{"id":95027,"date":"2026-03-06T17:22:17","date_gmt":"2026-03-06T16:22:17","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?post_type=resources&#038;p=95027"},"modified":"2026-03-11T15:16:01","modified_gmt":"2026-03-11T14:16:01","slug":"veeva-safety-signal-feature-brief","status":"publish","type":"resources","link":"https:\/\/www.veeva.com\/eu\/resources\/veeva-safety-signal-feature-brief\/","title":{"rendered":"³Ô¹Ï±¬ÁÏ Safety Signal"},"content":{"rendered":"<style>\n.veeva-2024 .fa-ul li p {\nmargin-top:5px;\n}\n.veeva-2024 .content-block .fa-check-circle {\ncolor: #f7981d;\nfont-weight: 400;\nfont-size:20px;\n}\n@media (min-width:768px) {\n.veeva-2024 .hero-centered {\npadding: 100px 0;\n}\n}\n@media (min-width:992px) {\n.veeva-2024 .content-block {\nmargin-top: 6rem;\n}\n}\n.veeva-2024 .content-block__sidebar {\ndisplay:none;\n}<\/p>\n<p>.veeva-2024 .content-block__content .stat-box {\nbackground: #eef1f5;\ndisplay: inline-block;\npadding: 10px 30px;\nborder-radius: 16px;\nfont-size: 18px;\nmargin: 5px 5px 20px 5px;\nfont-weight: 500;\n}\n.veeva-2024 .content-block__content .stat-box span {\ncolor:#f5670e;\nfont-weight:600;\n}\n\/* to remove the mobile dropdown *\/\n.veeva-2024 .form-dropdown {\ndisplay: none;\n}\n<\/style>\n<p><img decoding=\"async\" class=\"img-right d-none d-lg-block\" alt=\"\" src=\"\/wp-content\/uploads\/2026\/03\/Signal-Hero-Image.png\"><\/p>\n<h2>Seamlessly Manage Signals from Detection through Evaluation<\/h2>\n<p><img decoding=\"async\" class=\"img-right d-block d-lg-none\" alt=\"\" src=\"\/wp-content\/uploads\/2026\/03\/Signal-Hero-Image.png\"><\/p>\n<p>³Ô¹Ï±¬ÁÏ Safety Signal provides signal detection, analysis, and management. Automate or perform ad hoc analysis using industry-standard methods on ³Ô¹Ï±¬ÁÏ Safety case data and common data sources such as FAERS, VAERS, and EVDAS.<\/p>\n<p>With automatic daily transfer of safety data from ³Ô¹Ï±¬ÁÏ Safety to ³Ô¹Ï±¬ÁÏ Safety Signal, safety teams eliminate complex ETL processes while gaining faster and more reliable insights. ³Ô¹Ï±¬ÁÏ Safety Signal is part of ³Ô¹Ï±¬ÁÏ Safety, operating as a unified safety solution on a single cloud platform to maximize operational efficiencies and improve patient safety. <\/p>\n<h2>Key Business Benefits<\/h2>\n<ul class=\"fa-ul\">\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n   <strong>Faster Signal Detection<\/strong><\/p>\n<p>Accelerate signal identification with automated analysis and flexibility to start signal review\u2014in parallel\u2014during case processing.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n  <strong>Greater Business Alignment<\/strong><\/p>\n<p>Configurable workflows to align signal management with business processes while meeting compliance requirements.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n   <strong>Streamlined Compliance<\/strong><\/p>\n<p>Full visibility and traceability from signal identification to  recommended actions and outcome tracking.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n   <strong>End-to-end Signal Management<\/strong><\/p>\n<p>Manage signals from detection through evaluation with integrated documentation management for investigations.<\/p>\n<\/li>\n<\/ul>\n<h2>Features<\/h2>\n<ul class=\"fa-ul\">\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n   <strong>Daily Data Refresh<\/strong><\/p>\n<p>All ³Ô¹Ï±¬ÁÏ Safety data, including all case versions, is automatically imported nightly into ³Ô¹Ï±¬ÁÏ Safety Signal and shares a common data model.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n   <strong>Powerful OLAP Database<\/strong><\/p>\n<p>A high-performance database optimized for complex queries on billions of rows, enabling faster and more efficient execution of detailed queries and calculations.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n   <strong>Data Sources<\/strong><\/p>\n<p>Automatically brings together data and de-duplicates adverse events from multiple sources including  FAERS, VAERS,  EVDAS, and ³Ô¹Ï±¬ÁÏ Safety.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n   <strong>Flexible Calculations<\/strong><\/p>\n<p>Out-of-the-box disproportionality calculations, such as EBGM with stratification, and case counts with fully configurable filtering. Perform calculations at MedDRA PT level or MedDRA Query level and create advanced subgroups. New calculations with results permanently can be stored in ³Ô¹Ï±¬ÁÏ Safety.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n   <strong>Alerts<\/strong><\/p>\n<p>Initiate and configure business rules to automatically identify potential signals based on the results of calculations.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n   <strong>Case Series<\/strong><\/p>\n<p>Drill down into a case series behind each Signal Calculation to explore the case series in ³Ô¹Ï±¬ÁÏ Safety Workbench Dashboards and ³Ô¹Ï±¬ÁÏ Safety Workbench Reports.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n   <strong>Configurable Workflows<\/strong><\/p>\n<p>Easily configure workflows to align with your business processes, automatically routing signal management activities or recommended mitigation actions to a specific person or team. Manage EMA GVP Module IX compliance.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n   <strong>Unified with ³Ô¹Ï±¬ÁÏ Safety<\/strong><\/p>\n<p>Directly integrate signal individual case reviews into safety case processing to create a unified signal detection process.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n   <strong>Integrated Documentation Management<\/strong><\/p>\n<p>Seamlessly document signal-related activities, such as investigations, for traceability and to reduce risk and improve inspection-readiness.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n   <strong>Application Validation<\/strong><\/p>\n<p>All elements of infrastructure qualification (IQ) and operational qualification (OQ) are performed and documented for each major release. A sandbox\/test environment and user acceptance testing (UAT) scripts are also provided that can be leveraged and adapted for performance qualification (PQ).<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n   <strong>Part of ³Ô¹Ï±¬ÁÏ Development Cloud<\/strong><\/p>\n<p>A single cloud platform for safety, clinical, regulatory, and quality eliminates silos and drives end-to-end safety processes.<\/p>\n<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>³Ô¹Ï±¬ÁÏ Safety Signal provides signal detection, analysis, and management.<\/p>\n","protected":false},"featured_media":95028,"parent":0,"template":"","class_list":["post-95027","resources","type-resources","status-publish","has-post-thumbnail","hentry","resource-area-20-safety","resource-product-20-safety-signal","resource-type-product-briefs","region-eu"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/95027"}],"collection":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources"}],"about":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/types\/resources"}],"version-history":[{"count":0,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/95027\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/95028"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=95027"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}