{"id":5073,"date":"2022-05-31T03:32:23","date_gmt":"2022-05-31T07:32:23","guid":{"rendered":"https:\/\/clariowebstg.wpengine.com\/?page_id=5073"},"modified":"2025-11-10T11:45:09","modified_gmt":"2025-11-10T16:45:09","slug":"regulatory-consultation-and-statistical-analysis-expertise","status":"publish","type":"solutions","link":"https:\/\/clario.com\/solutions\/cardiac-solutions\/regulatory-consultation-and-statistical-analysis-expertise\/","title":{"rendered":"Regulatory Consultation and Statistical Analysis Expertise"},"content":{"rendered":"<div class=\"clario-anchor-navigation sticky-top \">\n  <div class=\"container\">\n    <div class=\"row\">\n      <a href=\"#overview\" class=\"button active nav-link col-auto\">Overview<\/a><a href=\"#detail\" class=\"button nav-link col-auto\">Detail<\/a><a href=\"#resources\" class=\"button nav-link col-auto\">Resources<\/a>            <button class=\"control arrow closed\" aria-label=\"Toggle\"><\/button>\n    <\/div>\n  <\/div>\n<\/div>\n\n<script type=\"text\/javascript\">\n  jQuery(window).on(\"load\", function() {\n    Clario.AnchorNavigation.run();\n  });\n<\/script>\n\n\n<div class=\"clario-section\">\n  <div class=\"container\">\n      \n<div class=\"row\">\n\t\n\n<div class=\"col-12 col-md-9\">\n\t\t\t\n\n<p id=\"overview\">Our in-house cardiac science team optimizes clinical trial protocol design, maximizing data accuracy and reducing portfolio risks. They have worked with regulatory authorities for decades and have a thorough understanding of what methodologies and processes should be employed to ensure quality outcomes, and as a result, can guide drug development through cardiac safety regulatory requirements.<\/p>\n\n\n\n<p id=\"overview\">Our consulting services include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Expert protocol development and study design<\/li>\n\n\n\n<li>Statistical analysis, including concentration QTc analysis&nbsp;<\/li>\n\n\n\n<li>Authoring expert cardiac safety reports; support for Thorough QT Study waivers<\/li>\n\n\n\n<li>Regulatory strategy advice and support for health authority interactions<\/li>\n<\/ul>\n\n\t<\/div>\n\n<\/div>\n\n  <\/div>\n<\/div>\n\n\n<div class=\"clario-section light-grey-50\">\n  <div class=\"container\">\n      \n<div class=\"row mb-2\">\n\t\n\n<div class=\"col-12 col-md-9\">\n\t\t\t\n\n<h2 class=\"wp-block-heading\" id=\"detail\">Product detail<\/h2>\n\n\t<\/div>\n\n<\/div>\n\n\n<div class=\"row align-items-start\">\n\t\n\n<div class=\"col-12 col-md-9\">\n\t\t\t\n\n<h3 class=\"wp-block-heading\" id=\"h-regulatory-consulting\">Regulatory Consulting<\/h3>\n\n\n\n<p>Avoid safety and regulatory issues long before they become critical with strategic protocol and study design advice&nbsp;for early- and late-phase studies. Our consulting team can also help you determine the best devices and integrated solution and select the best strategy for analyzing cardiac endpoints.<\/p>\n\n\t<\/div>\n\n<\/div>\n\n\n\n<hr class=\"wp-block-separator has-css-opacity mb-3\"\/>\n\n\n<div class=\"row align-items-start\">\n\t\n\n<div class=\"col-12 col-md-9\">\n\t\t\t\n\n<h3 class=\"wp-block-heading\" id=\"h-statistical-analysis-expertise\">Statistical Analysis Expertise<\/h3>\n\n\n\n<p>A team of biostatisticians and statistical programmers with expertise in cardiac safety analysis methodologies facilitate clinical trials through all phases of development.&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Developed tailored cardiac safety analysis plans designed to meet sponsor needs and study design considerations<\/li>\n\n\n\n<li>Expertise in the analysis of all types of cardiac safety data: QT interval data, ECG morphologic evaluations, continuous Holter \/ Patch arrhythmia data, 24-hour ambulatory blood pressure data, heart rate variability<\/li>\n\n\n\n<li>Creation of CDISC compliant analysis datasets for global regulatory submission, including electronic submission deliverable packages<\/li>\n<\/ul>\n\n\t<\/div>\n\n<\/div>\n\n  <\/div>\n<\/div>\n\n\n<div class=\"clario-section d-none\">\n  <div class=\"container\">\n      \n\n<h2 class=\"wp-block-heading\" id=\"resources\">Related resources<\/h2>\n\n\n  <div class=\"clario-collection clario-collection-select row  clario-collection-count-0\">\n            <div class=\"col-12 no-more-found\"><p>No results found.<\/p><\/div>        <\/div>\n\n  <\/div>\n<\/div>\n\n\n<div class=\"clario-section\">\n  <div class=\"container\">\n      \n<div class=\"row\">\n\t\n\n<div class=\"col-12 col-md-12\">\n\t\t\t\n\n<h2 class=\"wp-block-heading\" id=\"h-related-solutions\">Related solutions<\/h2>\n\n\n<div class=\"clario-collection clario-collection-summary clario-collection-resources clario-collection-type-solution row \"><article class=\"col-12 col-md-6 col-xl-4\">\n<a href=\"https:\/\/clario.com\/solutions\/cardiac-solutions\/arrhythmia\/\" class=\"clario-solution-thumb\">\n  <img loading=\"lazy\" decoding=\"async\" width=\"545\" height=\"265\" src=\"https:\/\/clario.com\/wp-content\/uploads\/2022\/05\/arrhythmia-featured.png\" class=\"attachment-medium size-medium wp-post-image\" alt=\"arrhythmia-featured\" \/>  <h3 class=\"clario-thumb-title\">Arrhythmia Analysis<\/h3>\n  <p>Collect continuous ECG data with certainty in site-based or decentralized clinical trials with our flexible technology solutions and patient-friendly devices.<\/p>\n  <span class=\"clario-thumb-link button primary\">Find out more<\/span>\n<\/a>\n      <\/article><article class=\"col-12 col-md-6 col-xl-4\">\n<a href=\"https:\/\/clario.com\/solutions\/cardiac-solutions\/blood-pressure-services\/\" class=\"clario-solution-thumb\">\n  <img loading=\"lazy\" decoding=\"async\" width=\"545\" height=\"265\" src=\"https:\/\/clario.com\/wp-content\/uploads\/2022\/11\/blood-pressure-featured.png\" class=\"attachment-medium size-medium wp-post-image\" alt=\"blood-pressure-featured\" \/>  <h3 class=\"clario-thumb-title\">Blood Pressure Services<\/h3>\n  <p>Collect and centrally analyze accurate, consistent, quality blood pressure data from site-based to decentralized trials.<\/p>\n  <span class=\"clario-thumb-link button primary\">Find out more<\/span>\n<\/a>\n      <\/article><article class=\"col-12 col-md-6 col-xl-4\">\n<a href=\"https:\/\/clario.com\/solutions\/cardiac-solutions\/ecg-phase-i-through-iv\/\" class=\"clario-solution-thumb\">\n  <img loading=\"lazy\" decoding=\"async\" width=\"545\" height=\"265\" src=\"https:\/\/clario.com\/wp-content\/uploads\/2022\/11\/ECG-featured.png\" class=\"attachment-medium size-medium wp-post-image\" alt=\"ECG-featured\" \/>  <h3 class=\"clario-thumb-title\">ECG \u2014 On-site to DCT and Phase I-IV<\/h3>\n  <p>Monitor every heartbeat with precision from anywhere to assess safety and efficacy throughout your site-based or decentralized clinical trial.<\/p>\n  <span class=\"clario-thumb-link button primary\">Find out more<\/span>\n<\/a>\n      <\/article><article class=\"col-12 col-md-6 col-xl-4\">\n<a href=\"https:\/\/clario.com\/solutions\/cardiac-solutions\/phase-i-tqt-cardiac-assessment\/\" class=\"clario-solution-thumb\">\n  <img loading=\"lazy\" decoding=\"async\" width=\"545\" height=\"265\" src=\"https:\/\/clario.com\/wp-content\/uploads\/2022\/11\/TQT-featured.png\" class=\"attachment-medium size-medium wp-post-image\" alt=\"TQT-featured\" \/>  <h3 class=\"clario-thumb-title\">Phase I\/TQT Cardiac Assessment<\/h3>\n  <p>Fulfill your ICH E14 requirement early, minimize risk and potentially reduce costs throughout your trial by collaborating with our Phase 1 Center of Excellence.<\/p>\n  <span class=\"clario-thumb-link button primary\">Find out more<\/span>\n<\/a>\n      <\/article>  <\/div>\n\t<\/div>\n\n<\/div>\n\n  <\/div>\n<\/div>\n\n\n<div class=\"clario-section clario-cta clario-cta-layout-standard  purple show-bg-pixel \" id=customer >\n  <div class=\"container\">\n    <div class=\"row align-items-md-center\">\n        <div class=\"clario-cta-content col-md-6 offset-md-1 col-10\"><p class=\"h2\">Learn more or speak with one our experts<\/p><p><p>Our team of clinical trial cardiac solution experts is always available to address any questions you may have about our cardiac solutions. Submit your contact information and we\u2019ll be in touch shortly.<\/p>\n<\/p><\/div><div class=\"cta-buttons offset-md-1 col-md-4 col-10\"><div class=\"clario-cta-action\"><a href=\"#popup-1\" class=\"button cta-1 \">Get started<\/a><\/div><\/div>    <\/div>\n  <\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Leverage our industry key opinion leaders to understand the complex regulatory landscape while minimizing risk with confidence. [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/clario.com\/solutions\/cardiac-solutions\/regulatory-consultation-and-statistical-analysis-expertise\/\">Read More&#8230;<span class=\"screen-reader-text\"> from Regulatory Consultation and Statistical Analysis Expertise<\/span><\/a><\/p>\n","protected":false},"featured_media":7027,"parent":5034,"menu_order":5,"template":"","tags":[121],"class_list":["post-5073","solutions","type-solutions","status-publish","has-post-thumbnail","hentry","tag-solutions"],"acf":[],"cp_meta_data":{"page_title":[""],"_page_title":["field_615dbd9cfca50"],"banner_image":["5214"],"_banner_image":["field_614c580034347"],"introduction":["Leverage our industry key opinion leaders to understand the complex regulatory landscape while minimizing risk with confidence."],"_introduction":["field_614c581e34348"],"_yoast_wpseo_focuskeywords":["[{\"keyword\":\"clinical trials\",\"score\":93},{\"keyword\":\"clinical trial 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