{"id":8619,"date":"2025-10-20T10:55:34","date_gmt":"2025-10-20T10:55:34","guid":{"rendered":"https:\/\/mdxcro.com\/mdx-cro-en-esmo-2025-berlin-avanzando-en-las-transiciones-de-ivdr-y-los-ensayos-clinicos-combinados\/"},"modified":"2026-07-28T13:32:41","modified_gmt":"2026-07-28T13:32:41","slug":"mdx-cro-en-esmo-2025-berlin-avanzando-en-las-transiciones-de-ivdr-y-los-ensayos-clinicos-combinados","status":"publish","type":"post","link":"https:\/\/mdxcro.com\/es\/mdx-cro-en-esmo-2025-berlin-avanzando-en-las-transiciones-de-ivdr-y-los-ensayos-clinicos-combinados\/","title":{"rendered":"MDx CRO en ESMO 2025 (Berl\u00edn): avanzando en las transiciones de IVDR y los ensayos cl\u00ednicos combinados"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">MDx CRO present\u00f3 nuevas pruebas y aprendizajes pr\u00e1cticos en <strong><a href=\"https:\/\/www.esmo.org\/\">ESMO 2025<\/a><\/strong> que refuerzan nuestra posici\u00f3n como el socio preferido para las <strong>transiciones IVDR<\/strong> y los <strong>ensayos cl\u00ednicos combinados<\/strong> que involucran IVD en investigaci\u00f3n. Fuimos <strong>primer autor<\/strong> en un p\u00f3ster con <strong>Fulgent Genetics<\/strong> y <strong>colaboradores<\/strong> en un p\u00f3ster de <strong>Servier<\/strong>, ambos centrados en las realidades operativas y regulatorias de llevar diagn\u00f3sticos oncol\u00f3gicos de alto impacto a la pr\u00e1ctica cl\u00ednica bajo el IVDR de la UE.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Aspectos destacados de nuestros p\u00f3steres de ESMO 2025<\/h2>\n\n\n\n<h4 class=\"wp-block-heading has-white-frost-color has-blue-background-color has-text-color has-background has-link-color wp-elements-1\">Fulgent genetics &amp; MDx CRO \u2014 <em>MDx CRO primer autor<\/em><\/h4>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>T\u00edtulo: <em>Retos del cumplimiento del IVDR en la certificaci\u00f3n de un panel NGS a gran escala para c\u00e1ncer hereditario<\/em><\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Lo que cubre:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Plan pr\u00e1ctico para la transici\u00f3n de un <strong>panel NGS integral de c\u00e1ncer hereditario<\/strong> basado en servicios bajo <strong>IVDR<\/strong>.<\/li>\n\n\n\n<li>Definici\u00f3n del uso previsto y la validez cient\u00edfica en un gran conjunto de genes; <strong>documentaci\u00f3n t\u00e9cnica<\/strong> integral; <strong>validaci\u00f3n bioinform\u00e1tica<\/strong> alineada con IEC 62304\/82304; y estrategia de participaci\u00f3n del organismo notificado.<\/li>\n\n\n\n<li>Lecciones sobre la verificaci\u00f3n\/validaci\u00f3n del tama\u00f1o correcto y la creaci\u00f3n de un paquete de evidencia vivo para respaldar el marcado CE.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Por qu\u00e9 es importante:<\/strong> Los sponsors y los desarrolladores de laboratorio obtienen una ruta pr\u00e1ctica para trasladar los servicios NGS complejos al cumplimiento de IVDR, sin ralentizar los programas cl\u00ednicos.<\/p>\n\n\n\n<figure class=\"wp-block-gallery has-nested-images columns-default is-cropped wp-block-gallery-1 is-layout-flex wp-block-gallery-is-layout-flex\">\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1600\" height=\"900\" data-id=\"8651\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/10\/20251019_1244261-1-1-1600x900.jpg\" alt=\"MDx CRO en ESMO 2025 en Berl\u00edn presentando un p\u00f3ster sobre el cumplimiento del IVDR para paneles grandes de NGS para pruebas de enfermedades de la l\u00ednea germinal con Fulgent Genetics\" class=\"wp-image-8651\" srcset=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/10\/20251019_1244261-1-1-1600x900.jpg 1600w, https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/10\/20251019_1244261-1-1-1067x600.jpg 1067w, https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/10\/20251019_1244261-1-1-768x432.jpg 768w, https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/10\/20251019_1244261-1-1-1536x864.jpg 1536w, https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/10\/20251019_1244261-1-1-2048x1152.jpg 2048w\" sizes=\"(max-width: 1600px) 100vw, 1600px\" \/><figcaption class=\"wp-element-caption\"><strong>Dra. Marketa Svobodova, directora de Medicina de Precisi\u00f3n, y Carlos Galamba, CEO de MDx \u2013 Presentaci\u00f3n de p\u00f3ster en ESMO 2025 en Berl\u00edn<\/strong><\/figcaption><\/figure>\n<\/figure>\n\n\n\n<h4 class=\"wp-block-heading has-white-frost-color has-blue-background-color has-text-color has-background has-link-color wp-elements-2\">Servier &amp; MDx CRO (estudio CHONQUER) \u2014 <em>Colaborador de MDx CRO<\/em><\/h4>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>T\u00edtulo:  <em>Navegando por la complejidad regulatoria en estudios combinados bajo el CTR y el IVDR (<a href=\"https:\/\/clinicaltrials.servier.com\/trial\/NCT06127407\/ivosidenib-in-participants-with-locally-advanced-or-metastatic-conventional-chondrosarcoma-untreated-or-previously-treated-with-1-systemic-treatment-regimen-chonquer\">CHONQUER<\/a>)<\/em><\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Lo que cubre:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>C\u00f3mo <strong>los ensayos combinados<\/strong> (f\u00e1rmaco + IVD en investigaci\u00f3n) desencadenan una doble supervisi\u00f3n bajo <strong>CTR<\/strong> e <strong>IVDR<\/strong> y los efectos indirectos para <strong>los plazos, las presentaciones y la activaci\u00f3n del sitio<\/strong> en todos los estados miembros de la UE.<\/li>\n\n\n\n<li>Patrones operativos que aceleran las aprobaciones: planificaci\u00f3n temprana de CPS, documentaci\u00f3n consolidada y estrategias alineadas de \u00e9tica\/autoridad competente.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Por qu\u00e9 es importante:<\/strong> Los sponsors de oncolog\u00eda pueden reducir el riesgo de los programas globales anticipando los requisitos espec\u00edficos de IVDR y asoci\u00e1ndose con una IVD CRO que haya trabajado en ambos lados de la cerca.<\/p>\n\n\n\n<figure class=\"wp-block-gallery has-nested-images columns-default is-cropped wp-block-gallery-2 is-layout-flex wp-block-gallery-is-layout-flex\">\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1600\" height=\"901\" data-id=\"8655\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/10\/20251019_085852-1-1600x901.jpg\" alt=\"MDx CRO present\u00f3 un p\u00f3ster en ESMO 2025 (Berl\u00edn) sobre estudios cl\u00ednicos combinados de CTR + IVDR con Servier.\" class=\"wp-image-8655\" srcset=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/10\/20251019_085852-1-1600x901.jpg 1600w, https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/10\/20251019_085852-1-1066x600.jpg 1066w, https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/10\/20251019_085852-1-768x432.jpg 768w, https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/10\/20251019_085852-1-1536x865.jpg 1536w, https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/10\/20251019_085852-1-2048x1153.jpg 2048w\" sizes=\"(max-width: 1600px) 100vw, 1600px\" \/><figcaption class=\"wp-element-caption\"><strong>Dra. Marketa Svobodova, directora de Medicina de Precisi\u00f3n de MDx \u2013 Presentaci\u00f3n de p\u00f3ster en ESMO 2025 \u2013 Estudio CHONQUER, un estudio combinado bajo IVDR\/CTR<\/strong><\/figcaption><\/figure>\n<\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">Conclusiones clave para los sponsors<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Transiciones de IVDR, de principio a fin.<\/strong> MDx CRO apoya la estrategia de dosier, los estudios de rendimiento cl\u00ednico (ISO 20916), la validez cient\u00edfica y la participaci\u00f3n del organismo notificado para el marcado CE.<\/li>\n\n\n\n<li><strong>Ensayos combinados, simplificados.<\/strong> Dise\u00f1amos y ejecutamos estudios de CPS y CTR + IVDR combinados, armonizando las presentaciones en carteras de varios pa\u00edses.<\/li>\n\n\n\n<li><strong>Operaciones listas para oncolog\u00eda.<\/strong> Profunda experiencia con la preselecci\u00f3n molecular, los flujos de trabajo de NGS y la coordinaci\u00f3n f\u00e1rmaco-dispositivo para la oncolog\u00eda de precisi\u00f3n.<\/li>\n<\/ul>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"has-regular-font-size wp-block-paragraph\">\u00bfNecesita una sesi\u00f3n informativa r\u00e1pida? <a href=\"https:\/\/mdxcro.com\/es\/contacto\/\">P\u00f3ngase en contacto<\/a> con nuestro equipo de IVD CRO para obtener una explicaci\u00f3n de c\u00f3mo estos hallazgos se traducen en su transici\u00f3n de IVDR o plan de estudio combinado.<\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\">Preguntas frecuentes<\/h2>\n\n\n\n<div class=\"schema-faq wp-block-yoast-faq-block\"><div class=\"schema-faq-section\" id=\"faq-question-1760950807805\"><strong class=\"schema-faq-question\"><em>\u00bfQu\u00e9 hace MDx CRO para las transiciones de IVDR?<\/em><\/strong> <p class=\"schema-faq-answer\">Brindamos soporte integral, desde la definici\u00f3n del uso previsto y la validez cient\u00edfica hasta los estudios de rendimiento cl\u00ednico, la documentaci\u00f3n t\u00e9cnica y la participaci\u00f3n del organismo notificado.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1760950835211\"><strong class=\"schema-faq-question\">\u00bfC\u00f3mo apoya MDx CRO los estudios combinados CTR + IVDR?<\/strong> <p class=\"schema-faq-answer\">Planificamos y ejecutamos CPS y ensayos combinados, consolidando las presentaciones y alineando los requisitos de \u00e9tica\/autoridad competente para reducir los retrasos.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1760957637397\"><strong class=\"schema-faq-question\">\u00bfPuede MDx CRO ayudar con la validaci\u00f3n del panel NGS bajo IVDR?<\/strong> <p class=\"schema-faq-answer\">S\u00ed. Dise\u00f1amos programas de verificaci\u00f3n\/validaci\u00f3n del tama\u00f1o correcto y validaci\u00f3n bioinform\u00e1tica alineada con IEC 62304\/82304. <\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1760957664355\"><strong class=\"schema-faq-question\">\u00bfD\u00f3nde puedo obtener los p\u00f3steres de ESMO 2025?<\/strong> <p class=\"schema-faq-answer\">Ambos PDF est\u00e1n disponibles en la plataforma ESMO; p\u00f3ngase en contacto con nosotros para obtener una lectura guiada.<\/p> <\/div> <\/div>\n","protected":false},"excerpt":{"rendered":"<p>MDx CRO present\u00f3 nuevas pruebas y aprendizajes pr\u00e1cticos en ESMO 2025 que refuerzan nuestra posici\u00f3n como el socio preferido para las transiciones IVDR y los ensayos cl\u00ednicos combinados que involucran IVD en investigaci\u00f3n. Fuimos primer autor en un p\u00f3ster con Fulgent Genetics y colaboradores en un p\u00f3ster de Servier, ambos centrados en las realidades operativas [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":8659,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[215],"tags":[219,334,377,218,266,220,379,378],"resources-sector":[178,182,179],"class_list":["post-8619","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-eventos-y-congresos","tag-cdx-es","tag-ensayos-clinicos","tag-esmo2025-es","tag-ivdr-es","tag-mdx-cro-es","tag-ngs-es","tag-poster-es","tag-resumenes","resources-sector-ivds","resources-sector-laboratories","resources-sector-precision-medicine-cdx"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MDx CRO en ESMO 2025: IVDR y ensayos combinados<\/title>\n<meta name=\"description\" content=\"MDx CRO comparti\u00f3 informaci\u00f3n de primera mano sobre IVDR y lecciones de ensayos combinados CHONQUER en ESMO 2025: evidencia para promotores que navegan por IVDR y CTR.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mdxcro.com\/es\/mdx-cro-en-esmo-2025-berlin-avanzando-en-las-transiciones-de-ivdr-y-los-ensayos-clinicos-combinados\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDx CRO en ESMO 2025: IVDR y ensayos combinados\" \/>\n<meta property=\"og:description\" content=\"MDx CRO comparti\u00f3 informaci\u00f3n de primera mano sobre IVDR y lecciones de ensayos combinados CHONQUER en ESMO 2025: evidencia para promotores que navegan por IVDR y CTR.\" \/>\n<meta property=\"og:url\" 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