{"id":84176,"date":"2025-05-14T22:24:14","date_gmt":"2025-05-14T20:24:14","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?p=84176"},"modified":"2026-07-01T01:32:42","modified_gmt":"2026-06-30T23:32:42","slug":"bring-safety-in-house-for-better-oversight-simplified-operational-reporting-and-cro-flexibility","status":"publish","type":"post","link":"https:\/\/www.veeva.com\/eu\/blog\/bring-safety-in-house-for-better-oversight-simplified-operational-reporting-and-cro-flexibility\/","title":{"rendered":"Bring Safety In-house for Better Oversight, Simplified Operational Reporting, and CRO Flexibility"},"content":{"rendered":"<style>\n.veeva-2024 .content-block__content blockquote {\nbackground: #fff;\nborder: 0;\nborder-left: 3px solid #f7981d;\ncolor: #01040b;\ndisplay: flex;\nflex-direction: column;\nfont-family: Poppins,sans-serif;\nfont-size: 18px;\nfont-weight: 600;\nletter-spacing: -.03em;\nline-height: 1.2;\nline-height: 1.4;\nmargin: 3.2rem 0;\noverflow: hidden;\npadding: 3.2rem 3.2rem 3.2rem 2.4rem;\ntext-align: left;\ntext-transform: unset;\n}\n<\/style>\n<p>\nThis edition of ³Ô¹Ï±¬ÁÏ\u2019s Safety Newsletter shares how to achieve greater CRO collaboration and better pharmacovigilance (PV) oversight with easier operational reporting.\n<\/p>\n<h2>Efficient PV Operations with Hybrid Outsourcing Model<\/h2>\n<p>\nManaging safety vendors with limited resources and evolving regulations is challenging for emerging or small biotechs. <a href=\"https:\/\/www.contractpharma.com\/exclusives\/emerging-trends-the-state-of-pharmacovigilance-outsourcing-in-clinical-development\/\" target=\"_blank\" rel=\"noreferrer noopener\">Research shows 49% of biotech companies<\/a> outsource to at least three vendors, and 11% outsource to five or more.\n<\/p>\n<p>\nGrowing scrutiny from regulators on outsourcing processes, data integrity, and adequate oversight to ensure safety reporting and monitoring remain high-quality and compliant is increasing the workload for PV teams.\n<\/p>\n<h2>Bringing Safety In-house to Overcome Outsourcing Challenges<\/h2>\n<p>\nPharmacovigilance (PV) teams gain greater control and have direct oversight and outsourcing flexibility by bringing a safety system in-house.  They can continue to leverage vendors for case processing and other PV activities, while experiencing many other benefits including:<\/p>\n<ul>\n<li><strong>Improved data quality and safety outputs:<\/strong> Real-time reports and dashboards tracking case processing time, case quality, and regulatory reporting compliance.<\/li>\n<li><strong>BPO flexibility:<\/strong> Change CROs or work with multiple vendors without disrupting safety operations, as safety data is owned and controlled by the sponsor.<\/li>\n<li><strong>Accelerated case processing:<\/strong> One end-to-end global case processing solution from intake to submissions with rule-based or manual case distribution.<\/li>\n<li><strong>Streamlined and automated processes:<\/strong> Seamlessly connect ³Ô¹Ï±¬ÁÏ Safety to ³Ô¹Ï±¬ÁÏ EDC, ³Ô¹Ï±¬ÁÏ eTMF, ³Ô¹Ï±¬ÁÏ RIM, and ³Ô¹Ï±¬ÁÏ MedInquiry to automate AE intake and other safety processes and synchronize information such as product and study data.<\/li>\n<li><strong>Easily scale safety:<\/strong> From a study to commercialization, mitigate compliance risks and have confidence in your trial data.<\/li>\n<\/ul>\n<p><img decoding=\"async\" class=\"img-left d-inline d-sm-inline\" style=\"border-radius:15px\" alt=\"\" src=\"\/wp-content\/uploads\/2025\/05\/April-Safety-Newsletter_Graphic_Vault-Safety-Dashboard.png\"><\/p>\n<div style=\"max-width:400px;float:left;margin:0 auto\">\n<h2 style=\"padding-top:20px;padding-bottom:10px;\">Simplify Safety Operational and Compliance Reporting with ³Ô¹Ï±¬ÁÏ Safety<\/h2>\n<p>\n<em>27 minutes<\/em><br \/>\n<a href=\"https:\/\/veevaconnect.com\/communities\/ALSAP72p0AA\/posts\/A5b-XGvRYAA\" target=\"_blank\" rel=\"noreferrer noopener\">Pharmacovigilance Director shares<\/a> how the safety team leveraged flexible reports and dashboards for better oversight and compliance.\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\" style=\"border-radius:15px\" alt=\"\" src=\"\/wp-content\/uploads\/2025\/05\/April-Safety-Newsletter_Graphic_Vault-Safety-Dashboard-Video.png\"><\/p>\n<div style=\"max-width:400px;float:left;margin:0 auto\">\n<h2 style=\"padding-top:20px\">Real-Time Oversight and Operational Efficiency with In-house Safety Solution<\/h2>\n<p>\n<em>5 minutes<\/em><br \/>\n<a href=\"https:\/\/www.veeva.com\/resources\/real-time-oversight-and-operational-efficiency-with-in-house-safety-solution\/\">See how CROs can collaborate<\/a> in a sponsor\u2019s safety system to create dashboards and operational reports for better data insights. Explore how ³Ô¹Ï±¬ÁÏ Safety centralizes safety data and automates case processing.\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\" style=\"border-radius:15px\" alt=\"\" src=\"\/wp-content\/uploads\/2025\/05\/April-Safety-Newsletter_Graphic_Bonne-Adams_Inhibrx.png\"><\/p>\n<div style=\"max-width:400px;float:left;margin:0 auto\">\n<h2 style=\"padding-top:20px\">Bring Safety System In-house: Direct Oversight and Control While Gaining CRO Flexibility<\/h2>\n<p><\/br><\/p>\n<p>\n<em>2 minutes<\/em><br \/>\n<a href=\"https:\/\/www.veeva.com\/customer-stories\/bring-safety-system-in-house-direct-oversight-and-control-while-gaining-cro-flexibility\/\">Hear how Inhibrx<\/a> brought a safety system in-house for direct oversight and control while gaining CRO flexibility.\n<\/p>\n<\/div>\n<div style=\"margin:20px 0\" class=\"clearfix\"><\/div>\n<blockquote><p>\n\u201cWe wanted to have our own global safety database so that we could see data in real-time, but still be able to partner with CROs because we are a small company\u201d<br \/>\n<span>&#8211; Bonne Adams, Vice President Operations, Inhibrx Biosciences, Inc.<\/span>\n<\/p><\/blockquote>\n<p>To learn more, visit <a href=\"\/eu\/products\/safety-newsletter\/\">Safety newsletters<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This edition of ³Ô¹Ï±¬ÁÏ\u2019s Safety Newsletter shares how to achieve greater CRO collaboration and better pharmacovigilance (PV) oversight with easier operational reporting.<\/p>\n","protected":false},"author":80,"featured_media":85441,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"product":[1022],"area":[977],"coauthors":[1544,1545],"class_list":["post-84176","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","product-safety","area-safety"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/posts\/84176"}],"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\/80"}],"replies":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/comments?post=84176"}],"version-history":[{"count":17,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/posts\/84176\/revisions"}],"predecessor-version":[{"id":96975,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/posts\/84176\/revisions\/96975"}],"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=84176"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/categories?post=84176"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/tags?post=84176"},{"taxonomy":"product","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/product?post=84176"},{"taxonomy":"area","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/area?post=84176"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/coauthors?post=84176"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}