{"id":46,"date":"2023-08-22T02:04:22","date_gmt":"2023-08-22T02:04:22","guid":{"rendered":"https:\/\/staging.vantagebiotrials.com\/?page_id=46"},"modified":"2024-03-22T00:51:22","modified_gmt":"2024-03-22T00:51:22","slug":"servicesandsolutions","status":"publish","type":"page","link":"https:\/\/vantagebiotrials.com\/fr\/servicesandsolutions\/","title":{"rendered":"Services and Solutions"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"46\" class=\"elementor elementor-46\">\n\t\t\t\t\t\t<div class=\"elementor-section elementor-top-section elementor-element elementor-element-76e9ced elementor-section-full_width 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=\"76e9ced\" 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-no \" >\r\n\t\t\t        <div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b1e25a0\" data-id=\"b1e25a0\" 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-9d68398 elementor-widget elementor-widget-image-carousel\" data-id=\"9d68398\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;slides_to_show&quot;:&quot;1&quot;,&quot;navigation&quot;:&quot;none&quot;,&quot;autoplay&quot;:&quot;no&quot;,&quot;infinite&quot;:&quot;yes&quot;,&quot;effect&quot;:&quot;slide&quot;,&quot;speed&quot;:500}\" data-widget_type=\"image-carousel.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-image-carousel-wrapper swiper\" role=\"region\" aria-roledescription=\"carousel\" aria-label=\"Carrousel d\u2019images\" dir=\"ltr\">\n\t\t\t<div class=\"elementor-image-carousel swiper-wrapper swiper-image-stretch\" aria-live=\"polite\">\n\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"1 of 1\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/vantagebiotrials.com\/wp-content\/uploads\/elementor\/thumbs\/ThinkstockPhotos-179514990-r1dkprd0m4dv9e0syu8kkn53fay30jiaxo15qns68m.jpeg\" alt=\"ThinkstockPhotos-179514990\" \/><\/figure><\/div>\t\t\t<\/div>\n\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 class=\"elementor-section elementor-top-section elementor-element elementor-element-c700529 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=\"c700529\" 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-f654bea\" data-id=\"f654bea\" 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-537d87b elementor-widget elementor-widget-heading\" data-id=\"537d87b\" 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\">SERVICES AND SOLUTIONS<\/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-d53ca1c 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=\"d53ca1c\" 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-30ff036\" data-id=\"30ff036\" 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-a536ebd elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"a536ebd\" 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-b83856f 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=\"b83856f\" 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-79c202c\" data-id=\"79c202c\" 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-e19d9b7 elementor-widget elementor-widget-text-editor\" data-id=\"e19d9b7\" 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>Vantage BioTrials offers a wide range of clinical trial management services to its clients in the pharmaceutical and medical device industry by implementing Quality by Design (QbD) strategies, Risk-Based Approaches to Monitoring and process improvement methods to the entire clinical trial lifespan.<\/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-24fb7c7\" data-id=\"24fb7c7\" 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-db322bc elementor-widget elementor-widget-text-editor\" data-id=\"db322bc\" 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>Through our\u00a0unique model, we continue to perform international trials by offering expert services which result in flexibility of choosing full service or a-la-carte.<\/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        \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-bb856eb 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=\"bb856eb\" 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-1b73a0f\" data-id=\"1b73a0f\" 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-3edf8cd elementor-widget elementor-widget-html\" data-id=\"3edf8cd\" 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-d8d89cf elementor-widget elementor-widget-accordion\" data-id=\"d8d89cf\" 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-2271\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-2271\" 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\">Phase I<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2271\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-2271\"><p>When planning your next Bioequivalence or Phase I trial, look no further than Vantage BioTrials to deliver the following range of services to accomplish your goals:<\/p><ul><li>Study Design<\/li><li>Feasibility Assessments<\/li><li>Protocol Development<\/li><li>Site Selection<\/li><li>Project Management<\/li><li>Clinical Monitoring (Bilingual)<\/li><li>Case Report Form Design<\/li><li>Document Management<\/li><li>Medical Writing<\/li><li>Quality Assurance (GCP\/GLP Audits)<\/li><\/ul><p>With hundreds of Bioequivalence\/Phase I trials monitored to date for our Generic Pharmaceutical, Consumer Health, Biotechnology and Biopharma Sponsors, we are the only expert service provider in Canada with so much experience in handling these type of early-phase trials.\u00a0 With our\u00a0<em>Risk Based Approach<\/em>\u00a0to monitoring, we will ensure:<\/p><ul><li>Interpreting the metrics, performance indicators, and trends that emerge from centralized monitoring to ensure proactive decision making and interventions<\/li><li>Ensuring continuous flow of study data that is being monitored for trends to enable real-time decision making and action<\/li><li>Qualitative reports<\/li><\/ul><p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-1087\" src=\"https:\/\/vantagebiotrials.com\/wp-content\/uploads\/2023\/11\/4-1.jpeg\" alt=\"\" width=\"559\" height=\"278\" srcset=\"https:\/\/vantagebiotrials.com\/wp-content\/uploads\/2023\/11\/4-1.jpeg 559w, https:\/\/vantagebiotrials.com\/wp-content\/uploads\/2023\/11\/4-1-18x9.jpeg 18w\" sizes=\"(max-width: 559px) 100vw, 559px\" \/><\/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-2272\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-2272\" 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\">Phase I<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2272\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-2272\"><p>When planning your next Bioequivalence or Phase I trial, look no further than Vantage BioTrials to deliver the following range of services to accomplish your goals:<\/p><ul><li>Study Design<\/li><li>Feasibility Assessments<\/li><li>Protocol Development<\/li><li>Site Selection<\/li><li>Project Management<\/li><li>Clinical Monitoring (Bilingual)<\/li><li>Case Report Form Design<\/li><li>Document Management<\/li><li>Medical Writing<\/li><li>Quality Assurance (GCP\/GLP Audits)<\/li><\/ul><p>With hundreds of Bioequivalence\/Phase I trials monitored to date for our Generic Pharmaceutical, Consumer Health, Biotechnology and Biopharma Sponsors, we are the only expert service provider in Canada with so much experience in handling these type of early-phase trials.\u00a0 With our\u00a0<em>Risk Based Approach<\/em>\u00a0to monitoring, we will ensure:<\/p><ul><li>Interpreting the metrics, performance indicators, and trends that emerge from centralized monitoring to ensure proactive decision making and interventions<\/li><li>Ensuring continuous flow of study data that is being monitored for trends to enable real-time decision making and action<\/li><li>Qualitative reports<\/li><\/ul><p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-1087\" src=\"https:\/\/vantagebiotrials.com\/wp-content\/uploads\/2023\/11\/4-1.jpeg\" alt=\"\" width=\"559\" height=\"278\" srcset=\"https:\/\/vantagebiotrials.com\/wp-content\/uploads\/2023\/11\/4-1.jpeg 559w, https:\/\/vantagebiotrials.com\/wp-content\/uploads\/2023\/11\/4-1-18x9.jpeg 18w\" sizes=\"(max-width: 559px) 100vw, 559px\" \/><\/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-2273\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-2273\" 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\">Phase II-III<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2273\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-2273\"><p>With hundreds of highly-skilled clinical research consultants working for us throughout North America, in addition to more than 50 in Latin America, we bring the best talent and resources to the table for your late-phase studies.\u00a0 Our monitors and project managers come with more than 10 years experience in Phase II-III studies.\u00a0 Rest assured that we strive in assigning the best for your trial management needs.\u00a0 As an added value, all of our associates are specially trained to trouble-shoot, manage and deliver quality results in a very pro-active way.\u00a0 The following is a list of services we offer for Phase II-III studies:<\/p><ul><li>Study Design<\/li><li>Feasibility Assessments<\/li><li>Protocol Development<\/li><li>Site Selection<\/li><li>Project Management<\/li><li>Clinical Monitoring (Bilingual)<\/li><li>Pharmacovigilance<\/li><li>Regulatory<\/li><li>Vendor Management<\/li><li>Data Management &amp; EDC Services<\/li><li>Biostatistical Analysis<\/li><li>Investigator Meeting Planning<\/li><li>Patient Recruitment Services<\/li><li>Case Report Form Design<\/li><li>Clinical Trial Agreements (CTAs)<\/li><li>Document Management<\/li><li>Medical Writing<\/li><li>Quality Assurance Audits<\/li><\/ul><\/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-2274\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-2274\" 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\">Phase IV<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2274\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-2274\"><p>With the increase of global Regulatory Agencies\u2019 demand for Late Phase programs (IIIB, IV, patient registries and observational studies), these studies have become an integral role in biopharmaceutical and medical device manufacturers\u2019 clinical, risk management, and commercialization efforts for products.<\/p><p>Vantage BioTrials has specific experience and expertise in the Late Phase arena to address regulatory &amp; risk management considerations, create meaningful data reports, and provide disease\/ product information from Late Stage &amp; Post Marketing studies.<\/p><p>At Vantage BioTrials, our experience encompasses all Late Phase studies which include:<\/p><ul><li>Post-Marketing Safety studies<\/li><li>Patient Registries<\/li><li>Observational (non-intervention) studies<\/li><li>Quality of Life (health and economical related studies)<\/li><li>Additional indication or label expansion trials<\/li><\/ul><p>Due to the breadth of size, scope and timelines of most late phase trials, Vantage BioTrials ensures that the studies\u2019 logistics, recruitment &amp; site operational requirements are well assessed and maintained. Late Phase studies\u2019 challenges including the handling of cost and extensiveness of data based on patients\u2019 and sites\u2019 volumes are proactively planned and executed.<\/p><p>Our business model provides high quality service and strategies through:<\/p><ul><li>An experienced and dedicated Project Management\u00a0 and Clinical Team<\/li><li>Focused Site Management<\/li><li>Web based technology to meet the needs of Late Stage Studies and electronic Patient Reported Outcomes<\/li><\/ul><\/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-2275\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-2275\" 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\">Medical Devices and Diagnostics<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2275\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-2275\"><p>Developing the right approach by using protocol design input and working towards a specific regulatory claim and commercial application early in the life cycle is the fastest way to market for medical devices or in vitro diagnostics.<\/p><p>Vantage BioTrials has a deep understanding of the challenges faced in clinical development for medical devices: intense competition, precise regulatory requirements and shortened product exclusivity and life cycle. Medical devices are not like drugs or vaccines.\u00a0 They even differ greatly from each other.\u00a0 That\u2019s why you need a Medical Device &amp; Diagnostics group with the broad experience of our project teams.\u00a0 We have the capability to meet your clinical development needs for both pilot and pivotal studies using efficient study management strategies that can reduce costs and shorten time lines by:<\/p><ul><li>Developing a well-designed protocol and case report forms (CRFs) to ensure high quality data and efficient monitoring<\/li><li>Site identification and feasibility analysis<\/li><li>Support Services to meet ISO 14971-2012 \u201cApplication of risk management to medical devices\u201d requirement; management procedures and practices to analyze, evaluate, control, and monitor risk relating to the safety of a medical device throughout the protocol design, development and product lifecycle<\/li><li>Application to Health Authorities, IRB\/EC submission, labeling assistance, and other global requirements. Efficiently managing study start up, and execution in accordance with ICH GCP &amp; ISO 14155-2011<\/li><li>Risk analysis\/mitigation and risk-based monitoring approach<\/li><\/ul><p>As one of the only Canadian CRO\u2019s that has established a niche for the management of Medical Device trials, Vantage BioTrials has successfully obtained numerous agency approvals, PMAs and FDA 510(k) clearances.<\/p><p><strong>Our experience includes:<\/strong><\/p><ul><li>Proof of Concept Studies<\/li><li>Companion Diagnostics<\/li><li>Implantables<\/li><li>Combined Device\/Drug Systems<\/li><li>Orthopedics<\/li><\/ul><\/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-2276\" class=\"elementor-tab-title\" data-tab=\"6\" role=\"button\" aria-controls=\"elementor-tab-content-2276\" 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\">Quality Management Independent Audits<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2276\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"6\" role=\"region\" aria-labelledby=\"elementor-tab-title-2276\"><p><em>\u201cQuality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution.\u201d \u2013 William A. Foster<\/em><\/p><p>Quality is one of Vantage BioTrials\u2019 most important elements when conducting monitoring or quality assurance audits of investigational sites or Contract Research Organizations.<\/p><p>Here\u2019s a list of what we can do for you to help maintain Quality for your studies:<\/p><ul><li>Generate audit reports and review for accuracy, clarity and completeness.<\/li><li>Ensure that impact\/validity assessments are clearly written and, where appropriate, support the facts.<\/li><li>Manage event investigation process and ensure regulatory compliance for all studies reviewed.<\/li><li>Conduct general inspections\/monitoring of Phase I-IV studies in compliance to Protocols, SOPs, GLPs, GCPs and generally accepted scientific principles.<\/li><li>Audit raw data records for completeness and within compliance to Protocols, SOPs, GLPs, GCPs, 21 CFR Part 11 and generally accepted scientific principles.<\/li><li>Audit of reports to ensure that the results incorporated accurately reflect the raw data.<\/li><li>Gap analysis of processes and organization<\/li><li>Vendor audits<\/li><li>Quality System Optimization including development of quality manuals and policies, SOPs, work instructions, QA processes, training, and regulatory inspection readiness programs.<\/li><\/ul><\/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-2277\" class=\"elementor-tab-title\" data-tab=\"7\" role=\"button\" aria-controls=\"elementor-tab-content-2277\" 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\">Study Rescue<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2277\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"7\" role=\"region\" aria-labelledby=\"elementor-tab-title-2277\"><p><strong>Site\/Study Rescue<\/strong>:<\/p><p><span style=\"font-weight: 400;\">Unfortunately it is a fact of life in clinical research to encounter issues that negatively affect or hinder the progress of your studies, especially with problematic investigative sites or poor quality of work provided by other CROs.\u00a0 With our experience handling complicated trials, our Sponsors come to us to implement our Strategic Working Action Teams (SWAT) into a cohesive unit to address the issues and efficiently rescue your study from disastrous consequences.\u00a0 Our SWAT team is comprised of a small number of carefully chosen experts (including at least one senior project manager and clinical monitor) who come up with action plans to get your study back on the right track\u2026<\/span><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t<script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Phase I\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>When planning your next Bioequivalence or Phase I trial, look no further than Vantage BioTrials to deliver the following range of services to accomplish your goals:<\\\/p><ul><li>Study Design<\\\/li><li>Feasibility Assessments<\\\/li><li>Protocol Development<\\\/li><li>Site Selection<\\\/li><li>Project Management<\\\/li><li>Clinical Monitoring (Bilingual)<\\\/li><li>Case Report Form Design<\\\/li><li>Document Management<\\\/li><li>Medical Writing<\\\/li><li>Quality Assurance (GCP\\\/GLP Audits)<\\\/li><\\\/ul><p>With hundreds of Bioequivalence\\\/Phase I trials monitored to date for our Generic Pharmaceutical, Consumer Health, Biotechnology and Biopharma Sponsors, we are the only expert service provider in Canada with so much experience in handling these type of early-phase trials.\\u00a0 With our\\u00a0<em>Risk Based Approach<\\\/em>\\u00a0to monitoring, we will ensure:<\\\/p><ul><li>Interpreting the metrics, performance indicators, and trends that emerge from centralized monitoring to ensure proactive decision making and interventions<\\\/li><li>Ensuring continuous flow of study data that is being monitored for trends to enable real-time decision making and action<\\\/li><li>Qualitative reports<\\\/li><\\\/ul><p><img class=\\\"alignnone size-full wp-image-1087\\\" src=\\\"https:\\\/\\\/vantagebiotrials.com\\\/wp-content\\\/uploads\\\/2023\\\/11\\\/4-1.jpeg\\\" alt=\\\"\\\" width=\\\"559\\\" height=\\\"278\\\" \\\/><\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"Phase I\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>When planning your next Bioequivalence or Phase I trial, look no further than Vantage BioTrials to deliver the following range of services to accomplish your goals:<\\\/p><ul><li>Study Design<\\\/li><li>Feasibility Assessments<\\\/li><li>Protocol Development<\\\/li><li>Site Selection<\\\/li><li>Project Management<\\\/li><li>Clinical Monitoring (Bilingual)<\\\/li><li>Case Report Form Design<\\\/li><li>Document Management<\\\/li><li>Medical Writing<\\\/li><li>Quality Assurance (GCP\\\/GLP Audits)<\\\/li><\\\/ul><p>With hundreds of Bioequivalence\\\/Phase I trials monitored to date for our Generic Pharmaceutical, Consumer Health, Biotechnology and Biopharma Sponsors, we are the only expert service provider in Canada with so much experience in handling these type of early-phase trials.\\u00a0 With our\\u00a0<em>Risk Based Approach<\\\/em>\\u00a0to monitoring, we will ensure:<\\\/p><ul><li>Interpreting the metrics, performance indicators, and trends that emerge from centralized monitoring to ensure proactive decision making and interventions<\\\/li><li>Ensuring continuous flow of study data that is being monitored for trends to enable real-time decision making and action<\\\/li><li>Qualitative reports<\\\/li><\\\/ul><p><img class=\\\"alignnone size-full wp-image-1087\\\" src=\\\"https:\\\/\\\/vantagebiotrials.com\\\/wp-content\\\/uploads\\\/2023\\\/11\\\/4-1.jpeg\\\" alt=\\\"\\\" width=\\\"559\\\" height=\\\"278\\\" \\\/><\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"Phase II-III\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>With hundreds of highly-skilled clinical research consultants working for us throughout North America, in addition to more than 50 in Latin America, we bring the best talent and resources to the table for your late-phase studies.\\u00a0 Our monitors and project managers come with more than 10 years experience in Phase II-III studies.\\u00a0 Rest assured that we strive in assigning the best for your trial management needs.\\u00a0 As an added value, all of our associates are specially trained to trouble-shoot, manage and deliver quality results in a very pro-active way.\\u00a0 The following is a list of services we offer for Phase II-III studies:<\\\/p><ul><li>Study Design<\\\/li><li>Feasibility Assessments<\\\/li><li>Protocol Development<\\\/li><li>Site Selection<\\\/li><li>Project Management<\\\/li><li>Clinical Monitoring (Bilingual)<\\\/li><li>Pharmacovigilance<\\\/li><li>Regulatory<\\\/li><li>Vendor Management<\\\/li><li>Data Management &amp; EDC Services<\\\/li><li>Biostatistical Analysis<\\\/li><li>Investigator Meeting Planning<\\\/li><li>Patient Recruitment Services<\\\/li><li>Case Report Form Design<\\\/li><li>Clinical Trial Agreements (CTAs)<\\\/li><li>Document Management<\\\/li><li>Medical Writing<\\\/li><li>Quality Assurance Audits<\\\/li><\\\/ul>\"}},{\"@type\":\"Question\",\"name\":\"Phase IV\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>With the increase of global Regulatory Agencies\\u2019 demand for Late Phase programs (IIIB, IV, patient registries and observational studies), these studies have become an integral role in biopharmaceutical and medical device manufacturers\\u2019 clinical, risk management, and commercialization efforts for products.<\\\/p><p>Vantage BioTrials has specific experience and expertise in the Late Phase arena to address regulatory &amp; risk management considerations, create meaningful data reports, and provide disease\\\/ product information from Late Stage &amp; Post Marketing studies.<\\\/p><p>At Vantage BioTrials, our experience encompasses all Late Phase studies which include:<\\\/p><ul><li>Post-Marketing Safety studies<\\\/li><li>Patient Registries<\\\/li><li>Observational (non-intervention) studies<\\\/li><li>Quality of Life (health and economical related studies)<\\\/li><li>Additional indication or label expansion trials<\\\/li><\\\/ul><p>Due to the breadth of size, scope and timelines of most late phase trials, Vantage BioTrials ensures that the studies\\u2019 logistics, recruitment &amp; site operational requirements are well assessed and maintained. Late Phase studies\\u2019 challenges including the handling of cost and extensiveness of data based on patients\\u2019 and sites\\u2019 volumes are proactively planned and executed.<\\\/p><p>Our business model provides high quality service and strategies through:<\\\/p><ul><li>An experienced and dedicated Project Management\\u00a0 and Clinical Team<\\\/li><li>Focused Site Management<\\\/li><li>Web based technology to meet the needs of Late Stage Studies and electronic Patient Reported Outcomes<\\\/li><\\\/ul>\"}},{\"@type\":\"Question\",\"name\":\"Medical Devices and Diagnostics\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>Developing the right approach by using protocol design input and working towards a specific regulatory claim and commercial application early in the life cycle is the fastest way to market for medical devices or in vitro diagnostics.<\\\/p><p>Vantage BioTrials has a deep understanding of the challenges faced in clinical development for medical devices: intense competition, precise regulatory requirements and shortened product exclusivity and life cycle. Medical devices are not like drugs or vaccines.\\u00a0 They even differ greatly from each other.\\u00a0 That\\u2019s why you need a Medical Device &amp; Diagnostics group with the broad experience of our project teams.\\u00a0 We have the capability to meet your clinical development needs for both pilot and pivotal studies using efficient study management strategies that can reduce costs and shorten time lines by:<\\\/p><ul><li>Developing a well-designed protocol and case report forms (CRFs) to ensure high quality data and efficient monitoring<\\\/li><li>Site identification and feasibility analysis<\\\/li><li>Support Services to meet ISO 14971-2012 \\u201cApplication of risk management to medical devices\\u201d requirement; management procedures and practices to analyze, evaluate, control, and monitor risk relating to the safety of a medical device throughout the protocol design, development and product lifecycle<\\\/li><li>Application to Health Authorities, IRB\\\/EC submission, labeling assistance, and other global requirements. Efficiently managing study start up, and execution in accordance with ICH GCP &amp; ISO 14155-2011<\\\/li><li>Risk analysis\\\/mitigation and risk-based monitoring approach<\\\/li><\\\/ul><p>As one of the only Canadian CRO\\u2019s that has established a niche for the management of Medical Device trials, Vantage BioTrials has successfully obtained numerous agency approvals, PMAs and FDA 510(k) clearances.<\\\/p><p><strong>Our experience includes:<\\\/strong><\\\/p><ul><li>Proof of Concept Studies<\\\/li><li>Companion Diagnostics<\\\/li><li>Implantables<\\\/li><li>Combined Device\\\/Drug Systems<\\\/li><li>Orthopedics<\\\/li><\\\/ul>\"}},{\"@type\":\"Question\",\"name\":\"Quality Management Independent Audits\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p><em>\\u201cQuality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution.\\u201d \\u2013 William A. Foster<\\\/em><\\\/p><p>Quality is one of Vantage BioTrials\\u2019 most important elements when conducting monitoring or quality assurance audits of investigational sites or Contract Research Organizations.<\\\/p><p>Here\\u2019s a list of what we can do for you to help maintain Quality for your studies:<\\\/p><ul><li>Generate audit reports and review for accuracy, clarity and completeness.<\\\/li><li>Ensure that impact\\\/validity assessments are clearly written and, where appropriate, support the facts.<\\\/li><li>Manage event investigation process and ensure regulatory compliance for all studies reviewed.<\\\/li><li>Conduct general inspections\\\/monitoring of Phase I-IV studies in compliance to Protocols, SOPs, GLPs, GCPs and generally accepted scientific principles.<\\\/li><li>Audit raw data records for completeness and within compliance to Protocols, SOPs, GLPs, GCPs, 21 CFR Part 11 and generally accepted scientific principles.<\\\/li><li>Audit of reports to ensure that the results incorporated accurately reflect the raw data.<\\\/li><li>Gap analysis of processes and organization<\\\/li><li>Vendor audits<\\\/li><li>Quality System Optimization including development of quality manuals and policies, SOPs, work instructions, QA processes, training, and regulatory inspection readiness programs.<\\\/li><\\\/ul>\"}},{\"@type\":\"Question\",\"name\":\"Study Rescue\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p><strong>Site\\\/Study Rescue<\\\/strong>:<\\\/p><p><span style=\\\"font-weight: 400;\\\">Unfortunately it is a fact of life in clinical research to encounter issues that negatively affect or hinder the progress of your studies, especially with problematic investigative sites or poor quality of work provided by other CROs.\\u00a0 With our experience handling complicated trials, our Sponsors come to us to implement our Strategic Working Action Teams (SWAT) into a cohesive unit to address the issues and efficiently rescue your study from disastrous consequences.\\u00a0 Our SWAT team is comprised of a small number of carefully chosen experts (including at least one senior project manager and clinical monitor) who come up with action plans to get your study back on the right track\\u2026<\\\/span><\\\/p>\"}}]}<\/script>\n\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>SERVICES AND SOLUTIONS Vantage BioTrials offers a wide range of clinical trial management services to its clients in the pharmaceutical and medical device industry by implementing Quality by Design (QbD) strategies, Risk-Based Approaches to Monitoring and process improvement methods to the entire clinical trial lifespan. Through our\u00a0unique model, we continue to perform international trials by offering expert services which result in flexibility of choosing full service or a-la-carte. Phase I When planning your next Bioequivalence or Phase I trial, look no further than Vantage BioTrials to deliver the following range of services to accomplish your goals: Study Design Feasibility Assessments Protocol Development Site Selection Project Management Clinical Monitoring (Bilingual) Case Report Form Design Document Management Medical Writing Quality Assurance (GCP\/GLP Audits) With hundreds of Bioequivalence\/Phase I trials monitored to date for our Generic Pharmaceutical, Consumer Health, Biotechnology and Biopharma Sponsors, we are the only expert service provider in Canada with so much experience in handling these type of early-phase trials.\u00a0 With our\u00a0Risk Based Approach\u00a0to monitoring, we will ensure: Interpreting the metrics, performance indicators, and trends that emerge from centralized monitoring to ensure proactive decision making and interventions Ensuring continuous flow of study data that is being monitored for trends to enable real-time decision making and action Qualitative reports Phase I When planning your next Bioequivalence or Phase I trial, look no further than Vantage BioTrials to deliver the following range of services to accomplish your goals: Study Design Feasibility Assessments Protocol Development Site Selection Project Management Clinical Monitoring (Bilingual) Case Report Form Design Document Management Medical Writing Quality Assurance (GCP\/GLP Audits) With hundreds of Bioequivalence\/Phase I trials monitored to date for our Generic Pharmaceutical, Consumer Health, Biotechnology and Biopharma Sponsors, we are the only expert service provider in Canada with so much experience in handling these type of early-phase trials.\u00a0 With our\u00a0Risk Based Approach\u00a0to monitoring, we will ensure: Interpreting the metrics, performance indicators, and trends that emerge from centralized monitoring to ensure proactive decision making and interventions Ensuring continuous flow of study data that is being monitored for trends to enable real-time decision making and action Qualitative reports Phase II-III With hundreds of highly-skilled clinical research consultants working for us throughout North America, in addition to more than 50 in Latin America, we bring the best talent and resources to the table for your late-phase studies.\u00a0 Our monitors and project managers come with more than 10 years experience in Phase II-III studies.\u00a0 Rest assured that we strive in assigning the best for your trial management needs.\u00a0 As an added value, all of our associates are specially trained to trouble-shoot, manage and deliver quality results in a very pro-active way.\u00a0 The following is a list of services we offer for Phase II-III studies: Study Design Feasibility Assessments Protocol Development Site Selection Project Management Clinical Monitoring (Bilingual) Pharmacovigilance Regulatory Vendor Management Data Management &amp; EDC Services Biostatistical Analysis Investigator Meeting Planning Patient Recruitment Services Case Report Form Design Clinical Trial Agreements (CTAs) Document Management Medical Writing Quality Assurance Audits Phase IV With the increase of global Regulatory Agencies\u2019 demand for Late Phase programs (IIIB, IV, patient registries and observational studies), these studies have become an integral role in biopharmaceutical and medical device manufacturers\u2019 clinical, risk management, and commercialization efforts for products. Vantage BioTrials has specific experience and expertise in the Late Phase arena to address regulatory &amp; risk management considerations, create meaningful data reports, and provide disease\/ product information from Late Stage &amp; Post Marketing studies. At Vantage BioTrials, our experience encompasses all Late Phase studies which include: Post-Marketing Safety studies Patient Registries Observational (non-intervention) studies Quality of Life (health and economical related studies) Additional indication or label expansion trials Due to the breadth of size, scope and timelines of most late phase trials, Vantage BioTrials ensures that the studies\u2019 logistics, recruitment &amp; site operational requirements are well assessed and maintained. Late Phase studies\u2019 challenges including the handling of cost and extensiveness of data based on patients\u2019 and sites\u2019 volumes are proactively planned and executed. Our business model provides high quality service and strategies through: An experienced and dedicated Project Management\u00a0 and Clinical Team Focused Site Management Web based technology to meet the needs of Late Stage Studies and electronic Patient Reported Outcomes Medical Devices and Diagnostics Developing the right approach by using protocol design input and working towards a specific regulatory claim and commercial application early in the life cycle is the fastest way to market for medical devices or in vitro diagnostics. Vantage BioTrials has a deep understanding of the challenges faced in clinical development for medical devices: intense competition, precise regulatory requirements and shortened product exclusivity and life cycle. Medical devices are not like drugs or vaccines.\u00a0 They even differ greatly from each other.\u00a0 That\u2019s why you need a Medical Device &amp; Diagnostics group with the broad experience of our project teams.\u00a0 We have the capability to meet your clinical development needs for both pilot and pivotal studies using efficient study management strategies that can reduce costs and shorten time lines by: Developing a well-designed protocol and case report forms (CRFs) to ensure high quality data and efficient monitoring Site identification and feasibility analysis Support Services to meet ISO 14971-2012 \u201cApplication of risk management to medical devices\u201d requirement; management procedures and practices to analyze, evaluate, control, and monitor risk relating to the safety of a medical device throughout the protocol design, development and product lifecycle Application to Health Authorities, IRB\/EC submission, labeling assistance, and other global requirements. Efficiently managing study start up, and execution in accordance with ICH GCP &amp; ISO 14155-2011 Risk analysis\/mitigation and risk-based monitoring approach As one of the only Canadian CRO\u2019s that has established a niche for the management of Medical Device trials, Vantage BioTrials has successfully obtained numerous agency approvals, PMAs and FDA 510(k) clearances. Our experience includes: Proof of Concept Studies Companion Diagnostics Implantables Combined Device\/Drug Systems Orthopedics Quality Management Independent Audits \u201cQuality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution.\u201d \u2013 William A. Foster Quality is one of Vantage BioTrials\u2019 most important elements when conducting monitoring or quality assurance audits of investigational sites or Contract Research Organizations. Here\u2019s a list of what we can do for you to help maintain Quality for your studies: Generate audit reports and review for accuracy, clarity and completeness. Ensure that impact\/validity assessments are clearly written and, where appropriate, support the facts. Manage event investigation process and ensure regulatory compliance for all studies reviewed. Conduct general inspections\/monitoring of Phase I-IV studies in compliance to Protocols, SOPs, GLPs, GCPs and generally accepted scientific principles. Audit raw data records for completeness and within compliance to Protocols, SOPs, GLPs, GCPs, 21 CFR Part 11 and generally accepted scientific principles. Audit of reports to ensure that the results incorporated accurately reflect the raw data. Gap analysis of processes and organization Vendor audits Quality System Optimization including development of quality manuals and policies, SOPs, work instructions, QA processes, training, and regulatory inspection readiness programs. Study Rescue Site\/Study Rescue: Unfortunately it is a fact of life in clinical research to encounter issues that negatively affect or hinder the progress of your studies, especially with problematic investigative sites or poor quality of work provided by other CROs.\u00a0 With our experience handling complicated trials, our Sponsors come to us to implement our Strategic Working Action Teams (SWAT) into a cohesive unit to address the issues and efficiently rescue your study from disastrous consequences.\u00a0 Our SWAT team is comprised of a small number of carefully chosen experts (including at least one senior project manager and clinical monitor) who come up with action plans to get your study back on the right track\u2026<\/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-46","page","type-page","status-publish","hentry","cms-no-post-thumbnail"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/vantagebiotrials.com\/fr\/wp-json\/wp\/v2\/pages\/46","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=46"}],"version-history":[{"count":0,"href":"https:\/\/vantagebiotrials.com\/fr\/wp-json\/wp\/v2\/pages\/46\/revisions"}],"wp:attachment":[{"href":"https:\/\/vantagebiotrials.com\/fr\/wp-json\/wp\/v2\/media?parent=46"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}