{"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":"2026-01-22T10:38:28","modified_gmt":"2026-01-22T10:38:28","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>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<h2 class=\"wp-block-heading\">Aspectos destacados de nuestros p\u00f3steres de ESMO 2025<\/h2>\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-cb16bb21d34c832d4aeca29c159abe05\">Fulgent genetics &amp; MDx CRO \u2014 <em>MDx CRO primer autor<\/em><\/h4>\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<p><strong>Lo que cubre:<\/strong><\/p>\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<p><strong>Por qu\u00e9 es importante:<\/strong> Los patrocinadores 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<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 loading=\"lazy\" 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&#xED;n presentando un p&#xF3;ster sobre el cumplimiento del IVDR para paneles grandes de NGS para pruebas de enfermedades de la l&#xED;nea 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=\"auto, (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 &#8211; Presentaci\u00f3n de p\u00f3ster en ESMO 2025 en Berl\u00edn<\/strong><\/figcaption><\/figure>\n<\/figure>\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-85a856468490a3cb27b5bb71982a9324\">Servier &amp; MDx CRO (estudio CHONQUER) \u2014 <em>Colaborador de MDx CRO<\/em><\/h4>\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<p><strong>Lo que cubre:<\/strong><\/p>\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<p><strong>Por qu\u00e9 es importante:<\/strong> Los patrocinadores 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<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 loading=\"lazy\" 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&#xF3; un p&#xF3;ster en ESMO 2025 (Berl&#xED;n) sobre estudios cl&#xED;nicos 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=\"auto, (max-width: 1600px) 100vw, 1600px\" \/><figcaption class=\"wp-element-caption\"><strong>Dra. Marketa Svobodova, directora de Medicina de Precisi\u00f3n de MDx &#8211; Presentaci\u00f3n de p\u00f3ster en ESMO 2025 &#8211; Estudio CHONQUER, un estudio combinado bajo IVDR\/CTR<\/strong><\/figcaption><\/figure>\n<\/figure>\n\n<h2 class=\"wp-block-heading\">Conclusiones clave para los patrocinadores<\/h2>\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<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"has-regular-font-size\">\u00bfNecesita una sesi\u00f3n informativa r\u00e1pida? <a href=\"\/es\/?page_id=8492\">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<h2 class=\"wp-block-heading\">Preguntas frecuentes<\/h2>\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 v27.4 - 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 patrocinadores 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 patrocinadores que navegan por IVDR y CTR.\" \/>\n<meta property=\"og:url\" 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