{"id":52,"date":"2023-08-22T02:05:00","date_gmt":"2023-08-22T02:05:00","guid":{"rendered":"https:\/\/staging.vantagebiotrials.com\/?page_id=52"},"modified":"2026-06-15T17:58:11","modified_gmt":"2026-06-15T17:58:11","slug":"case-studies","status":"publish","type":"page","link":"https:\/\/vantagebiotrials.com\/fr\/case-studies\/","title":{"rendered":"Case Studies"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"52\" class=\"elementor elementor-52\">\n\t\t\t\t\t\t<div class=\"elementor-section elementor-top-section elementor-element elementor-element-8afe09e elementor-section-full_width elementor-section-stretched elementor-section-height-default elementor-section-height-default cms-remove-row-no cms-section-no-padding-no cms-full-content-with-space-none cms-boxed-bg-false cms-section-boxed-divider-false cms-overlay-gradient-bg-yes cms-overlay-gradient-mode-tb\" data-id=\"8afe09e\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;}\">\r\n\t\t\t<div class=\"cms-overlay-gradient\"><\/div><div class=\"cms-section-boxed-bg\"><\/div><div class=\"cms-section-boxed-divider\"><\/div><div class=\"cms-elementor-section-remove\"><\/div><div class=\"cms-elementor-section-corner cms-elementor-section-corner-top\"><\/div><div class=\"cms-elementor-section-corner cms-elementor-section-corner-bottom\"><\/div>\t\t\t<div class=\"elementor-container elementor-column-gap-no \" >\r\n\t\t\t        <div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-faa2601\" data-id=\"faa2601\" data-element_type=\"column\" data-e-type=\"column\">\r\n            <div class=\"elementor-widget-wrap elementor-element-populated\">\r\n                \t\t<div class=\"elementor-element elementor-element-0be1123 elementor-widget elementor-widget-slider_revolution\" data-id=\"0be1123\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"slider_revolution.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\n\t\t<div class=\"wp-block-themepunch-revslider\">\n\t\t\t<!-- START casestudies REVOLUTION SLIDER 6.7.18 --><p class=\"rs-p-wp-fix\"><\/p>\n\t\t\t<rs-module-wrap id=\"rev_slider_9_1_wrapper\" data-source=\"gallery\" style=\"visibility:hidden;background:transparent;padding:0;margin:0px auto;margin-top:0;margin-bottom:0;\">\n\t\t\t\t<rs-module id=\"rev_slider_9_1\" style=\"\" data-version=\"6.7.18\">\n\t\t\t\t\t<rs-slides style=\"overflow: hidden; position: absolute;\">\n\t\t\t\t\t\t<rs-slide style=\"position: absolute;\" data-key=\"rs-11\" data-title=\"Slide\" data-in=\"o:1;\" data-out=\"o:1;\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" src=\"\/\/vantagebiotrials.com\/wp-content\/plugins\/revslider\/sr6\/assets\/assets\/dummy.png\" alt=\"\" title=\"ThinkstockPhotos-sb10065850n-001.jpg\" width=\"2000\" height=\"1333\" class=\"rev-slidebg tp-rs-img rs-lazyload\" data-lazyload=\"\/\/vantagebiotrials.com\/wp-content\/uploads\/revslider\/case-studies-fr\/ThinkstockPhotos-sb10065850n-001.jpg\" data-parallax=\"5\" data-no-retina>\n<!--\n\t\t\t\t\t\t\t--><rs-layer\n\t\t\t\t\t\t\t\tid=\"slider-9-slide-11-layer-5\" \n\t\t\t\t\t\t\t\tdata-type=\"image\"\n\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\tdata-xy=\"x:-327px;y:-68px;\"\n\t\t\t\t\t\t\t\tdata-text=\"l:22;\"\n\t\t\t\t\t\t\t\tdata-dim=\"w:1348px;h:633px;\"\n\t\t\t\t\t\t\t\tdata-frame_0=\"tp:600;\"\n\t\t\t\t\t\t\t\tdata-frame_1=\"tp:600;e:power2.inOut;st:1410;\"\n\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;tp:600;e:nothing;st:w;\"\n\t\t\t\t\t\t\t\tstyle=\"z-index:5;\"\n\t\t\t\t\t\t\t><img decoding=\"async\" src=\"\/\/vantagebiotrials.com\/wp-content\/plugins\/revslider\/sr6\/assets\/assets\/dummy.png\" alt=\"\" class=\"tp-rs-img rs-lazyload\" width=\"1348\" height=\"633\" data-lazyload=\"\/\/vantagebiotrials.com\/wp-content\/uploads\/revslider\/slider-ihr-1\/cloud.png\" data-no-retina> \n\t\t\t\t\t\t\t<\/rs-layer><!--\n\n\t\t\t\t\t\t\t--><rs-layer\n\t\t\t\t\t\t\t\tid=\"slider-9-slide-11-layer-2\" \n\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\tdata-color=\"rgba(51,51,51,1)\"\n\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\tdata-xy=\"x:88px;y:162px;\"\n\t\t\t\t\t\t\t\tdata-text=\"s:40;l:40;fw:700;\"\n\t\t\t\t\t\t\t\tdata-frame_0=\"x:50px;tp:600;\"\n\t\t\t\t\t\t\t\tdata-frame_1=\"tp:600;e:easeOutExpo;st:700;sp:1000;\"\n\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;tp:600;e:nothing;st:w;\"\n\t\t\t\t\t\t\t\tstyle=\"z-index:6;font-family:'Poppins';text-transform:uppercase;\"\n\t\t\t\t\t\t\t>The Science of Accuracy. \n\t\t\t\t\t\t\t<\/rs-layer><!--\n\n\t\t\t\t\t\t\t--><rs-layer\n\t\t\t\t\t\t\t\tid=\"slider-9-slide-11-layer-3\" \n\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\tdata-color=\"rgba(51,51,51,1)\"\n\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\tdata-xy=\"x:87px;y:212px;\"\n\t\t\t\t\t\t\t\tdata-text=\"s:18;l:25;fw:700;\"\n\t\t\t\t\t\t\t\tdata-frame_0=\"y:50px;tp:600;\"\n\t\t\t\t\t\t\t\tdata-frame_1=\"tp:600;e:easeOutExpo;st:900;sp:700;\"\n\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;tp:600;e:nothing;st:w;\"\n\t\t\t\t\t\t\t\tstyle=\"z-index:7;font-family:'Lato';\"\n\t\t\t\t\t\t\t>\"The only source of knowledge is experience.\"<br \/>\n  - Albert Einstein \n\t\t\t\t\t\t\t<\/rs-layer><!--\n-->\t\t\t\t\t<\/rs-slide>\n\t\t\t\t\t<\/rs-slides>\n\t\t\t\t<\/rs-module>\n\t\t\t\t<script>\n\t\t\t\t\tsetREVStartSize({c: 'rev_slider_9_1',rl:[1240,1024,778,480],el:[],gw:[1349],gh:[508],type:'standard',justify:'',layout:'fullwidth',mh:\"0\"});if (window.RS_MODULES!==undefined && window.RS_MODULES.modules!==undefined && window.RS_MODULES.modules[\"revslider91\"]!==undefined) {window.RS_MODULES.modules[\"revslider91\"].once = false;window.revapi9 = undefined;if (window.RS_MODULES.checkMinimal!==undefined) window.RS_MODULES.checkMinimal()}\n\t\t\t\t<\/script>\n\t\t\t<\/rs-module-wrap>\n\t\t\t<!-- END REVOLUTION SLIDER -->\n<\/div>\n\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t            <\/div>\r\n        <\/div>\r\n        \t\t\t<\/div>\r\n\t\t<\/div>\r\n\t\t\t\t<div class=\"elementor-section elementor-top-section elementor-element elementor-element-fe34e6e elementor-section-boxed elementor-section-height-default elementor-section-height-default cms-remove-row-no cms-section-no-padding-no cms-boxed-bg-false cms-section-boxed-divider-false cms-overlay-gradient-bg-yes cms-overlay-gradient-mode-tb\" data-id=\"fe34e6e\" data-element_type=\"section\" data-e-type=\"section\">\r\n\t\t\t<div class=\"cms-overlay-gradient\"><\/div><div class=\"cms-section-boxed-bg\"><\/div><div class=\"cms-section-boxed-divider\"><\/div><div class=\"cms-elementor-section-remove\"><\/div><div class=\"cms-elementor-section-corner cms-elementor-section-corner-top\"><\/div><div class=\"cms-elementor-section-corner cms-elementor-section-corner-bottom\"><\/div>\t\t\t<div class=\"elementor-container elementor-column-gap-default \" >\r\n\t\t\t        <div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5803eb2\" data-id=\"5803eb2\" data-element_type=\"column\" data-e-type=\"column\">\r\n            <div class=\"elementor-widget-wrap elementor-element-populated\">\r\n                \t\t<div class=\"elementor-element elementor-element-dc180f3 elementor-widget elementor-widget-heading\" data-id=\"dc180f3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">CASE STUDIES<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t            <\/div>\r\n        <\/div>\r\n        \t\t\t<\/div>\r\n\t\t<\/div>\r\n\t\t\t\t<div class=\"elementor-section elementor-top-section elementor-element elementor-element-4a0c75d elementor-section-boxed elementor-section-height-default elementor-section-height-default cms-remove-row-no cms-section-no-padding-no cms-boxed-bg-false cms-section-boxed-divider-false cms-overlay-gradient-bg-yes cms-overlay-gradient-mode-tb\" data-id=\"4a0c75d\" data-element_type=\"section\" data-e-type=\"section\">\r\n\t\t\t<div class=\"cms-overlay-gradient\"><\/div><div class=\"cms-section-boxed-bg\"><\/div><div class=\"cms-section-boxed-divider\"><\/div><div class=\"cms-elementor-section-remove\"><\/div><div class=\"cms-elementor-section-corner cms-elementor-section-corner-top\"><\/div><div class=\"cms-elementor-section-corner cms-elementor-section-corner-bottom\"><\/div>\t\t\t<div class=\"elementor-container elementor-column-gap-default \" >\r\n\t\t\t        <div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-71f52b8\" data-id=\"71f52b8\" data-element_type=\"column\" data-e-type=\"column\">\r\n            <div class=\"elementor-widget-wrap elementor-element-populated\">\r\n                \t\t<div class=\"elementor-element elementor-element-e09664c elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"e09664c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t            <\/div>\r\n        <\/div>\r\n        \t\t\t<\/div>\r\n\t\t<\/div>\r\n\t\t\t\t<div class=\"elementor-section elementor-top-section elementor-element elementor-element-6ddb6af elementor-section-boxed elementor-section-height-default elementor-section-height-default cms-remove-row-no cms-section-no-padding-no cms-boxed-bg-false cms-section-boxed-divider-false cms-overlay-gradient-bg-yes cms-overlay-gradient-mode-tb\" data-id=\"6ddb6af\" data-element_type=\"section\" data-e-type=\"section\">\r\n\t\t\t<div class=\"cms-overlay-gradient\"><\/div><div class=\"cms-section-boxed-bg\"><\/div><div class=\"cms-section-boxed-divider\"><\/div><div class=\"cms-elementor-section-remove\"><\/div><div class=\"cms-elementor-section-corner cms-elementor-section-corner-top\"><\/div><div class=\"cms-elementor-section-corner cms-elementor-section-corner-bottom\"><\/div>\t\t\t<div class=\"elementor-container elementor-column-gap-default \" >\r\n\t\t\t        <div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-961e0e1\" data-id=\"961e0e1\" data-element_type=\"column\" data-e-type=\"column\">\r\n            <div class=\"elementor-widget-wrap elementor-element-populated\">\r\n                \t\t<div class=\"elementor-element elementor-element-313a82a elementor-widget elementor-widget-text-editor\" data-id=\"313a82a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Let Vantage BioTrials\u2019 vast industry experience guide you in making an informed decision about how to conduct your clinical trials. \u00a0All of our case-studies are real life situations which\u00a0can serve as valuable examples in creating\u00a0training tools for your needs.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t            <\/div>\r\n        <\/div>\r\n                <div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-a6b7cef\" data-id=\"a6b7cef\" data-element_type=\"column\" data-e-type=\"column\">\r\n            <div class=\"elementor-widget-wrap\">\r\n                            <\/div>\r\n        <\/div>\r\n        \t\t\t<\/div>\r\n\t\t<\/div>\r\n\t\t\t\t<div class=\"elementor-section elementor-top-section elementor-element elementor-element-d89efe8 elementor-section-boxed elementor-section-height-default elementor-section-height-default cms-remove-row-no cms-section-no-padding-no cms-boxed-bg-false cms-section-boxed-divider-false cms-overlay-gradient-bg-yes cms-overlay-gradient-mode-tb\" data-id=\"d89efe8\" data-element_type=\"section\" data-e-type=\"section\">\r\n\t\t\t<div class=\"cms-overlay-gradient\"><\/div><div class=\"cms-section-boxed-bg\"><\/div><div class=\"cms-section-boxed-divider\"><\/div><div class=\"cms-elementor-section-remove\"><\/div><div class=\"cms-elementor-section-corner cms-elementor-section-corner-top\"><\/div><div class=\"cms-elementor-section-corner cms-elementor-section-corner-bottom\"><\/div>\t\t\t<div class=\"elementor-container elementor-column-gap-default \" >\r\n\t\t\t        <div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-76c8093\" data-id=\"76c8093\" data-element_type=\"column\" data-e-type=\"column\">\r\n            <div class=\"elementor-widget-wrap elementor-element-populated\">\r\n                \t\t<div class=\"elementor-element elementor-element-a7f3a07 elementor-widget elementor-widget-html\" data-id=\"a7f3a07\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style>.elementor-accordion .elementor-accordion-item:first-of-type {\ndisplay: none;}\n.elementor-accordion {\n  border-top: 1px solid  #D4DFF2C7;\n}<\/style>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-46e9de9 elementor-widget elementor-widget-accordion\" data-id=\"46e9de9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-7431\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-7431\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Case Study 1: Competing Studies For a Phase III Infectious Disease Trial<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-7431\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-7431\"><p>VBT was aware of a number of ongoing studies in skin and skin structure infections, thus patient enrollment would potentially be affected by competing trials. Therefore, it was imperative that both our Sponsor and our internal team generate enthusiasm for this particular protocol. We began by enabling a comprehensive and targeted feasibility study to identify and evaluate upcoming competing studies, followed by an educative session with the Investigators on the biologic attributes of the study drug specifically with regard to its rapid bacteriacidal activity, potentially faster rates of resolution, and its potential to limit the development of resistance due to its multiple mechanisms of action. And finally, we recommended that the Sponsor offer more competitive Investigator grants. All these proactive steps resulted in targeted high enrollment rates for the majority of participating research sites.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-7432\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-7432\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Case Study 1: Competing Studies For a Phase III Infectious Disease Trial<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-7432\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-7432\"><p>VBT was aware of a number of ongoing studies in skin and skin structure infections, thus patient enrollment would potentially be affected by competing trials. Therefore, it was imperative that both our Sponsor and our internal team generate enthusiasm for this particular protocol. We began by enabling a comprehensive and targeted feasibility study to identify and evaluate upcoming competing studies, followed by an educative session with the Investigators on the biologic attributes of the study drug specifically with regard to its rapid bacteriacidal activity, potentially faster rates of resolution, and its potential to limit the development of resistance due to its multiple mechanisms of action. And finally, we recommended that the Sponsor offer more competitive Investigator grants. All these proactive steps resulted in targeted high enrollment rates for the majority of participating research sites.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-7433\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-7433\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Case Study 2: Maintaining the Study Blind for a Phase III gastro-intenstinal trial<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-7433\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-7433\"><p>During the development of the protocol, VBT\u2019s scientific team foresaw that maintaining the blind would pose a potential risk for the study, as we assumed the study drug and the comparator were not blinded. Also, the requirements for the study drug level monitoring varied, and many institutions required that the study drug levels be reviewed by either a pharmacist or a physician. Sites needed to ensure that systems were in place so that study drug levels are not inadvertently revealed to blinded study staff. Therefore, our team proposed the use of unblinded monitors who would be responsible for the following:<\/p><ul><li>Ensure correct dose of study drug was dispensed<\/li><li>Ensure proper storage of study drug<\/li><li>Ensure proper return of used and unused vials<\/li><li>Verify and retrieve study drug accountability pages<\/li><li>Ensure that study drug levels are appropriately monitored, if applicable, and blinded from blinded study staff<\/li><\/ul><p>We previously had experience with a very similar study and worked closely with sites to develop site specific plans that outlined how the blind would be maintained at each site prior to the site enrolling subjects.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-7434\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-7434\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Case Study 3: Preserving Patient Eligibility in a Complex Phase II Variceal Bleeding Trial<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-7434\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-7434\"><h2 style=\"line-height: normal;\"><b><span style=\"font-size: 17.0pt; font-family: 'Lato Light',sans-serif; color: #0070c0; mso-font-kerning: 0pt; mso-ligatures: none;\">Challenge<\/span><\/b><\/h2>\n<p><span style=\"font-family: 'Lato',sans-serif;\">A biotech sponsor conducting a Phase II study in patients with acute variceal bleeding faced a significant enrollment and evaluability risk.<\/span><\/p>\n<p><span style=\"font-family: 'Lato',sans-serif;\">Due to the urgent nature of the condition, potentially eligible patients frequently presented through emergency departments or other hospital units requiring immediate medical intervention. Once certain non-study therapies were administered as part of standard clinical care, patients became ineligible for study participation.<\/span><\/p>\n<p><span style=\"font-family: 'Lato',sans-serif;\">Without effective identification and referral processes, eligible subjects could be lost before study teams were notified, negatively impacting enrollment rates, patient evaluability, and overall study timelines.<\/span><\/p>\n<h2 style=\"line-height: normal;\"><span style=\"font-size: 18.0pt; font-family: 'Lato',sans-serif; color: #0070c0; mso-font-kerning: 0pt; mso-ligatures: none;\">Vantage BioTrials Approach<\/span><\/h2>\n<p><span style=\"font-family: 'Lato',sans-serif;\">Vantage BioTrials conducted an early operational assessment of the patient care pathway and identified patient identification and referral processes as critical success factors for study execution.<\/span><\/p>\n<p><span style=\"font-family: 'Lato',sans-serif;\">To mitigate enrollment risk, Vantage BioTrials implemented a multi-faceted strategy focused on site selection, staff education, and internal communication workflows.<\/span><\/p>\n<p><span style=\"font-family: 'Lato',sans-serif;\">First, participating sites were carefully selected based on their demonstrated ability to coordinate patient care across multiple hospital departments and maintain effective internal referral networks. Particular emphasis was placed on institutions with established communication pathways between emergency medicine, gastroenterology, hepatology, critical care, and research personnel.<\/span><\/p>\n<p><span style=\"font-family: 'Lato',sans-serif;\">Recognizing that eligible patients could present through several clinical departments, Vantage BioTrials recommended comprehensive study-specific training for investigators, coordinators, emergency department personnel, and other frontline healthcare providers responsible for the initial assessment and treatment of patients with variceal bleeding.<\/span><\/p>\n<p><span style=\"font-family: 'Lato',sans-serif;\">To further strengthen site readiness, Vantage BioTrials collaborated with sites to develop customized referral plans outlining:<\/span><span style=\"font-family: Lato, sans-serif;\">&nbsp;<\/span><\/p>\n<ul style=\"margin-top: 0in;\" type=\"square\">\n<li style=\"margin-bottom: 0in; mso-list: l0 level1 lfo1; tab-stops: list .5in;\"><span style=\"font-family: 'Lato',sans-serif;\">Department-specific patient identification procedures<\/span><\/li>\n<li style=\"margin-bottom: 0in; mso-list: l0 level1 lfo1; tab-stops: list .5in;\"><span style=\"font-family: 'Lato',sans-serif;\">Escalation pathways for potential study candidates<\/span><\/li>\n<li style=\"margin-bottom: 0in; mso-list: l0 level1 lfo1; tab-stops: list .5in;\"><span style=\"font-family: 'Lato',sans-serif;\">Roles and responsibilities of clinical and research personnel<\/span><\/li>\n<li style=\"margin-bottom: 0in; mso-list: l0 level1 lfo1; tab-stops: list .5in;\"><span style=\"font-family: 'Lato',sans-serif;\">Processes for rapid notification of study staff prior to administration of disqualifying therapies<\/span><\/li>\n<\/ul>\n<p style=\"margin-bottom: 0in;\"><span style=\"font-family: 'Lato',sans-serif;\">&nbsp;<\/span><span style=\"font-family: Lato, sans-serif;\">In addition, Vantage BioTrials introduced study-specific enrollment support tools, including abbreviated eligibility reference cards containing key inclusion and exclusion criteria along with direct contact information for study coordinators and principal investigators. These tools were distributed across relevant hospital departments to facilitate rapid patient identification and referral.<\/span><\/p>\n<p><span style=\"font-family: 'Lato',sans-serif;\">To ensure consistent implementation across the study, all participating sites completed protocol-specific eligibility and referral pathway training prior to activation, and site-specific referral plans were finalized and approved before enrollment commenced.<\/span><\/p>\n<h2 style=\"line-height: normal;\"><span style=\"font-size: 20.0pt; font-family: 'Lato Medium',sans-serif; color: #0070c0; mso-font-kerning: 0pt; mso-ligatures: none;\">Outcome<\/span><\/h2>\n<p><span style=\"font-family: 'Lato',sans-serif;\">The implementation of structured referral pathways and targeted site education strengthened communication across participating institutions and improved identification of potentially eligible patients prior to treatment decisions.<\/span><\/p>\n<p><span style=\"font-family: 'Lato',sans-serif;\">One hundred percent (100%) of participating sites completed eligibility and referral pathway training prior to site activation, ensuring that clinical and research personnel were prepared to identify and refer potential study candidates appropriately.<\/span><\/p>\n<p><span style=\"font-family: 'Lato',sans-serif;\">In addition, 100% of participating sites implemented site-specific referral plans before enrolling their first patient, creating standardized processes for patient identification and rapid study team notification across participating institutions.<\/span><\/p>\n<p><span style=\"font-family: 'Lato',sans-serif;\">Most importantly, zero major protocol deviations related to patient eligibility or administration of disqualifying therapies were reported during study conduct, demonstrating the effectiveness of the proactive enrollment and referral strategy.<\/span><\/p>\n<p><span style=\"font-family: 'Lato',sans-serif;\">Collectively, these measures reduced the risk of missed enrollment opportunities, protected patient evaluability, and supported consistent recruitment performance throughout the study.<\/span><\/p>\n<h2 style=\"line-height: normal;\"><b><span style=\"font-size: 22.0pt; font-family: 'Lato Medium',sans-serif; color: #0070c0; mso-font-kerning: 0pt; mso-ligatures: none;\">Key Takeaway<\/span><\/b><\/h2>\n<p><span style=\"font-family: 'Lato',sans-serif;\">For acute care studies, successful enrollment depends not only on identifying appropriate research sites, but also on understanding how patients move through complex healthcare systems before reaching the research team.<\/span><\/p>\n<p><span style=\"font-size: 12.0pt; line-height: 115%; font-family: 'Lato',sans-serif; mso-fareast-font-family: Aptos; mso-fareast-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;\">Vantage BioTrials applies a Quality by Design approach to evaluate patient pathways, identify operational risks, and implement site-specific mitigation strategies that protect patient eligibility, improve recruitment efficiency, and support the successful execution of complex clinical trials.<\/span><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-7435\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-7435\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Case Study 4: Providing GCP & Bioequivalence Monitoring Training to Big Pharma<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-7435\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-7435\"><p>With the extensive knowledge and experiences gained from the multitude of Phase I \/ Bioequivalence studies VBT has monitored for clients over the years, we began offering Training Courses for our clients\u2019 scientific and operational teams, focusing on GCPs and practical ways to monitor these type of studies while maintaining the highest levels of quality. The response we received after each of these training sessions was tremendously positive, with feedback such as \u201cVery insightful and detailed review. I learned a lot of new aspects about the source document review process,\u201d and \u201cExcellent job with the training provided. I have never seen my team so engaged in any training session before. We definitely learned a lot!\u201d<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t            <\/div>\r\n        <\/div>\r\n        \t\t\t<\/div>\r\n\t\t<\/div>\r\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>CASE STUDIES Let Vantage BioTrials\u2019 vast industry experience guide you in making an informed decision about how to conduct your clinical trials. \u00a0All of our case-studies are real life situations which\u00a0can serve as valuable examples in creating\u00a0training tools for your needs. Case Study 1: Competing Studies For a Phase III Infectious Disease Trial VBT was aware of a number of ongoing studies in skin and skin structure infections, thus patient enrollment would potentially be affected by competing trials. Therefore, it was imperative that both our Sponsor and our internal team generate enthusiasm for this particular protocol. We began by enabling a comprehensive and targeted feasibility study to identify and evaluate upcoming competing studies, followed by an educative session with the Investigators on the biologic attributes of the study drug specifically with regard to its rapid bacteriacidal activity, potentially faster rates of resolution, and its potential to limit the development of resistance due to its multiple mechanisms of action. And finally, we recommended that the Sponsor offer more competitive Investigator grants. All these proactive steps resulted in targeted high enrollment rates for the majority of participating research sites. Case Study 1: Competing Studies For a Phase III Infectious Disease Trial VBT was aware of a number of ongoing studies in skin and skin structure infections, thus patient enrollment would potentially be affected by competing trials. Therefore, it was imperative that both our Sponsor and our internal team generate enthusiasm for this particular protocol. We began by enabling a comprehensive and targeted feasibility study to identify and evaluate upcoming competing studies, followed by an educative session with the Investigators on the biologic attributes of the study drug specifically with regard to its rapid bacteriacidal activity, potentially faster rates of resolution, and its potential to limit the development of resistance due to its multiple mechanisms of action. And finally, we recommended that the Sponsor offer more competitive Investigator grants. All these proactive steps resulted in targeted high enrollment rates for the majority of participating research sites. Case Study 2: Maintaining the Study Blind for a Phase III gastro-intenstinal trial During the development of the protocol, VBT\u2019s scientific team foresaw that maintaining the blind would pose a potential risk for the study, as we assumed the study drug and the comparator were not blinded. Also, the requirements for the study drug level monitoring varied, and many institutions required that the study drug levels be reviewed by either a pharmacist or a physician. Sites needed to ensure that systems were in place so that study drug levels are not inadvertently revealed to blinded study staff. Therefore, our team proposed the use of unblinded monitors who would be responsible for the following: Ensure correct dose of study drug was dispensed Ensure proper storage of study drug Ensure proper return of used and unused vials Verify and retrieve study drug accountability pages Ensure that study drug levels are appropriately monitored, if applicable, and blinded from blinded study staff We previously had experience with a very similar study and worked closely with sites to develop site specific plans that outlined how the blind would be maintained at each site prior to the site enrolling subjects. Case Study 3: Preserving Patient Eligibility in a Complex Phase II Variceal Bleeding Trial Challenge A biotech sponsor conducting a Phase II study in patients with acute variceal bleeding faced a significant enrollment and evaluability risk. Due to the urgent nature of the condition, potentially eligible patients frequently presented through emergency departments or other hospital units requiring immediate medical intervention. Once certain non-study therapies were administered as part of standard clinical care, patients became ineligible for study participation. Without effective identification and referral processes, eligible subjects could be lost before study teams were notified, negatively impacting enrollment rates, patient evaluability, and overall study timelines. Vantage BioTrials Approach Vantage BioTrials conducted an early operational assessment of the patient care pathway and identified patient identification and referral processes as critical success factors for study execution. To mitigate enrollment risk, Vantage BioTrials implemented a multi-faceted strategy focused on site selection, staff education, and internal communication workflows. First, participating sites were carefully selected based on their demonstrated ability to coordinate patient care across multiple hospital departments and maintain effective internal referral networks. Particular emphasis was placed on institutions with established communication pathways between emergency medicine, gastroenterology, hepatology, critical care, and research personnel. Recognizing that eligible patients could present through several clinical departments, Vantage BioTrials recommended comprehensive study-specific training for investigators, coordinators, emergency department personnel, and other frontline healthcare providers responsible for the initial assessment and treatment of patients with variceal bleeding. To further strengthen site readiness, Vantage BioTrials collaborated with sites to develop customized referral plans outlining:&nbsp; Department-specific patient identification procedures Escalation pathways for potential study candidates Roles and responsibilities of clinical and research personnel Processes for rapid notification of study staff prior to administration of disqualifying therapies &nbsp;In addition, Vantage BioTrials introduced study-specific enrollment support tools, including abbreviated eligibility reference cards containing key inclusion and exclusion criteria along with direct contact information for study coordinators and principal investigators. These tools were distributed across relevant hospital departments to facilitate rapid patient identification and referral. To ensure consistent implementation across the study, all participating sites completed protocol-specific eligibility and referral pathway training prior to activation, and site-specific referral plans were finalized and approved before enrollment commenced. Outcome The implementation of structured referral pathways and targeted site education strengthened communication across participating institutions and improved identification of potentially eligible patients prior to treatment decisions. One hundred percent (100%) of participating sites completed eligibility and referral pathway training prior to site activation, ensuring that clinical and research personnel were prepared to identify and refer potential study candidates appropriately. In addition, 100% of participating sites implemented site-specific referral plans before enrolling their first patient, creating standardized processes for patient identification and rapid study team notification across participating institutions. Most importantly, zero major protocol deviations related to patient eligibility or administration of disqualifying therapies were reported during study conduct, demonstrating the effectiveness of the proactive enrollment and referral strategy. Collectively, these measures reduced the risk of missed enrollment opportunities, protected patient evaluability, and supported consistent recruitment performance throughout the study. Key Takeaway For acute care studies, successful enrollment depends not only on identifying appropriate research sites, but also on understanding how patients move through complex healthcare systems before reaching the research team. Vantage BioTrials applies a Quality by Design approach to evaluate patient pathways, identify operational risks, and implement site-specific mitigation strategies that protect patient eligibility, improve recruitment efficiency, and support the successful execution of complex clinical trials. Case Study 4: Providing GCP &#038; Bioequivalence Monitoring Training to Big Pharma With the extensive knowledge and experiences gained from the multitude of Phase I \/ Bioequivalence studies VBT has monitored for clients over the years, we began offering Training Courses for our clients\u2019 scientific and operational teams, focusing on GCPs and practical ways to monitor these type of studies while maintaining the highest levels of quality. The response we received after each of these training sessions was tremendously positive, with feedback such as \u201cVery insightful and detailed review. I learned a lot of new aspects about the source document review process,\u201d and \u201cExcellent job with the training provided. I have never seen my team so engaged in any training session before. We definitely learned a lot!\u201d<\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-52","page","type-page","status-publish","hentry","cms-no-post-thumbnail"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/vantagebiotrials.com\/fr\/wp-json\/wp\/v2\/pages\/52","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/vantagebiotrials.com\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/vantagebiotrials.com\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/vantagebiotrials.com\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/vantagebiotrials.com\/fr\/wp-json\/wp\/v2\/comments?post=52"}],"version-history":[{"count":6,"href":"https:\/\/vantagebiotrials.com\/fr\/wp-json\/wp\/v2\/pages\/52\/revisions"}],"predecessor-version":[{"id":5148,"href":"https:\/\/vantagebiotrials.com\/fr\/wp-json\/wp\/v2\/pages\/52\/revisions\/5148"}],"wp:attachment":[{"href":"https:\/\/vantagebiotrials.com\/fr\/wp-json\/wp\/v2\/media?parent=52"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}