{"id":13849,"date":"2026-04-01T10:47:00","date_gmt":"2026-04-01T10:47:00","guid":{"rendered":"https:\/\/intuceo.com\/?post_type=use-case&#038;p=13849"},"modified":"2026-09-03T09:48:10","modified_gmt":"2026-09-03T09:48:10","slug":"automating-adverse-event-detection-with-ai-ml","status":"publish","type":"use-case","link":"https:\/\/puffertech.com\/clients\/intuceo\/case-studies\/automating-adverse-event-detection-with-ai-ml\/","title":{"rendered":"Automating Adverse Event detection with AI\/ML eliminating manual efforts and aiding to timely FDA submittals."},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"13849\" class=\"elementor elementor-13849\" data-elementor-post-type=\"use-case\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0eae61d e-flex e-con-boxed e-con e-parent\" data-id=\"0eae61d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-6336a90 e-con-full e-flex e-con e-child\" data-id=\"6336a90\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ba8dcbb elementor-widget elementor-widget-image\" data-id=\"ba8dcbb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"223\" height=\"216\" src=\"https:\/\/puffertech.com\/clients\/intuceo\/wp-content\/uploads\/2026\/04\/1-e1784609109390.jpg\" class=\"attachment-full size-full wp-image-18588\" alt=\"\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d216b4e e-con-full e-flex e-con e-child\" data-id=\"d216b4e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-83bbb13 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"83bbb13\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\tThe current system of identifying adverse events from customer complaints is labor intensive and time consuming. FDA guidelines require health care providers and manufacturers to submit voluntary reports of adverse events associated with products within the 15 days of compliant. However, the challenge companies face is to swift through the massive volumes of the complaints and require highly trained professionals to review, validate and\nidentify the adverse event to prepare report in timely fashion (<15 days of\ncomplaint) for FDA submittal.\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-8c0366e e-flex e-con-boxed e-con e-parent\" data-id=\"8c0366e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-743a8b8 e-con-full e-flex e-con e-child\" data-id=\"743a8b8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5bce8d8 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"5bce8d8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Goal<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-26ac951 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"26ac951\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\tA fortune 100 big pharma\/MD&#038;D client approached Intuceo\u00ae team to automate and improve\nthe process efficiency leveraging AI\/ML. Applying AI effectively to determine whether a complaint is\npotentially an adverse event or not requires not only base level prediction capability but also ability\nof the AI model to rationalize its prediction. A Yes\/No decision of AI model may help in reducing the\nvolume of complaints, but it doesn\u2019t eliminate the pains takingly time-consuming efforts from experts\nin manually annotating the explanation to why that Event is Adverse Event or not. While most AI\ncognitive models provide base level Prediction capabilities, they seldom come with \u201cExplainable AI\nintelligence\u201d. Intuceo\u00ae team of experts along with patented Intuceo\u00ae auto ml tools for pattern\nrecognition and predictive models, partnered with the client and implemented a AI\/ML solution that\naccomplished both the goals, \u201cAccurately Identify potential Adverse Event\u201d along with rationale on\nWHY with the explainable AI feature. \t\t\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4107452 e-con-full e-flex e-con e-child\" data-id=\"4107452\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-245fa23 e-con-full e-flex e-con e-child\" data-id=\"245fa23\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-76a1877 elementor-widget__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"76a1877\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 136.967-111.033 248-248 248S8 392.967 8 256 119.033 8 256 8s248 111.033 248 248zM227.314 387.314l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.249-16.379-6.249-22.628 0L216 308.118l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.249 16.379 6.249 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Any adverse event is reportable to FDA if the event: Is fatal, is life-threatening, is permanently or significantly disabling, Requires or prolongs hospitalization, Causes a congenital anomaly <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 136.967-111.033 248-248 248S8 392.967 8 256 119.033 8 256 8s248 111.033 248 248zM227.314 387.314l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.249-16.379-6.249-22.628 0L216 308.118l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.249 16.379 6.249 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">These adverse events must be reported to FDA as soon as possible but no later than within 15 calendar days following the initial receipt of the information<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d5ae860 e-con-full e-flex e-con e-child\" data-id=\"d5ae860\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-34db675 elementor-widget elementor-widget-image\" data-id=\"34db675\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1003\" height=\"466\" src=\"https:\/\/puffertech.com\/clients\/intuceo\/wp-content\/uploads\/2026\/04\/2.png\" class=\"attachment-full size-full wp-image-18589\" alt=\"\" srcset=\"https:\/\/puffertech.com\/clients\/intuceo\/wp-content\/uploads\/2026\/04\/2.png 1003w, https:\/\/puffertech.com\/clients\/intuceo\/wp-content\/uploads\/2026\/04\/2-300x139.png 300w, https:\/\/puffertech.com\/clients\/intuceo\/wp-content\/uploads\/2026\/04\/2-768x357.png 768w\" sizes=\"(max-width: 1003px) 100vw, 1003px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-982e634 e-con-full e-flex e-con e-child\" data-id=\"982e634\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4265ab1 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"4265ab1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Click the Download button to get the CaseStudy<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0d0accd elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"0d0accd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\tHaving an AI\/ML driven solution with both AE detection along and effective explanation resulted in high through put to process more complains in given time window, significant reduction\nin expert professional\u2019s time and number, resulting in the timely FDA submittal.\t\t\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-8b05c3b e-con-full e-flex e-con e-child\" data-id=\"8b05c3b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-af44898 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"af44898\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/245228077.fs1.hubspotusercontent-na2.net\/hubfs\/245228077\/Case%20Study%20Documents\/CS%20-%20AIML%20eliminating%20manual%20efforts%20and%20aiding%20to%20timely%20FDA%20submittals.pdf\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Download CaseStudy<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-8de355d elementor-hidden-desktop elementor-hidden-tablet elementor-hidden-mobile e-flex e-con-boxed e-con e-parent\" data-id=\"8de355d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-ae41c3f e-con-full e-flex e-con e-child\" data-id=\"ae41c3f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-02fd295 elementor-widget elementor-widget-heading\" data-id=\"02fd295\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Fill out the form below to Download the case study<\/h4>\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d6d58d0 e-con-full e-flex e-con e-child\" data-id=\"d6d58d0\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ab290b2 usecase-form elementor-widget elementor-widget-html\" data-id=\"ab290b2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t\t<script charset=\"utf-8\" 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elementor-size-default\">Results<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d9f15f2 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"d9f15f2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Having an AI\/ML driven solution with both AE detection along and effective explanation resulted in high through put to process more complains in given time window, significant reduction<br \/>in expert professional\u2019s time and number, resulting in the timely FDA submittal.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0a23ee1 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-widget elementor-widget-heading\" data-id=\"0a23ee1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Click the Download button to get the CaseStudy<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-522e435 e-con-full elementor-hidden-desktop elementor-hidden-tablet elementor-hidden-mobile e-flex e-con e-child\" data-id=\"522e435\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-768d016 elementor-align-center elementor-mobile-align-left elementor-widget elementor-widget-button\" data-id=\"768d016\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/puffertech.com\/clients\/intuceo\/contact-us\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Talk to our Experts<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"author":2,"featured_media":13065,"template":"","meta":{"_acf_changed":false},"categories":[156,10],"tags":[152],"class_list":["post-13849","use-case","type-use-case","status-publish","has-post-thumbnail","hentry","category-artificial-intelligence-case-studies","category-case-study","tag-life-science"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>AI\/ML Adverse Event Detection for FDA Submittals<\/title>\n<meta name=\"description\" content=\"Learn how Intuceo&#039;s AI\/ML solution automates adverse event detection, eliminates manual effort, and supports timely FDA submissions.\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" 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