{"id":4709,"date":"2019-10-03T17:02:13","date_gmt":"2019-10-03T17:02:13","guid":{"rendered":"https:\/\/live-ubc-llc.pantheonsite.io\/?p=649"},"modified":"2025-08-15T14:21:38","modified_gmt":"2025-08-15T14:21:38","slug":"are-you-ready-for-sentinel","status":"publish","type":"insights","link":"https:\/\/ubc.com\/insights\/are-you-ready-for-sentinel\/","title":{"rendered":"Are You Ready For Sentinel? | New RWE Safety Initiative"},"content":{"rendered":"\n<p><strong>FDA Continues to Support the Sentinel Initiative<\/strong><\/p>\n\n\n\n<p>An October 1 announcement of FDA\u2019s <a href=\"https:\/\/www.populationmedicine.org\/news-media\/harvard-pilgrim-health-care-institute-funded-220-million-next-phase-fda-sentinel-0\" target=\"_blank\" rel=\"noreferrer noopener\">funding<\/a> of $220 Million to the Harvard Pilgrim Health Care Institute for the next phase of FDA\u2019s <a href=\"https:\/\/www.sentinelinitiative.org\/\" target=\"_blank\" rel=\"noreferrer noopener\">Sentinel System<\/a> brings continued focus on FDA\u2019s commitment to evaluating Real World Evidence (RWE) for informing prescribers and patients about product safety.\u00a0Key to the Sentinel System is a network of electronic medical records that can be utilized rapidly to address issues of concern.<\/p>\n\n\n\n<p>UBC has been at the forefront of the <a href=\"https:\/\/ubc.com\/solution\/evidence-development\/modernized-study-design-execution\/\" target=\"_blank\" rel=\"noreferrer noopener\">R<\/a><a href=\"https:\/\/ubc.com\/solution\/evidence-development\/\" target=\"_blank\" rel=\"noreferrer noopener\">WE <\/a>arena for the past 15 years and has developed methodological depth as well as automated tools that generate rapid insights from real world claims and EMR databases.&nbsp;The key to validated, automated evaluation and response is our <a href=\"https:\/\/ubc.com\/solution\/evidence-development\/modernized-study-design-execution\/\" target=\"_blank\" rel=\"noreferrer noopener\">S\u1d01fetyWorks<sup>\u00ae<\/sup><\/a> tool that allows for analysis without programming. Our comprehensive solution includes:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Global Database Feasibility Studies<\/strong>\n<ul class=\"wp-block-list\">\n<li>&nbsp;&nbsp;In-depth review of data elements and literature<\/li>\n\n\n\n<li>Understanding data strengths and limitations<\/li>\n\n\n\n<li>&nbsp;Direct discussions with data vendors<\/li>\n\n\n\n<li>Data agnostic &#8211; recommendations based on database \u2018fit for purpose\u2019<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Protocol Development &#8211; Designing Post-Marketing Safety Studies<\/strong>\n<ul class=\"wp-block-list\">\n<li>&nbsp;Cumulatively, over 100 years of experience developing the appropriate study design to provide meaningful results<\/li>\n\n\n\n<li>Proven track record of developing protocols accepted by the EMA and FDA<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Study Implementation<\/strong>\n<ul class=\"wp-block-list\">\n<li>Customized studies and\/or automated analytics according to the approved study protocol<\/li>\n\n\n\n<li>Established relationships with US and European data vendors<\/li>\n\n\n\n<li>Use of formal SOPs for study conduct and validation of results<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>RWD automated software for signal identification and refinement<\/strong>\n<ul class=\"wp-block-list\">\n<li>S\u00c6fetyWorks\u00ae analytics software leverages RWD for performing signal <em>refinement<\/em> and <em>evaluation<\/em> to supplement signal identification based on spontaneous case reports.<\/li>\n\n\n\n<li>Aligned with FDA\u2019s Sentinel Initiative methods of signal identification and evaluation.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p>Take steps now to partner with a patient-support services company with extensive RWE safety experience including in signal detection and analyses. <a href=\"https:\/\/ubc.com\/contact-us\/\" target=\"_blank\" rel=\"noreferrer noopener\">Contact UBC<\/a> to see if you are positioned for Sentinel and to learn more.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>With continued investment in the RWE space, find out how to meet the needs of regulators, payers, and prescribers.<\/p>\n","protected":false},"featured_media":10685,"parent":0,"menu_order":0,"comment_status":"open","ping_status":"open","template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"insights_category":[33],"insights_tags":[107,108,109,110,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,106,135,136,137,138,139,140,141,142],"class_list":["post-4709","insights","type-insights","status-publish","format-standard","has-post-thumbnail","hentry","insights_category-blog","insights_tags-anesthesiology","insights_tags-cardiology","insights_tags-dental-and-oral-health","insights_tags-dermatology","insights_tags-gastroenterology","insights_tags-genetic-diseases","insights_tags-gynecology","insights_tags-hematology","insights_tags-hepatology","insights_tags-immunology","insights_tags-infectious-diseases","insights_tags-medical-devices","insights_tags-mens-health","insights_tags-metabolic-diseases","insights_tags-musculoskeletal","insights_tags-nephrology","insights_tags-neurology","insights_tags-obstetrics","insights_tags-oncology","insights_tags-ophthalmology","insights_tags-orthopedics-orthopedic-surgery","insights_tags-otolaryngology","insights_tags-pain","insights_tags-palliative-care","insights_tags-pediatrics-neonatology","insights_tags-podiatry","insights_tags-psychiatry","insights_tags-pulmonary-respiratory-diseases","insights_tags-rare-and-orphan-diseases","insights_tags-rheumatology","insights_tags-sleep-disorders","insights_tags-surgery","insights_tags-transplantation","insights_tags-trauma","insights_tags-urology","insights_tags-vascular-diseases"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v26.1.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Are You Ready For Sentinel? 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