{"id":3898,"date":"2022-10-18T09:22:56","date_gmt":"2022-10-18T01:22:56","guid":{"rendered":"https:\/\/regask.com\/?p=3898"},"modified":"2024-11-22T05:20:25","modified_gmt":"2024-11-21T21:20:25","slug":"guias-de-ensayos-clinicos-descentralizados","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/decentralized-clinical-trials-guidebooks\/","title":{"rendered":"Las gu\u00edas regulatorias allanaron el camino para la criptomoneda descentralizada"},"content":{"rendered":"<p><span data-contrast=\"none\">La adopci\u00f3n de ensayos cl\u00ednicos h\u00edbridos y descentralizados (DCT) se ha acelerado en todo el mundo. Seg\u00fan Everest Group, <\/span><a href=\"https:\/\/www.obviohealth.com\/resources\/a-look-ahead-decentralized-clinical-trials-in-2023\"><span data-contrast=\"none\">90% de la industria incorporar\u00e1 algunos componentes DCT para sus ensayos cl\u00ednicos en 2024<\/span><\/a><span data-contrast=\"none\">Sin embargo, tambi\u00e9n han aumentado los desaf\u00edos para los patrocinadores y las organizaciones de investigaci\u00f3n por contrato (CRO) para llevar a cabo con \u00e9xito las DCT. Uno de los desaf\u00edos clave es acceder a las regulaciones y comprenderlas.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:false,&quot;201341983&quot;:2,&quot;335559739&quot;:240,&quot;335559740&quot;:330}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">El panorama regulatorio que rodea la implementaci\u00f3n de las DCT es complejo y fragmentado. Las regulaciones de las DCT evolucionan con cambios constantes y var\u00edan de un pa\u00eds a otro. Sin embargo, a\u00fan no se ha desarrollado una gu\u00eda regulatoria global consolidada sobre el panorama de las DCT, lo que genera muchas incertidumbres y posibles demoras en la implementaci\u00f3n de los ensayos.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:false,&quot;201341983&quot;:2,&quot;335559739&quot;:240,&quot;335559740&quot;:330}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">Para ayudar a los patrocinadores y a las CRO a superar los desaf\u00edos, RegASK ha desarrollado una serie de gu\u00edas regulatorias de ensayos cl\u00ednicos que abarcan 24 pa\u00edses y que brindan informaci\u00f3n vital y validada sobre el marco regulatorio actual de los ensayos cl\u00ednicos, con un an\u00e1lisis profundo de los elementos de los ensayos cl\u00ednicos y sus matices. La informaci\u00f3n de las gu\u00edas se presenta en una biblioteca digital f\u00e1cil de comprender que permite a los lectores comprender el marco regulatorio general de los ensayos cl\u00ednicos y los componentes de los ensayos cl\u00ednicos de una manera m\u00e1s r\u00e1pida y sencilla.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:false,&quot;201341983&quot;:2,&quot;335559739&quot;:240,&quot;335559740&quot;:330}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"none\">Lea el estudio de caso y conozca c\u00f3mo las Gu\u00edas de RegASK ayudan a las CRO en todos los aspectos regulatorios de los ensayos cl\u00ednicos h\u00edbridos o descentralizados para una implementaci\u00f3n de ensayos eficiente y exitosa.\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:240,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<h2 class=\"h4\"><strong>Objetivo<\/strong><\/h2>\n<p><span data-contrast=\"none\">Una CRO global especializada en ensayos cl\u00ednicos virtuales ha estado brindando soluciones DCT habilitadas tecnol\u00f3gicamente a patrocinadores de ensayos cl\u00ednicos en todo el mundo. <\/span><span data-contrast=\"none\">Yo<\/span><span data-contrast=\"none\">Cuando planean registrar un DCT en un nuevo pa\u00eds o utilizar soluciones tecnol\u00f3gicas dentro de un ensayo cl\u00ednico, surgen cuestiones regulatorias y a menudo se convierten en un bloqueador que retrasa el ensayo.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">Para guiar la implementaci\u00f3n del ensayo, el equipo estuvo recopilando manualmente informaci\u00f3n regulatoria de los reguladores del DCT en diferentes pa\u00edses, lo cual requiere mucho tiempo, es desorganizado e insuficiente para responder todas sus preguntas relacionadas con el registro y la ejecuci\u00f3n del ensayo.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559739&quot;:240,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">La CRO buscaba un servicio regulatorio integral que pudiera brindar informaci\u00f3n completa y exhaustiva sobre el panorama regulatorio global de DCT para guiar mejor a sus clientes en la ejecuci\u00f3n de estudios cl\u00ednicos y ayudarlos a mejorar la eficiencia de los ensayos cl\u00ednicos.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:312,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<h2 class=\"h4\"><strong>Soluci\u00f3n<\/strong><\/h2>\n<ul>\n<li><span class=\"TextRun SCXW65571966 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW65571966 BCX0\">RegASK-d<\/span><span class=\"NormalTextRun SCXW65571966 BCX0\">Se desarrollaron gu\u00edas detalladas que destacan todos los aspectos de los requisitos regulatorios para implementar ensayos cl\u00ednicos h\u00edbridos o completamente descentralizados en <\/span><span class=\"NormalTextRun SCXW65571966 BCX0\">encima <\/span><span class=\"NormalTextRun SCXW65571966 BCX0\">3<\/span><span class=\"NormalTextRun SCXW65571966 BCX0\">0<\/span><span class=\"NormalTextRun SCXW65571966 BCX0\"> Mercados que cubren Asia, LATAM, UE<\/span><span class=\"NormalTextRun SCXW65571966 BCX0\">,<\/span><span class=\"NormalTextRun SCXW65571966 BCX0\"> y Am\u00e9rica del Norte<\/span><span class=\"NormalTextRun SCXW65571966 BCX0\">. <\/span><\/span>Las gu\u00edas digitales cubren la informaci\u00f3n de extremo a extremo necesaria para construir una estrategia de DCT, desde la importaci\u00f3n de muestras de investigaci\u00f3n, la ubicaci\u00f3n y los requisitos de calificaci\u00f3n de los investigadores, el consentimiento electr\u00f3nico, la firma electr\u00f3nica, el ePRO, las visitas del HHCP hasta la verificaci\u00f3n y validaci\u00f3n de los protocolos de almacenamiento de datos y las regulaciones de transferencia de datos.<\/li>\n<\/ul>\n<ul>\n<li><span data-contrast=\"none\">RegASK elabor\u00f3 una descripci\u00f3n general de los requisitos de cada pa\u00eds para el registro de estudios cl\u00ednicos digitales y dise\u00f1\u00f3 una hoja de ruta para el proceso de presentaci\u00f3n.\u00a0<\/span><\/li>\n<li>Las Gu\u00edas se actualizan constantemente a trav\u00e9s de la soluci\u00f3n de inteligencia y monitoreo continuo de RegASK: la <a href=\"https:\/\/regask.com\/es\/our-solution\/\"><span data-contrast=\"none\">Alerta de registro<\/span><\/a><span data-contrast=\"none\"> plataforma.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:144,&quot;335559740&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n<h2 class=\"h4\"><strong>Resultados<\/strong><\/h2>\n<p><span class=\"TextRun SCXW21309744 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW21309744 BCX0\">El <\/span><span class=\"NormalTextRun SCXW21309744 BCX0\">CRO<\/span> <span class=\"NormalTextRun SCXW21309744 BCX0\">Ganado<\/span> <span class=\"NormalTextRun SCXW21309744 BCX0\">claridad en<\/span><span class=\"NormalTextRun SCXW21309744 BCX0\"> las regulaciones relacionadas con <\/span><span class=\"NormalTextRun SCXW21309744 BCX0\">D<\/span><span class=\"NormalTextRun SCXW21309744 BCX0\">Registro CT<\/span><span class=\"NormalTextRun SCXW21309744 BCX0\"> y <\/span><span class=\"NormalTextRun SCXW21309744 BCX0\">implementaci\u00f3n, <\/span><span class=\"NormalTextRun SCXW21309744 BCX0\">Permiti\u00e9ndoles planificar y <\/span><span class=\"NormalTextRun SCXW21309744 BCX0\">Implementar DCT en<\/span> <span class=\"NormalTextRun SCXW21309744 BCX0\">3<\/span><span class=\"NormalTextRun SCXW21309744 BCX0\">0<\/span><span class=\"NormalTextRun SCXW21309744 BCX0\"> pa\u00edses y <\/span><span class=\"NormalTextRun SCXW21309744 BCX0\">Adem\u00e1s, les ahorra cientos de horas de investigaci\u00f3n regulatoria y aumenta significativamente la eficiencia de sus ensayos.\u00a0<\/span><\/span><span class=\"EOP SCXW21309744 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:144,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: center;\" data-line-height=\"xs\">\u00bfNecesita apoyo regulatorio sobre DCT?<\/h2>\n<h2 style=\"text-align: center;\" data-line-height=\"xs\">Hable con nuestros expertos<\/h2>\n<p style=\"text-align: center;\">O tambi\u00e9n puedes enviarnos un WhatsApp haciendo clic en este n\u00famero\u00a0<a href=\"https:\/\/wa.me\/+6581282161?text=I%27m%20interested%20in%20RegASK%20solution\">+65 8128 2161<\/a><\/p>\n\n\t<section class=\"section\" id=\"section_1720957474\">\n\t\t<div class=\"section-bg fill\" >\n\t\t\t\t\t\t\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n\n<div class=\"row\"  id=\"row-2017137762\">\n\n\n\t<div id=\"col-259263001\" class=\"col medium-10 small-12 large-10\"  >\n\t\t\t\t<div class=\"col-inner text-center\"  >\n\t\t\t\n\t\t\t\n\n\n\n<script charset=\"utf-8\" type=\"text\/javascript\" src=\"\/\/js.hsforms.net\/forms\/embed\/v2.js\"><\/script>\n<script>\n  hbspt.forms.create({\n    region: \"na1\",\n    portalId: \"20908020\",\n    formId: \"0af2c091-f9d4-497e-812e-14d3abddf395\"\n  });\n<\/script>\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1720957474 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  background-color: rgb(242,246,253);\n}\n<\/style>\n\t<\/section>","protected":false},"excerpt":{"rendered":"<p>La adopci\u00f3n de ensayos cl\u00ednicos h\u00edbridos y descentralizados (ECD) se ha acelerado a nivel mundial. Seg\u00fan Everest Group, el 90% de la industria incorporar\u00e1 algunos componentes de ECD en sus ensayos cl\u00ednicos para 2024. Sin embargo, tambi\u00e9n han aumentado los desaf\u00edos para los patrocinadores y las Organizaciones de Investigaci\u00f3n por Contrato (CRO) para llevar a cabo ECD con \u00e9xito. Una de las claves\u2026<\/p>","protected":false},"author":39,"featured_media":3913,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[17,22],"tags":[],"class_list":["post-3898","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-study","category-medical-devices"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Decentralized Clinical Trials Guidebooks | RegASK<\/title>\n<meta name=\"description\" content=\"Regulatory guidebooks are paving the way for decentralized clinical trials. Learn more about this trend with RegASK.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/es\/guias-de-ensayos-clinicos-descentralizados\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Regulatory Guidebooks Paved the Way for Decentralized Clinical Trials\u00a0\" \/>\n<meta property=\"og:description\" content=\"Regulatory guidebooks are paving the way for decentralized clinical trials. Learn more about this trend with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/guias-de-ensayos-clinicos-descentralizados\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2022-10-18T01:22:56+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-21T21:20:25+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2022\/10\/Regulatory-Guidebooks-Paved-the-Way-for-Decentralized-Clinical-Trials.png\" \/>\n\t<meta property=\"og:image:width\" content=\"331\" \/>\n\t<meta property=\"og:image:height\" content=\"301\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/decentralized-clinical-trials-guidebooks\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/decentralized-clinical-trials-guidebooks\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"Regulatory Guidebooks Paved the Way for Decentralized C&hellip;\",\"datePublished\":\"2022-10-18T01:22:56+00:00\",\"dateModified\":\"2024-11-21T21:20:25+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/decentralized-clinical-trials-guidebooks\\\/\"},\"wordCount\":519,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/decentralized-clinical-trials-guidebooks\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2022\\\/10\\\/Regulatory-Guidebooks-Paved-the-Way-for-Decentralized-Clinical-Trials.png\",\"articleSection\":[\"Case Studies\",\"Medical Devices\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/decentralized-clinical-trials-guidebooks\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/decentralized-clinical-trials-guidebooks\\\/\",\"name\":\"Decentralized Clinical Trials Guidebooks | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/decentralized-clinical-trials-guidebooks\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/decentralized-clinical-trials-guidebooks\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2022\\\/10\\\/Regulatory-Guidebooks-Paved-the-Way-for-Decentralized-Clinical-Trials.png\",\"datePublished\":\"2022-10-18T01:22:56+00:00\",\"dateModified\":\"2024-11-21T21:20:25+00:00\",\"description\":\"Regulatory guidebooks are paving the way for decentralized clinical trials. 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