能的Safety One套件結合了自動化案例錄入、管理和信號檢測，以及最新的甲骨文分析能力，形成一個完全集成、安全和合規的雲服務。Empirica Cloud和Safety One Cloud客戶在甲骨文雲基礎建設（OCI）的高性能和安全性上獲益，享受24/7全球壓力位、全面的製造行業、平台和應用管理服務，以及定期的雲更新。
For more information about Oracle Life Sciences Empirica and Oracle Safety One Cloud Services, visit:
有關甲骨文生命科學Empirica和甲骨文Safety One雲服務的更多信息，請訪問：
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
關於甲骨文生命科學
甲骨文生命科學是雲科技、藥品研究和諮詢的領導者，在臨牀研究和藥物警戒領域受到全球大型和新興公司的專業人士的信任，貫穿於治療開發生命週期，包括藥物上市前後活動。憑藉超過20年的經驗，甲骨文生命科學致力於支持臨牀開發，利用真實世界證據推動創新和加速進展——賦能生命科學行業改善患者結果。了解更多信息，請訪問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 .
關於甲骨文
甲骨文提供集成的應用套件以及甲骨雲中的安全自主基礎設施。有關甲骨文(NYSE: ORCL)的更多信息，請訪問我們的網站。
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.
商標
甲骨文公司、Java、MySQL和NetSuite是甲骨文公司的註冊商標。NetSuite是第一家雲公司，開啓了雲計算的新紀元。
1 Harpaz, R., DuMouchel, W., Van Manen, R. et al. Signaling COVID-19 Vaccine Adverse Events. Drug Safety 45, 765–780 (2022).
Harpaz, R., DuMouchel, W., Van Manen, R.等人。COVID-19疫苗不良反應的信號。《藥物安全》2022年45卷，765-780頁。
SOURCE Oracle
來源 Oracle
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