{"id":85698,"date":"2025-07-09T20:22:48","date_gmt":"2025-07-09T18:22:48","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?p=85698"},"modified":"2026-02-16T16:18:31","modified_gmt":"2026-02-16T15:18:31","slug":"reduce-reconciliation-of-clinical-serious-adverse-events-sae","status":"publish","type":"post","link":"https:\/\/www.veeva.com\/eu\/blog\/reduce-reconciliation-of-clinical-serious-adverse-events-sae\/","title":{"rendered":"Reduce Reconciliation of Clinical<br> Serious Adverse Events (SAE)"},"content":{"rendered":"<p>\nThis edition of Veeva\u2019s Safety Newsletter spotlights the Safety-EDC Connection and how it automates the flow of serious adverse event (SAEs) records from data management teams to the safety inbox and reduces reconciliation.\n<\/p>\n<h2>Reducing high overhead for SAE case processing and reconciliation<\/h2>\n<p>\nClinical and safety teams collect and process data independently using separate databases, even though they manage common data elements. Reconciling adverse event (AE) data between the clinical study database and the safety database can require several weeks of effort, generate hundreds of queries to investigator sites, and potentially delay key regulatory submissions until the process is fully resolved.\n<\/p>\n<p>\nProcessing clinical SAEs by safety teams is estimated to take <a href=\"https:\/\/www.appliedclinicaltrialsonline.com\/view\/sae-rates-clinical-trials target=\"_blank\" rel=\"noreferrer noopener\">~2.15 FTE days\/SAE<\/a> in sponsor effort excluding site support. With study coordinators spending between <a href=\"https:\/\/www.appliedclinicaltrialsonline.com\/view\/burying-sites-under-safety-reporting\" target=\"_blank\" rel=\"noreferrer noopener\">10% and 20% of their total work effort<\/a> on AE\/SAE reporting, according to Tufts Center for the Study of Drug Development, streamlining SAE processing and reconciliation can reduce trial costs and risk of delays for achieving key milestones.\n<\/p>\n<h2>Automate sharing of clinical adverse event and casebook data with Safety-EDC Connection<\/h2>\n<p>\nSharing data across clinical and safety teams relies on manual duplicate data entry or expensive integrations. The Safety-EDC Connection enables:<\/p>\n<ul>\n<li><strong>More comprehensive data sharing than E2B integrations:<\/strong> Automate data intake of 200+ clinical subject reportable event fields and improve safety outputs.<\/li>\n<li><strong>Faster case processing and medical review:<\/strong> Safety teams have direct access to view and can add relevant subject data during case processing.<\/li>\n<li><strong>Greater efficiency to process and reconcile SAEs:<\/strong> More efficient case processing and streamlined reconciliation with direct linking of clinical SAE to safety case ID.<\/li>\n<li><strong>Automated data sync:<\/strong> Automatically transfer SAE casebook data to safety  (configured, includes non-E2B) and share safety case status with clinical.<\/li>\n<\/ul>\n<p><img decoding=\"async\" class=\"img-left d-inline d-sm-inline\" alt=\"\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2025\/07\/safety-newsletter-may-680x480-dashboard.png\"><\/p>\n<div style=\"max-width:400px;float:left;margin:0 auto\">\n<h2 style=\"padding-top:20px;padding-bottom:10px;\">Automate End-to-End Clinical Patient Safety for Improved Efficiency and Data Quality<\/h2>\n<p>\n<em>26 minutes<\/em><br \/>\n<a href=\"https:\/\/www.veeva.com\/eu\/resources\/automate-end-to-end-clinical-patient-safety-for-improved-efficiency-and-data-quality\/\">Safety experts share<\/a> how to automate information flow between clinical and safety teams to streamline case processing of SAEs and distribution of safety letters.\n<\/p>\n<\/div>\n<div style=\"margin:20px 0\" class=\"clearfix\"><\/div>\n<p><img decoding=\"async\" class=\"img-left d-inline d-sm-inline\" alt=\"\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2025\/07\/safety-newsletter-may-680x480-safety-edc.png\"><\/p>\n<div style=\"max-width:400px;float:left;margin:0 auto\">\n<h2 style=\"padding-top:20px\">Streamline Clinical Serious Adverse Event Reporting and Management<\/h2>\n<p>\n<em>4 minute read<\/em><br \/>\nExplore the <a href=\"https:\/\/www.veeva.com\/eu\/resources\/safety-edc-connection-features-brief\/\">Safety-EDC Connection feature brief<\/a> on how to automate clinical SAE reporting to safety, increase quality of PV data, and reduce reconciliation.\n<\/p>\n<\/div>\n<div style=\"margin:20px 0\" class=\"clearfix\"><\/div>\n<p><img decoding=\"async\" class=\"img-left d-inline d-sm-inline\" alt=\"\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2024\/11\/resource-tile-inhibrx-safety-video-bring-safety-system-in-house-340x240@2x.png\"><\/p>\n<div style=\"max-width:400px;float:left;margin:0 auto\">\n<h2 style=\"padding-top:20px\">Reduce Safety Case Processing Time by 50%<\/h2>\n<p><\/br><\/p>\n<p>\n<em>2 minutes<\/em><br \/>\n<a href=\"https:\/\/www.veeva.com\/eu\/customer-stories\/reducing-safety-case-processing-time-by-50\/\">Hear how Inhibrx<\/a> saves time and reduces reconciliation by connecting Veeva Safety with Veeva EDC.\n<\/p>\n<\/div>\n<div style=\"margin:20px 0\" class=\"clearfix\"><\/div>\n<blockquote><p>\n\u201cWe expect case processing time to go down by 50% and data accuracy and quality went up because you\u2019re not doing double data entry from Vault EDC to Vault Safety.\u201d<br \/>\n<span>&#8211; Bonne Adams, Vice President Operations, Inhibrx Biosciences, Inc.<\/span>\n<\/p><\/blockquote>\n<p>To read more, visit <a href=\"\/eu\/products\/safety-newsletter\/\">Safety newsletters<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This month\u2019s edition of Veeva\u2019s Safety Newsletter spotlights the Safety-EDC Connection and how it automates the flow of serious adverse event (SAEs) records from data management teams to the safety inbox and reduces reconciliation.<\/p>\n","protected":false},"author":419,"featured_media":85441,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"product":[],"area":[],"coauthors":[1544,1545],"class_list":["post-85698","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","blog-area-rd","blog-product-content-management"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/posts\/85698"}],"collection":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/users\/419"}],"replies":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/comments?post=85698"}],"version-history":[{"count":7,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/posts\/85698\/revisions"}],"predecessor-version":[{"id":94104,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/posts\/85698\/revisions\/94104"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/85441"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=85698"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/categories?post=85698"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/tags?post=85698"},{"taxonomy":"product","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/product?post=85698"},{"taxonomy":"area","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/area?post=85698"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/coauthors?post=85698"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}