Clinical Trial Safety Management - Pharmacovigilance

<!doctype html><html lang="en"><head> <meta charset="utf-8"> <title>Clinical Trial Safety Management - Pharmacovigilance | Veristat</title> <link rel="shortcut icon" href="https://www.veristat.com/hubfs/favicon.ico"> <meta name="description" content="As part of the Regulatory Affairs Service offering, Veristat offers global Clinical trial safety management and european pharmacovigilance services."> <meta name="viewport" content="width=device-width, initial-scale=1"> <script src="/hs/hsstatic/jquery-libs/static-1.1/jquery/jquery-1.7.1.js"></script> <script>hsjQuery = window['jQuery'];</script> <meta property="og:description" content="As part of the Regulatory Affairs Service offering, Veristat offers global Clinical trial safety management and european pharmacovigilance services."> <meta property="og:title" content="Clinical Trial Safety Management - Pharmacovigilance | Veristat"> <meta name="twitter:description" content="As part of the Regulatory Affairs Service offering, Veristat offers global Clinical trial safety management and european pharmacovigilance services."> <meta name="twitter:title" content="Clinical Trial Safety Management - Pharmacovigilance | Veristat"> <style> a.cta_button{-moz-box-sizing:content-box !important;-webkit-box-sizing:content-box !important;box-sizing:content-box !important;vertical-align:middle}.hs-breadcrumb-menu{list-style-type:none;margin:0px 0px 0px 0px;padding:0px 0px 0px 0px}.hs-breadcrumb-menu-item{float:left;padding:10px 0px 10px 10px}.hs-breadcrumb-menu-divider:before{content:'›';padding-left:10px}.hs-featured-image-link{border:0}.hs-featured-image{float:right;margin:0 0 20px 20px;max-width:50%}@media (max-width: 568px){.hs-featured-image{float:none;margin:0;width:100%;max-width:100%}}.hs-screen-reader-text{clip:rect(1px, 1px, 1px, 1px);height:1px;overflow:hidden;position:absolute !important;width:1px} </style> <link rel="stylesheet" href="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/template_assets/63712159645/1726675697504/VERISTAT-CLEAN-2022/css/main-head.css"> <link rel="stylesheet" href="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/template_assets/63712050360/1732158771693/VERISTAT-CLEAN-2022/css/main-foot.min.css"> <link rel="stylesheet" href="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/template_assets/63711874203/1726675694524/VERISTAT-CLEAN-2022/css/modules/global-header-v2.min.css"> <style> /******************************* MAIN DESKTOP NAV STYLE *******************************/ .hhs-top-bar { background-color: rgba(249, 249, 249, 1); 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} .hhs-side-menu__ctas .hhs-side-cta-1 { display: inline-block; } } @media (max-width: 920px) { .hhs-extras-ctas .hhs-head-cta-2 { display: none; } .hhs-side-menu__ctas .hhs-side-cta-2 { display: inline-block; } } /* MAIN NAV */ @media (min-width: 768px) { .hhs-side-menu__mobile { display: none; } } @media (max-width: 768px) { .main-nav .sc-site-header__menu { display: none; } } /* FORM */ /******************************* END *******************************/ /******************************* HEADER HAT *******************************/ .hhs-header-hat { background-color: rgba(0, 102, 51, 1.0); padding: 5px 0; } .hhs-hat-menu .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-menu-depth-1 a { color: rgba(255, 255, 255, 1.0); font-size: 12px; font-weight: normal; } .hhs-hat-menu .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-menu-depth-1 a:hover { color: rgba(238, 238, 238, 1.0); } @media (max-width: 575px) { .hhs-header-hat { display: none; } } /******************************* END *******************************/ /** TABLET CSS **/ @media (max-width: 768px) { .custom-menu-primary .hs-menu-wrapper > ul { margin-top: 10px !important; 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padding-bottom: 25px; background-color: rgba(244, 244, 244, 1.0); } /** NAVIGATION COLUMNS STYLE **/ .hhs-foot-base-nav .hs-menu-wrapper.hs-menu-flow-horizontal > ul li a, .hhs-foot-nav-col .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-item-has-children ul.hs-menu-children-wrapper li a, .hhs-foot-nav-col .hs-menu-wrapper.hs-menu-flow-horizontal > ul li a { color: #888888 !important; } .hhs-foot-base-nav .hs-menu-wrapper.hs-menu-flow-horizontal > ul li a:hover, .hhs-foot-nav-col .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-item-has-children ul.hs-menu-children-wrapper li a:hover, .hhs-foot-nav-col .hs-menu-wrapper.hs-menu-flow-horizontal > ul li a:hover { color: #555555 !important; } .foot-nav-title, .hhs-foot-rss h5, .hhs-foot-nav-col h5 { margin-bottom: 28px; color: #006633; } .hhs-foot-rss .hs_cos_wrapper_type_inline_rich_text p, .hhs-foot-rss .hs_cos_wrapper_type_inline_rich_text l1, .hhs-foot-rss .hs_cos_wrapper_type_inline_rich_text span, .hhs-foot-rss label{ color: #4A4A4A; } .hhs-foot-base-nav .hs-menu-wrapper.hs-menu-flow-horizontal > ul li a { font-size: 13px; } /** BLOG POST STYLE **/ .hhs-footer-mod .hhs-post-content a h6 { color: #FFFFFF; font-size: 16px; line-height: 20px; } .hhs-footer-mod .hhs-post-summary p { color: #4A4A4A; font-size: 14px; line-height: 18px; } .hhs-foot-rss .hs-rss-title:hover { color: #00a4bd; } .hhs-footer-mod .hhs-post-feat-img { min-height: 120px; } .hhs-foot-rss .hs-rss-item.hs-with-featured-image .hs-rss-item-text { margin-top: 120px; } .hhs-foot-break-line { border-color: #006633; } .hhs-foot-copyright { color: #006633; } /** TOGGLE COLLAPSE **/ @media (max-width: 575px) { .hhs-foot-nav-col .hhs-col-content { display: none; text-align: center; } .hhs-foot-nav-col .hhs-col-content.open-menu { display: block; text-align: center; } } /** SOCIAL ICONS **/#hs_cos_wrapper_global_footer .hhs-social-con i { color: #006633;} #hs_cos_wrapper_global_footer .hhs-social-con i:hover {color: #9CCD4E;}/** TABLET CSS **/ @media (max-width: 768px) { #hs_cos_wrapper_global_footer .hhs-footer-mod { padding-top: 25px; padding-bottom: 25px; } } /** BACK TO TOP **/ #return-to-top { background: rgba(68, 68, 68, 0.7); } #return-to-top:hover { background: rgba(68, 68, 68, 0.9); } /** MOBILE CSS **/ @media (max-width: 575px) { #hs_cos_wrapper_global_footer .hhs-footer-mod { padding-top: 25px; padding-bottom: 25px; } .hhs-foot-nav-col { border-color: #006633; } } </style> <link rel="stylesheet" href="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/module_assets/63712049542/1732009637377/module_63712049542_VERIS_-_Row_-_Multi-Column_Content.min.css"> <style> /******************************* ROW STYLE *******************************/ #hs_cos_wrapper_widget_1648792364850 .hhs-text-mod { padding-top: 50px; padding-bottom: 50px;background-color: rgba(#null, 0.0);} @media (max-width: 768px) { #hs_cos_wrapper_widget_1648792364850 .hhs-text-mod { padding-top: 50px; padding-bottom: 50px; } } @media (max-width: 575px) { #hs_cos_wrapper_widget_1648792364850 .hhs-text-mod { padding-top: 25px; padding-bottom: 25px; } } /* VIDEO BACKGROUND *//* PARALLAX */ /* HERO OVERLAY COLOR *//* OUTER/INNER SHADOW *//* PULL UP ROW *//* WAVE *//******************************* END *******************************/ /******************************* COLUMN 1 *******************************/ /* TEXT STYLES */ #hs_cos_wrapper_widget_1648792364850 .c1 .hhs-rich-text, #hs_cos_wrapper_widget_1648792364850 .c1 .hhs-rich-text h1, #hs_cos_wrapper_widget_1648792364850 .c1 .hhs-rich-text h2,#hs_cos_wrapper_widget_1648792364850 .c1 .hhs-rich-text h3, #hs_cos_wrapper_widget_1648792364850 .c1 .hhs-rich-text h4, #hs_cos_wrapper_widget_1648792364850 .c1 .hhs-rich-text h5, #hs_cos_wrapper_widget_1648792364850 .c1 .hhs-rich-text h6, #hs_cos_wrapper_widget_1648792364850 .c1 .hhs-rich-text p, #hs_cos_wrapper_widget_1648792364850 .c1 .hhs-rich-text span, #hs_cos_wrapper_widget_1648792364850 .c1 .hhs-rich-text li, #hs_cos_wrapper_widget_1648792364850 .c1 .hhs-rich-text blockquote {text-align: left; }@media (max-width: 992px) { #hs_cos_wrapper_widget_1648792364850 .c1 .hhs-rich-text h1, #hs_cos_wrapper_widget_1648792364850 .c1 .hhs-rich-text h2,#hs_cos_wrapper_widget_1648792364850 .c1 .hhs-rich-text h3, #hs_cos_wrapper_widget_1648792364850 .c1 .hhs-rich-text h4, #hs_cos_wrapper_widget_1648792364850 .c1 .hhs-rich-text h5, #hs_cos_wrapper_widget_1648792364850 .c1 .hhs-rich-text h6, #hs_cos_wrapper_widget_1648792364850 .c1 .hhs-rich-text p, #hs_cos_wrapper_widget_1648792364850 .c1 .hhs-rich-text span, #hs_cos_wrapper_widget_1648792364850 .c1 .hhs-rich-text li { text-align: left; 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<div class="row"> <div data-wow-delay="none" class="wow none col-sm-12 c1 "> <div class="col-inner"> <div class="hhs-rich-text-in"> <div class="hhs-rich-text"> <p class="services">Services</p> <h2><span style="color: #4a4a4a;">Clinical Trial Patient Safety & Management</span></h2> <h1><span style="color: #00734a;">Ensuring patient safety throughout clinical trial planning and conduct is paramount</span></h1> <p>The accurate and timely capturing and reporting of serious adverse events is a critical component of a successful trial.  Ensuring proper safety reporting procedures to sites, institutional review boards (IRB) and competent regulatory authorities is of utmost importance in protecting subjects/patients as well as the integrity of the clinical study results.   Therefore, ongoing safety analyses and reporting are vital and require vigilant attention to ensure all serious adverse events are reported in accordance with <a href="/services/medical-and-regulatory-affairs/regulatory-submissions" rel="noopener" target="_blank">regulatory requirements</a>.   </p> </div> </div> </div> </div> </div> </div> <span class="hhs-row-overlay"></span> </div>      </div> </div> </div> </div> </div> </div> </div> <div class="row-fluid-wrapper row-depth-1 row-number-3 dnd-section"> <div class="row-fluid "> <div class="span12 widget-span widget-type-cell dnd-column" style="" data-widget-type="cell" data-x="0" data-w="12"> <div class="row-fluid-wrapper row-depth-1 row-number-4 dnd-row"> <div class="row-fluid "> <div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> <div id="hs_cos_wrapper_widget_1647528668130" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> <div id="" class="hhs-text-mod lazy-background show-mobile show-tablet show-desktop "><div class="container " style=""> <div class="row"> <div class="c1 col-sm-12 none "> <div class="col-inner"> <div class="hhs-rich-text-in"> <div class="hhs-rich-text"> <h4>Clinical Trial Safety Management Services</h4> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div class="row-fluid-wrapper row-depth-1 row-number-5 dnd-section"> <div class="row-fluid "> <div class="span12 widget-span widget-type-cell dnd-column" style="" data-widget-type="cell" data-x="0" data-w="12"> <div class="row-fluid-wrapper row-depth-1 row-number-6 dnd-row"> <div class="row-fluid "> <div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> <div id="hs_cos_wrapper_widget_1647528421256" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> <div id="" class="hhs-text-mod lazy-background show-mobile 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We provide:</p> <h4 style="text-align: left;"><span style="color: #006633;">Clinical Trial Safety Planning</span></h4> <ul> <li style="text-align: left;">Development of the safety management plan inclusive of outlining the safety management responsibilities between Veristat and the sponsor.</li> <li style="text-align: left;">Creation of the pregnancy/safety guidelines and forms to ensure proper reporting of pregnancy and SAEs.</li> <li style="text-align: left;">Oversight of the build and maintenance of the safety database based on the requirements of the study specific protocol (in conjunction with the <a href="https://www.veristat.com/services/biometrics/data-management" rel="noopener">Data Management</a> team).</li> </ul> </div> </div> </div> </div> <div class="c2 col-lg-6 col-sm-12 none "> <div class="col-inner"> <div class="hhs-rich-text-in"> <div class="hhs-rich-text"> <p><img src="https://www.veristat.com/hs-fs/hubfs/images_sizedat600px/people_working_manwithbeard_movember.jpg?width=600&height=400&name=people_working_manwithbeard_movember.jpg" alt="people_working_manwithbeard_movember" width="600" height="400" loading="lazy" style="height: auto; max-width: 100%; width: 600px;" srcset="https://www.veristat.com/hs-fs/hubfs/images_sizedat600px/people_working_manwithbeard_movember.jpg?width=300&height=200&name=people_working_manwithbeard_movember.jpg 300w, https://www.veristat.com/hs-fs/hubfs/images_sizedat600px/people_working_manwithbeard_movember.jpg?width=600&height=400&name=people_working_manwithbeard_movember.jpg 600w, https://www.veristat.com/hs-fs/hubfs/images_sizedat600px/people_working_manwithbeard_movember.jpg?width=900&height=600&name=people_working_manwithbeard_movember.jpg 900w, https://www.veristat.com/hs-fs/hubfs/images_sizedat600px/people_working_manwithbeard_movember.jpg?width=1200&height=800&name=people_working_manwithbeard_movember.jpg 1200w, https://www.veristat.com/hs-fs/hubfs/images_sizedat600px/people_working_manwithbeard_movember.jpg?width=1500&height=1000&name=people_working_manwithbeard_movember.jpg 1500w, https://www.veristat.com/hs-fs/hubfs/images_sizedat600px/people_working_manwithbeard_movember.jpg?width=1800&height=1200&name=people_working_manwithbeard_movember.jpg 1800w" sizes="(max-width: 600px) 100vw, 600px"></p> <p> </p> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div class="row-fluid-wrapper row-depth-1 row-number-7 dnd-section"> <div class="row-fluid "> <div class="span12 widget-span widget-type-cell dnd-column" style="" data-widget-type="cell" data-x="0" data-w="12"> <div class="row-fluid-wrapper row-depth-1 row-number-8 dnd-row"> <div class="row-fluid "> <div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> <div id="hs_cos_wrapper_module_16475287309003" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> <div id="" class="hhs-text-mod lazy-background show-mobile show-tablet show-desktop "><div class="hhs-wave-con-top"> <div class="hhs-wave-module"><svg id="opt_4" data-name="opt 4" xmlns="http://www.w3.org/2000/svg" width="1366" height="64" viewbox="0 0 1366 64" preserveaspectratio="none"><defs><style>.cls-1{fill:currentColor;fill-rule:evenodd;}</style></defs><g id="Wave-4"><path id="Rectangle-Copy-6" class="cls-1" d="M1366,64H0V.0337c205,0,709,55.6648,1366,55.6648Z"></path></g></svg></div> </div><div class="container " style=""> <div class="row"> <div class="c1 col-sm-12 none "> <div class="col-inner"> <div class="hhs-rich-text-in"> <div class="hhs-rich-text"> <h4>Safety Adverse Event (SAE) Management During Clinical Trial Conduct</h4> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div class="row-fluid-wrapper row-depth-1 row-number-9 dnd-section"> <div class="row-fluid "> <div class="span12 widget-span widget-type-cell dnd-column" style="" data-widget-type="cell" data-x="0" data-w="12"> <div class="row-fluid-wrapper row-depth-1 row-number-10 dnd-row"> <div class="row-fluid "> <div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> <div id="hs_cos_wrapper_widget_1647528815902" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> <div id="" class="hhs-text-mod lazy-background show-mobile show-tablet show-desktop "><div class="container " style=""> <div class="row"> <div class="c1 col-lg-4 col-sm-12 none "> <div class="col-inner"> <div class="hhs-rich-text-in"> <div class="hhs-rich-text"> <p><img src="https://www.veristat.com/hs-fs/hubfs/Icons_2021_sized%20216x216px/Veristat_icon_medical%20affairs-216.png?width=216&name=Veristat_icon_medical%20affairs-216.png" alt="Veristat_icon_medical affairs-216" width="216" loading="lazy" style="width: 216px; 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Discharge summaries, autopsy reports and diagnostics reports, etc)</span></li> <li><span></span><span>Drafting of safety narrative(s) according to ICH guidance encompassing relevant information and query the site for additional information</span></li> <li><span></span><span>Completion of MedWatch/CIOMS forms</span></li> <li><span></span><span>Provision of Global <a href="https://www.veristat.com/services/medical-and-regulatory-affairs/regulatory-submissions" rel="noopener" target="_blank">Submission</a> of SUSARs to regulatory agencies</span></li> </ul> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div class="row-fluid-wrapper row-depth-1 row-number-11 dnd-section"> <div class="row-fluid "> <div class="span12 widget-span widget-type-cell dnd-column" style="" data-widget-type="cell" data-x="0" data-w="12"> <div class="row-fluid-wrapper row-depth-1 row-number-12 dnd-row"> <div class="row-fluid "> <div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> <div id="hs_cos_wrapper_module_16475292731913" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> <div id="" class="hhs-text-mod lazy-background show-mobile show-tablet show-desktop "><div class="container " style=""> <div class="row"> <div class="c1 col-sm-12 none "> <div class="col-inner"> <div class="hhs-rich-text-in"> <div class="hhs-rich-text"> <h4>Pharmacovigilance and Safety Surveillance</h4> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div class="row-fluid-wrapper row-depth-1 row-number-13 dnd-section"> <div class="row-fluid "> <div class="span12 widget-span widget-type-cell dnd-column" style="" data-widget-type="cell" data-x="0" data-w="12"> <div class="row-fluid-wrapper row-depth-1 row-number-14 dnd-row"> <div class="row-fluid "> <div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> <div id="hs_cos_wrapper_widget_1647529353678" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> <div id="" class="hhs-text-mod lazy-background show-mobile show-tablet show-desktop "><div class="container " style=""> <div class="row"> <div class="c1 col-sm-12 none "> <div class="col-inner"> <div class="hhs-rich-text-in"> <div class="hhs-rich-text"> <h4 style="text-align: left;">Post-Marketing Pharmacovigilance and Safety Monitoring</h4> <p style="text-align: left;"><span>While it is critical to ensure patient safety throughout clinical trial planning, execution, and the regulatory approval process, it doesn’t end there. Once a therapeutic receives regulatory approval, long-term safety monitoring begins to ensure continued patient safety.</span><br><br><span>We can help you develop, negotiate, and implement your Risk Management Plans with the regulatory agencies. The process begins during the preparation of the marketing application (e.g., NDA, NDS, BLA, etc.) and continues post-approval for the entire time the product/therapeutic is on the market.  <br></span></p> <p style="text-align: left;"><a href="/pharmacovigilance" rel="noopener" target="_blank">> LEARN MORE ABOUT PHARMACOVIGILANCE AND SAFETY MONITORING </a></p> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div class="row-fluid-wrapper row-depth-1 row-number-15 dnd-section"> <div class="row-fluid "> <div class="span12 widget-span widget-type-cell dnd-column" style="" data-widget-type="cell" data-x="0" data-w="12"> <div class="row-fluid-wrapper row-depth-1 row-number-16 dnd-row"> <div class="row-fluid "> <div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> <div id="hs_cos_wrapper_widget_1647529622551" class="hs_cos_wrapper hs_cos_wrapper_widget 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