{"id":12376,"date":"2022-09-22T09:57:24","date_gmt":"2022-09-22T07:57:24","guid":{"rendered":"https:\/\/okomeds.com\/?p=12376\/"},"modified":"2022-09-22T09:57:24","modified_gmt":"2022-09-22T07:57:24","slug":"how-europes-rules-for-clinical-trials-are-changing","status":"publish","type":"post","link":"https:\/\/okomeds.com\/es\/how-europes-rules-for-clinical-trials-are-changing\/","title":{"rendered":"How Europe\u2019s rules for clinical trials are changing"},"content":{"rendered":"<p>The new European clinical trial regulations are a great opportunity for <a href=\"https:\/\/okomeds.com\/translation-cro-2\/\" target=\"_blank\" rel=\"noopener noreferrer\">CROs<\/a> and companies involved in clinical research. Our medical translation agency wants to share with you how the new Clinical Trials Information System will help centralise processes and streamline studies.<\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_81 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Alternar tabla de contenidos\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/okomeds.com\/es\/how-europes-rules-for-clinical-trials-are-changing\/#Excellence_in_clinical_trials\" >Excellence in clinical trials<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/okomeds.com\/es\/how-europes-rules-for-clinical-trials-are-changing\/#Use_of_a_centralised_platform\" >Use of a centralised platform<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"Excellence_in_clinical_trials\"><\/span><strong>Excellence in clinical trials<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>One of the main objectives of the <strong>European regulations on clinical trials<\/strong> is achieving excellence in this type of work. Indeed, this can be the foundation for a strong biomedical research ecosystem, which will also boost basic and pre-clinical research and help European countries become leaders in medical research.<\/p>\n<p>Specifically, the new Clinical Trials Information System harmonises the processes for the submission, assessment and monitoring of clinical trials. The aim? <strong>To speed up these studies and, as a result, to get new, effective and safe medicines more quickly to the people who need them.<\/strong><\/p>\n<p>Thanks to this procedure, clinical trial sponsors will now be able to apply for authorisation for a trial simultaneously in all EU countries. They will have to do this through a single application that results in submissions to the competent national authorities, ethics committees and public registration of the clinical trial.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Use_of_a_centralised_platform\"><\/span><strong>Use of a centralised platform<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The <strong>European Medicines Agency (EMA)<\/strong> has requested that clinical trial applications be submitted through this system now. However, there is a timeframe to adapt to the new system. As of 31 January 2023, clinical research companies will have to use the new central platform. All study information will have to be fully transferred to this system by 2025.<\/p>\n<p>Clinical trials not only offer new hope for patients, but also <strong>have very positive financial consequences for the healthcare system<\/strong>. They attract funding from the sponsoring pharmaceutical companies which goes to the participating hospitals, both public and private, and they are the leading source of private income for these centres. In addition, they improve the reputation, experience and knowledge of the healthcare professionals involved in running them, placing them at the cutting edge of science, which they can then apply in their healthcare work. If in addition we consider the process of medical translation to disseminate research advances, the result is spectacular.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The new European clinical trial regulations are a great opportunity for CROs and companies involved in clinical research. Our medical translation agency wants to share with you how the new Clinical Trials Information System will help centralise processes and streamline studies. Excellence in clinical trials&#8230;<\/p>\n","protected":false},"author":13,"featured_media":12389,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[5,6],"tags":[],"class_list":["post-12376","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-clinical-research","category-medical-translations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>How Europe\u2019s rules for clinical trials are changing - Okomeds<\/title>\n<meta name=\"description\" content=\"Find out more about the new regulations affecting clinical trials and how they will impact on companies.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/okomeds.com\/how-europes-rules-for-clinical-trials-are-changing\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How Europe\u2019s rules for clinical trials are changing - 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