{"id":12751,"date":"2025-07-30T07:24:22","date_gmt":"2025-07-30T07:24:22","guid":{"rendered":"https:\/\/mdxcro.com\/services\/medicina-di-precisione-diagnostica-di-accompagnamento\/"},"modified":"2026-08-06T16:26:56","modified_gmt":"2026-08-06T16:26:56","slug":"medicina-di-precisione-diagnostica-di-accompagnamento","status":"publish","type":"service","link":"https:\/\/mdxcro.com\/it\/servizi\/medicina-di-precisione-diagnostica-di-accompagnamento\/","title":{"rendered":"Medicina di Precisione e CDx"},"content":{"rendered":"\n<section id=\"block_bde494f6c2dd4ce171f5da59aa4da236\" class=\"hero hero--with-form\" style=\"padding-top: var(--wp--preset--spacing--medium); padding-bottom: var(--wp--preset--spacing--medium);\">\n    <div class=\"hero--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/04\/Services-MDx-CRO.webp\" fetchpriority=\"high\" class=\"no-lazy\" alt=\"\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"hero__grid\">\n            <div class=\"hero__content-col\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">Il partner di precisione per la diagnostica di accompagnamento e gli studi clinici basati sui biomarcatori<\/h1>\n            \n                            <div class=\"description\"><p><span style=\"font-weight: 400;\">MDx CRO \u00e8 una CRO specializzata in medicina di precisione e diagnostica di accompagnamento, che supporta i team IVD e farmaceutici nella progettazione e conduzione di studi clinici per lo sviluppo di companion diagnostics (CDx).<br \/>Gestiamo l\u2019intero percorso di sviluppo dei CDx, dalla validazione dei biomarcatori alla conformit\u00e0 al regolamento IVDR, incluse le Q-Submission alla FDA e l\u2019esecuzione clinica conforme alla norma ISO 20916. <\/span><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a 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Allineiamo la strategia di sviluppo dei biomarcatori e la validazione dei test diagnostici ai requisiti dell\u2019Allegato XIV dell\u2019IVDR e ai percorsi regolatori della FDA, incluse le procedure PMA e Q-Submission, per accelerare l\u2019accesso al mercato nell\u2019Unione europea, nel Regno Unito e negli Stati Uniti. <\/p>\n<p data-start=\"1804\" data-end=\"2126\">Dalla selezione del percorso SRD vs NSRD e preparazione Q-sub alla progettazione e monitoraggio dello studio ISO 20916, il nostro team offre <strong>esecuzione CRO CDx end-to-end<\/strong>\u2014inclusi servizi di delega dello sponsor e rappresentante legale UE\/UK.<\/p>\n<\/div><a class=\"button\" href=\"https:\/\/mdxcro.com\/it\/contatti\/\" target=\"_self\">Scopri come pianificare uno studio di performance sotto IVDR Allegato XIV<\/a><\/div><\/div>                            <div class=\"column column--image\"><div class=\"video-player video-player--youtube\" data-youtube-url=\"https:\/\/www.youtube.com\/embed\/E8RbCzAtJtY\"><div class=\"youtube-container\"><div class=\"youtube-poster\"><img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDx-CRO-CDx-services.jpg\" alt=\"IVDR Annex XIV submission support for companion diagnostics\" \/><button class=\"play-btn youtube-play-btn\"><\/button><\/div><div class=\"youtube-iframe-container\" style=\"display: none\"><!-- Iframe will be created here dynamically --><\/div><\/div><\/div><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_73bebca75b513224cfb7b98dd62de23e\" class=\"flip-cards flip-cards--three-columns flip-cards--grayscale \" style=\"\">\n            <div class=\"container\">\n        <div class=\"content\">\n                            <h3 class=\"subtitle\">Il Tuo Percorso di test diagnostico di accompagnamento<br \/>Completamente Gestito, Passo dopo Passo<\/h3>\n            \n                            <h2 class=\"title\">UN OBIETTIVO<\/h2>\n            \n                            <div class=\"teaser wysiwyg\"><p>Approvazioni regolatorie senza ritardi. Primo paziente, primo campione \u2014 pi\u00f9 velocemente.<\/p>\n<\/div>\n            \n                            <div class=\"description wysiwyg\"><p>Guidiamo gli sponsor di medicina di precisione attraverso ogni fase critica, allineando flussi di lavoro clinici, regolatori e operativi per accelerare il tuo percorso verso l&#8217;approvazione.<\/p>\n<\/div>\n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--background-blue card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">01<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Strategia Clinica CDx e Roadmapping Regolatorio (FDA + IVDR)<\/div>\n                        <div class=\"back\"><p>Definisci il tuo percorso di sviluppo con la guida esperta sui requisiti FDA e IVDR \u2014 incluse determinazioni <strong>SRD vs NSRD<\/strong>, meeting Q-sub e submission PMA. La nostra intelligence regolatoria copre USA ed UE. <\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image card--value\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/biomarker-assay-validation.jpg&#039;);\"                         >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">02<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Validazione Biomarcatori e Saggi<\/div>\n                        <div class=\"back\"><p>Supporto per scoperta di biomarcatori, sviluppo di saggi per trial clinici, validazione analitica e strategia di biomarcatori traslazionali. Include validazione di saggi per piattaforme qPCR, NGS, IHC e SaMD. <\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">03<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Due Diligence di Laboratori e Partner Diagnostici<\/div>\n                        <div class=\"back\"><p>Qualifichiamo fornitori di laboratori, LDT e siti di test secondo ISO 15189 e requisiti marchio CE, conducendo due diligence per idoneit\u00e0 del test e conformit\u00e0 IVDR per <strong data-start=\"3134\" data-end=\"3159\">saggi di trial clinici<\/strong> destinati a claim <strong data-start=\"3173\" data-end=\"3180\">CDx<\/strong>.<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image card--value\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/design-sponsor.jpg&#039;);\"                         >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">04<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Progettazione Studio Clinico e Delega dello Sponsor<\/div>\n                        <div class=\"back\"><p>Dal CPSP e definizione degli endpoint alla gestione del rischio e consenso informato, progettiamo e conduciamo <a href=\"https:\/\/mdxcro.com\/it\/servizi\/studi-clinici-sullivd\/\"><strong>trial clinici conformi a ISO 20916<\/strong><\/a>. MDx pu\u00f2 agire come tuo <a href=\"https:\/\/mdxcro.com\/it\/servizi\/servizi-di-rappresentanza\/\">rappresentante legale UE\/UK<\/a>. <\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">05<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Gestione e Monitoraggio Siti di Test (ISO 20916)<\/div>\n                        <div class=\"back\"><p>Operazioni cliniche end-to-end \u2014 qualificazione siti, formazione, monitoraggio e preparazione agli audit \u2014 garantendo aderenza al protocollo e allineamento GCP con monitoraggio on-site e remoto <strong data-start=\"3469\" data-end=\"3482\">ISO 20916<\/strong>.<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image card--value\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/data-collection.jpg&#039;);\"                         >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">06<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Raccolta Dati, Biostatistica e Report Conformi IVDR<\/div>\n                        <div class=\"back\"><p>Gestiamo progettazione eCRF, analisi statistica e sviluppo di report di studi delle prestazioni clinica per submission IVDR, inclusi <strong data-start=\"3620\" data-end=\"3658\">report di studi delle prestazioni clinica<\/strong> per <strong data-start=\"3663\" data-end=\"3681\">IVDR Allegato XIV.<\/strong><\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">07<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Submission Regolatorie (UE e USA)<\/div>\n                        <div class=\"back\"><p>Da <a href=\"https:\/\/mdxcro.com\/it\/servizi\/affari-regolamentari-documentazione-tecnica\/\"><strong>pacchetti FDA PMA e Q-submission<\/strong><\/a> ad applicazioni IVDR Allegato XIV, gestiamo tutte le comunicazioni con comitati etici e autorit\u00e0 competenti, RFI e modifiche.<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image card--value\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/safety-evaluation-reporting.jpg&#039;);\"                         >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">08<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Valutazione e Reporting della Sicurezza<\/div>\n                        <div class=\"back\"><p>Classificazione e risposta agli eventi avversi, incluse comunicazioni con Organismi Notificati e Comitati Etici. Copre reporting di sicurezza IVDR nei trial clinici. <\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image card--image-only\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/logo-for-cards.jpg&#039;);\"                         >\n                        \n                                                                            \n                        <div class=\"front\"><\/div>\n                        <div class=\"back\"><\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section><section class=\"table\"><div class=\"container\"><div class=\"headline\">Cosa distingue la nostra CRO CDx per sponsor di medicina di precisione<\/div><div class=\"table-wrapper\"><div class=\"feature-column-wrapper\"><table class=\"feature-table\"><thead><tr><th class=\"feature-column\">Caratteristica o Capacit\u00e0<\/th><\/tr><\/thead><tbody><tr><td class=\"feature-cell\">Supporto Submission IVDR Allegato XIV (CDx)<\/td><\/tr><tr><td class=\"feature-cell\">Consulenza CDx (FDA + UE)<\/td><\/tr><tr><td class=\"feature-cell\">Monitoraggio ISO 20916 (CDx)<\/td><\/tr><tr><td class=\"feature-cell\">Delega dello Sponsor e Rappresentante Legale UE\/UK<\/td><\/tr><tr><td class=\"feature-cell\">Sviluppo Documentazione IVD<\/td><\/tr><tr><td class=\"feature-cell\">Competenza Traslazionale e Biomarcatori<\/td><\/tr><tr><td class=\"feature-cell\">Regulatory Intelligence<\/td><\/tr><\/tbody><\/table><\/div><div class=\"scrollable-columns-wrapper\"><table class=\"comparison-table\"><thead><tr><th class=\"column highlight\">MDx CRO<\/th><th class=\"column\">Altre CRO<\/th><th class=\"column\">Team Interni<\/th><\/tr><\/thead><tbody><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Track record comprovato<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Limitato o esternalizzato<\/td><td class=\"cell\"><img decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Raramente con esperienza<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Specializzati in CDx<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Generalisti<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Richiede molte risorse<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Esperti di laboratorio interni<\/td><td class=\"cell\"><img decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Mancano competenze di laboratorio<\/td><td class=\"cell\"><img decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Non consentito<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Copertura completa UE\/UK<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Parziale o solo locale<\/td><td class=\"cell\"><img decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Non consentito<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Sviluppato internamente<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Esternalizzato<\/td><td class=\"cell\"><img decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Lacune nelle competenze<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Oncologia, malattie rare, NGS<\/td><td class=\"cell\"><img decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Profondit\u00e0 limitata<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Non sempre specializzati<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Database centrale UE\/CE<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Visibilit\u00e0 parziale<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Capacit\u00e0 limitata<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n<section id=\"block_9643fb15bf25ae6299085de5517b89d2\" class=\"content-columns content-columns--three-columns \" style=\"\">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">Aree Terapeutiche e Tecnologie<\/h2>\n                                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Focus Terapeutico<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Oncologia<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">NSCLC, HPV, Cancro al Seno, PIWIL1+, tumori MTAP-deleted, CRC<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Disturbi Retinici ed Ereditari<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Terapia Genica e Cellulare<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Sindromi Mielodisplastiche<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Tecnologie e Piattaforme<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">PCR (KRAS, EGFR, ESR1, BRAF)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Pannelli NGS, Biopsia Liquida<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Immunoassay (es. AAV8)<\/span><\/li>\n<li style=\"font-weight: 400\">Saggi di test diagnostici di accompagnamento (CDx) (NGS, qPCR, IHC)<\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">SaMD \/ Diagnostica Digitale<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Sequenziamento HLA<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Applicazioni Biomarcatori<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Biomarcatori Predittivi e Prognostici<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Saggi Diagnostici<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Software CDx<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Sviluppo Saggi Traslazionali<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n\n<section id=\"block_b658dbadd3ae8a3810ea5b2ecb4a473f\" class=\"testimonials\" style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/testimonials-bg.jpg&#039;);\">\n        <div class=\"testimonials--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/testimonials-bg.jpg\" alt=\"\" \/>\n    <\/div>\n    <div class=\"container\">\n                    <div class=\"headline\">Cosa Dicono i Nostri Clienti<\/div>\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">&#8220;Delegating device sponsor responsibilities to MDx significantly improved our clinical trial operations. Their team filled critical knowledge gaps on ISO 20916, streamlined ethics submissions, and helped us secure approvals in multiple EU countries.&#8221;<\/p>\n                                                                            <p class=\"author\">\n                                \u2014 Senior Director, Clinical Projects, Global Pharma                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">&#8220;MDx\u2019s clinical and regulatory knowledge filled critical gaps. Their team worked tirelessly to help us reach IVD study approvals across Europe.&#8221;<\/p>\n                                                                            <p class=\"author\">\n                                Senior Director, Clinical Projects                                                                <br>\n                                Global Pharma                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">&#8220;Truly the EU extension of our team. Their responsiveness and attention to detail drove our CDx transition success.&#8221;<\/p>\n                                                                            <p class=\"author\">\n                                Regulatory Director                                                                <br>\n                                US-Based Precision Medicine Company                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">&#8220;We relied on MDx to lead our Annex XIV application and clinical performance study. Their integrated approach across regulatory, clinical, and lab operations accelerated our EU timeline and avoided costly validation rework. They are more than a CRO \u2014 they\u2019re a strategic CDx partner.&#8221;<\/p>\n                                                                            <p class=\"author\">\n                                VP, Diagnostic Strategy                                                                <br>\n                                European Oncology Biotech                                        \n                            <\/p>\n                                            <\/div>\n                            <\/div>\n        \n        <div class=\"footer\">\n            <div class=\"slider-dots\"><\/div>\n            <div class=\"button-wrapper\">\n                            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n\n\n<section id=\"block_ff3a5824fe2da6a354e755e6aa1ba3e3\" class=\"text-image\" style=\"padding-top: var(--wp--preset--spacing--xxlarge); \">\n    \t<div \n\t\tclass=\"component-top-icon\"\n\t\tstyle=\"--component-top-icon-height: 60px\"\n\t>\n\t\t<img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-icon.svg\" alt=\"\" \/>\n\t<\/div>\n\t    <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Chi Serviamo<\/h2><div class=\"description wysiwyg\"><ul>\n<li>Aziende pharma globali che co-sviluppano test diagnostici di accompagnamento (CDx)<\/li>\n<li>Produttori IVD e CDx<\/li>\n<li>Sviluppatori di diagnostica focalizzati sull&#8217;oncologia<\/li>\n<li>Sponsor con sede negli USA che conducono studi clinici di test diagnostici di accompagnamento (CDx) in Europa<\/li>\n<li><a href=\"https:\/\/mdxcro.com\/it\/servizi\/software-salute-digitale-intelligenza-artificiale\/\">Piattaforme diagnostiche digitali e software<\/a><\/li>\n<\/ul>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/68778a52ad1ece5602fe45605fa28d420d1bd9a1.jpg\" alt=\"Advanced medical researchers conducting laboratory experiments to accelerate medical technology development for healthcare innovation.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section class=\"key-stats\"  style=\"\">\n    <div class=\"container\">\n          <div class=\"headline\">Il Nostro Track Record in Numeri<\/div>\n    \n    <div class=\"main-wrapper\">\n              <div class=\"box-grid\">\n                                    <div class=\"box\">\n                                  <div class=\"value\">30+<\/div>\n                                                  <div class=\"legend\">Studi Combinati<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">400+<\/div>\n                                                  <div class=\"legend\">Documenti Essenziali Sviluppati<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">Fasi I-III<\/div>\n                                                  <div class=\"legend\">Trial Clinici<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">UE27\/UK<\/div>\n                                                  <div class=\"legend\">submission<\/div>\n                              <\/div>\n                              <\/div>\n      \n              <img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/world-map-left-text.jpg\" alt=\"Advanced CDx innovation driving healthcare solutions across Europe.\" \/>\n          <\/div>\n\n    <div class=\"data\">\n              <div class=\"description wysiwyg\">\n          <p><b>Programmi CDx Commerciali Realizzati<\/b><\/p>\n<p><span style=\"font-weight: 400\">MDx ha supportato con successo l&#8217;esecuzione di studi delle prestazioni e submission regolatorie per programmi CDx commercializzati in tutto il mondo.<\/span><\/p>\n<p>Supportiamo la test diagnostici di accompagnamento (CDx) dalla validazione clinica attraverso FDA PMA\/Q-submission e applicazioni IVDR Allegato XIV, allineando le tempistiche CDx con lo sviluppo del farmaco, incluse <a href=\"https:\/\/mdxcro.com\/companion-diagnostics-consultancy-in-the-eu-a-comprehensive-guide\/\"><b>consultazioni EMA e Organismi Notificati.<\/b><\/a><\/p>\n        <\/div>\n      \n              <div class=\"description wysiwyg\">\n          <p><span style=\"font-weight: 400\">Il nostro track record include:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>Saggi IHC HER2<\/b><span style=\"font-weight: 400\"> per cancro al seno e gastrico<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Kit di rilevamento mutazioni EGFR<\/b><span style=\"font-weight: 400\"> per NSCLC<\/span><\/li>\n<li style=\"font-weight: 400\"><a href=\"https:\/\/mdxcro.com\/it\/servizi\/ngs-servizi\/\"><b>Pannelli NGS<\/b><\/a><span style=\"font-weight: 400\"><strong> con claim CDx<\/strong> (CRC e tumori solidi)<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Saggi qPCR e multiplex<\/b><span style=\"font-weight: 400\"> validati secondo IVDR e FDA<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n        <\/div>\n          <\/div>\n  <\/div>\n<\/section>\n<section id=\"block_68a3eed73ecee0473b0b970c19f106f7\" class=\"faqs\" style=\"\">\n    <div class=\"container\">\n    <div class=\"content\">\n      <div class=\"column\">\n                  <h2 class=\"headline\">Domande frequenti<\/h2>\n                          <a class=\"button button--quaternary\" href=\"https:\/\/mdxcro.com\/it\/contatti\/\" target=\"\">\n            Facci una Domanda          <\/a>\n              <\/div>\n      <div class=\"column\">\n                  <ul class=\"faq-list\">\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Cos&#039;\u00e8 la decisione SRD vs NSRD per CDx negli USA?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>La FDA distingue studi <strong data-start=\"6266\" data-end=\"6299\">Significant Risk Device (SRD)<\/strong> da <strong data-start=\"6305\" data-end=\"6343\">Non-Significant Risk Device (NSRD)<\/strong>. Guidiamo gli sponsor CDx attraverso interazioni <strong data-start=\"6383\" data-end=\"6392\">Q-sub<\/strong> e determiniamo il percorso giusto verso <strong data-start=\"6442\" data-end=\"6449\">PMA<\/strong> o altre submission. <\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Cos&#039;\u00e8 l&#039;IVDR Allegato XIV per la test diagnostici di accompagnamento (CDx)?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>L&#8217;Allegato XIV definisce i requisiti per gli <strong data-start=\"5956\" data-end=\"5986\">studi delle prestazioni clinica<\/strong> per IVD, inclusi <strong data-start=\"6020\" data-end=\"6027\">CDx<\/strong>, nell&#8217;UE. Copre submission, processi etici\/autorit\u00e0 competenti ed aspettative di evidenza per la valutazione di conformit\u00e0 <strong data-start=\"6131\" data-end=\"6139\">IVDR<\/strong>. <\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">MDx pu\u00f2 agire come rappresentante legale per CDx e studi delle prestazioni IVDR nell&#039;UE?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">S\u00ec. Offriamo servizi di sponsor delegato, submission a comitati etici\/autorit\u00e0 competenti e <a href=\"https:\/\/mdxcro.com\/it\/servizi\/servizi-di-rappresentanza\/\">rappresentanza legale<\/a> \u2014 gestendo documentazione e comunicazioni per tuo conto.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Supportate sia IVDR che FDA PMA o Q-submission per CDx?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Assolutamente. Definiamo strategie di submission, coordiniamo la generazione di evidenze e gestiamo comunicazioni end-to-end con Organismi Notificati UE, EMA e FDA, incluse <strong data-start=\"6568\" data-end=\"6593\">FDA PMA\/Q-submission<\/strong> e applicazioni <strong data-start=\"6598\" data-end=\"6616\">IVDR Allegato XIV<\/strong>. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Quali sfide esistono quando si conducono studi combinati sotto CTR e IVDR?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Gli studi combinati affrontano disallineamento regolatorio \u2014 IVDR e CTR hanno requisiti, tempistiche e percorsi di submission diversi. MDx aiuta gli sponsor a navigare queste complessit\u00e0 sviluppando strategie integrate, garantendo che i dati clinici e di performance soddisfino le aspettative distinte dei regolatori di dispositivi medici e prodotti medicinali. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                      <\/ul>\n              <\/div>\n    <\/div>\n  <\/div>\n<\/section>\n\n  <script type=\"application\/ld+json\">\n    {\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Cos'\u00e8 la decisione SRD vs NSRD per CDx negli USA?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"La FDA distingue studi Significant Risk Device (SRD) da Non-Significant Risk Device (NSRD). Guidiamo gli sponsor CDx attraverso interazioni Q-sub e determiniamo il percorso giusto verso PMA o altre submission.\"}},{\"@type\":\"Question\",\"name\":\"Cos'\u00e8 l'IVDR Allegato XIV per la test diagnostici di accompagnamento (CDx)?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"L&#8217;Allegato XIV definisce i requisiti per gli studi delle prestazioni clinica per IVD, inclusi CDx, nell&#8217;UE. Copre submission, processi etici\/autorit\u00e0 competenti ed aspettative di evidenza per la valutazione di conformit\u00e0 IVDR.\"}},{\"@type\":\"Question\",\"name\":\"MDx pu\u00f2 agire come rappresentante legale per CDx e studi delle prestazioni IVDR nell'UE?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"S\u00ec. Offriamo servizi di sponsor delegato, submission a comitati etici\/autorit\u00e0 competenti e rappresentanza legale \u2014 gestendo documentazione e comunicazioni per tuo conto.\"}},{\"@type\":\"Question\",\"name\":\"Supportate sia IVDR che FDA PMA o Q-submission per CDx?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Assolutamente. Definiamo strategie di submission, coordiniamo la generazione di evidenze e gestiamo comunicazioni end-to-end con Organismi Notificati UE, EMA e FDA, incluse FDA PMA\/Q-submission e applicazioni IVDR Allegato XIV.\"}},{\"@type\":\"Question\",\"name\":\"Quali sfide esistono quando si conducono studi combinati sotto CTR e IVDR?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Gli studi combinati affrontano disallineamento regolatorio \u2014 IVDR e CTR hanno requisiti, tempistiche e percorsi di submission diversi. MDx aiuta gli sponsor a navigare queste complessit\u00e0 sviluppando strategie integrate, garantendo che i dati clinici e di performance soddisfino le aspettative distinte dei regolatori di dispositivi medici e prodotti medicinali.\"}}]}  <\/script>\n\n<section id=\"block_4c70669953db697c9448e5969452711b\" class=\"call-to-action\" style=\"\">\n        <div class=\"call-to-action--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/mdx-cta-bg.png\" alt=\"\" \/>\n    <\/div>\n    <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"content\">\n                                    <h2 class=\"title\">Acceleriamo il Tuo CDx verso il Mercato<\/h2>\n                \n                                    <div class=\"description wysiwyg\">\n                        <p>Che tu stia co-sviluppando un CDx con un partner pharma o preparando la tua prima submission IVDR Allegato XIV, MDx \u00e8 la tua CRO full-service per test diagnostici di accompagnamento (CDx) per successo regolatorio e approvazione globale, offrendo studi ISO 20916, rappresentante legale UE\/UK e supporto FDA PMA\/Q-sub.<\/p>\n<p><b>Il Tuo CDx. La Nostra Competenza. Impatto Globale.  <\/b><\/p>\n                    <\/div>\n                            <\/div>\n\n                            <div class=\"button-wrapper\">\n                                                                        <a href=\"https:\/\/mdxcro.com\/it\/contatti\/?utm_source=prec_med_cdx\" class=\"button button--tertiary\" target=\"\">\n                                Prenota una Consulenza CDx                            <\/a>\n                                                            <\/div>\n                    <\/div>\n    <\/div>\n<\/section>\n\n<script type=\"application\/ld+json\">{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"Service\",\n  \"serviceType\": \"Companion Diagnostics (CDx) and Precision Medicine Services\",\n  \"provider\": {\n    \"@type\": \"Organization\",\n    \"name\": \"MDx CRO\",\n    \"url\": \"https:\/\/www.mdxcro.com\",\n    \"logo\": \"https:\/\/www.mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX.svg\"\n  },\n  \"areaServed\": [\n    {\n      \"@type\": \"Place\",\n      \"name\": \"European Union\"\n    },\n    {\n      \"@type\": \"Place\", \n      \"name\": \"United States\"\n    },\n    {\n      \"@type\": \"Place\",\n      \"name\": \"Asia\"\n    }\n  ],\n  \"description\": \"End-to-end companion diagnostics development services including clinical validation, FDA and IVDR regulatory strategy, and co-development support for pharmaceutical and diagnostic partners.\",\n  \"hasOfferCatalog\": {\n    \"@type\": \"OfferCatalog\",\n    \"name\": \"Companion Diagnostics Services\",\n    \"itemListElement\": [\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"CDx Clinical Validation Studies\"\n        }\n      },\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"FDA CDx Regulatory Strategy\"\n        }\n      },\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"Pharma-Diagnostic Co-Development\"\n        }\n      },\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"Biomarker Validation Studies\"\n        }\n      }\n    ]\n  }\n}\n<\/script>\n","protected":false},"featured_media":0,"parent":0,"menu_order":0,"template":"","meta":{"_acf_changed":false},"class_list":["post-12751","service","type-service","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CRO per Diagnostica Companion | Servizi IVDR e FDA CDx | MDx CRO<\/title>\n<meta name=\"description\" content=\"CRO per diagnostica companion per programmi IVDR Allegato XIV, ISO 20916 e FDA PMA CDx. 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