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
跨专有和公共安全数据库（包括JADER）的多源信号可在全球范围内进行复杂的数据挖掘和符合GVP的信号跟踪
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.
德克萨斯州奥斯汀，2024年12月2日 /PRNewswire/ — 甲骨文今天宣布了对甲骨文生命科学Empirica Signal and Topics的新更新。Oracle 市场领先的信号检测和管理解决方案的最新版本扩展了全球安全监控的开箱即用数据库选择，并通过版本化案例级注释增强了信号审查流程，使用户能够深入研究单一案例评估。甲骨文继续通过基于云的技术、人工智能和不断扩大的现实世界数据功能套件来推进精准药物警戒的发展。
"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."
甲骨文健康与生命科学执行副总裁兼总经理西玛·维尔玛表示：“在甲骨文丰富的技术和数据资源的支持下，我们世界一流的统计学家和数据科学家团队继续响应生命科学组织的需求。”“借助 Empirica Signal，我们现在已将数据挖掘扩展到更多安全数据库，以简化信令流程、改善工作流程并实现合规性。”
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.
更高效地跨数据库进行数据挖掘
多源信号为挖掘不同的专有和第三方安全数据库提供了一种有效的方法，包括甲骨文阿格斯安全数据库、美国食品药品管理局FAERS或VAERS、世卫组织Vigibase以及现在的PMDA JADER。然后，可以在Empirica的可视化信号查看模块中并排查看结果。这使生命科学组织能够简化其信号传导流程，使用Empirica的主题模块实施质量工作流程，并帮助他们在信号管理中实现明显的良好药物警戒规范（GVP）合规性。
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.
尽管Empirica复杂的数据挖掘引擎为生成信号提供了频率主义、贝叶斯算法和最新的回归增强（RGPS）算法（减少误报和寻址掩码1），但审查过程通常需要能够轻松地深入研究重要的个案。凭借新的版本化案例系列功能，Empirica允许用户捕获和记录一段时间内的单个案例评估，而不会中断其现有的信号审查流程。
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.
Oracle 生命科学 Empirica 可单独使用，也可以作为端到端药物警戒的 Safety One 云套件的一部分使用。支持人工智能的 Safety One 套件在完全集成、安全和合规的云服务中整合了自动案例受理、管理和信号以及最新的 Oracle 分析功能。Empirica Cloud 和 Safety One Cloud 的客户建立在 Oracle 云基础架构 (OCI) 的高性能和安全性之上，受益于全天候全球支持、完整的基础架构、平台和应用程序管理服务以及定期的云更新。
For more information about Oracle Life Sciences Empirica and Oracle Safety One Cloud Services, visit:
有关甲骨文生命科学 Empirica 和 Oracle Safety One 云服务的更多信息，请访问：
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
关于甲骨文生命科学
Oracle Life Sciences 是云技术、药物研究和咨询领域的领导者，在整个治疗开发生命周期，包括药物上市前后活动，都受到从事临床研究和药物警戒的大型和新兴公司的专业人员的信赖。Oracle Life Sciences 拥有 20 多年的经验，致力于支持临床开发并利用现实世界的证据来实现创新和加速进步，从而帮助生命科学行业改善患者预后。要了解更多信息，请访问 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 .
关于甲骨文
Oracle 在 Oracle 云中提供集成的应用程序套件以及安全、自主的基础设施。有关甲骨文（纽约证券交易所代码：ORCL）的更多信息，请访问我们的网站。
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.
商标
甲骨文、Java、MySQL 和 NetSuite 是甲骨文公司的注册商标。NetSuite是第一家云公司，开创了云计算的新时代。
1 Harpaz, R., DuMouchel, W., Van Manen, R. et al. Signaling COVID-19 Vaccine Adverse Events. Drug Safety 45, 765–780 (2022).
1 Harpaz、R.、DuMouchel、W.、Van Manen、R. 等发出信号 COVID-19 疫苗不良事件。药物安全 45、765—780（2022）。
SOURCE Oracle
来源 Oracle
