{"id":12719,"date":"2025-07-30T07:26:59","date_gmt":"2025-07-30T07:26:59","guid":{"rendered":"https:\/\/mdxcro.com\/services\/studi-analitici-sullivd\/"},"modified":"2026-08-17T13:15:10","modified_gmt":"2026-08-17T13:15:10","slug":"studi-analitici-ivd","status":"publish","type":"service","link":"https:\/\/mdxcro.com\/it\/servizi\/studi-analitici-ivd\/","title":{"rendered":"Studi analitici IVD"},"content":{"rendered":"\n<section id=\"block_0e5372c54544ee9ae0b4e20582d76be7\" class=\"hero\">\n    <div class=\"hero--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/04\/sectors-MDx-CRO.webp\" fetchpriority=\"high\" class=\"no-lazy\" alt=\"\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">Validazione analitica IVD che accelera l&#8217;approvazione globale<\/h1>\n            \n                            <div class=\"description\"><p><span style=\"font-weight: 400;\">Studi sulle prestazioni analitiche guidati da esperti per la conformit\u00e0 IVDR, FDA e CLSI, che coprono sensibilit\u00e0, specificit\u00e0, stabilit\u00e0 e APR. Accedi pi\u00f9 velocemente al mercato con MDx CRO. <\/span><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"https:\/\/mdxcro.com\/it\/contatti\/?utm_source=ivd_analytical_studies\" class=\"button button--default\" target=\"_self\">\n                            Prenota una consulenza                        <\/a>\n                                            <a href=\"https:\/\/mdxcro.com\/a-cros-guide-to-ivd-analytical-validation-best-practices-common-pitfalls\/\" class=\"button button--secondary\" target=\"_self\">\n                            Esplora la nostra guida alla validazione analitica IVD                        <\/a>\n                                    <\/div>\n                            <\/div>\n            <\/div>\n<\/section>\n\n<section id=\"block_20eb9c1f617b6c3ea7f22c7b2d1b84a2\" class=\"text-image\" style=\"margin-top: var(--wp--preset--spacing--regular); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Perch\u00e9 la <span class=\"blue-highlight\"> validazione analitica <\/span> \u00e8 importante<\/h2><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\">La validazione analitica \u00e8 il fondamento per le evidenze cliniche IVD e l&#8217;approvazione normativa. Sia che tu stia lanciando un nuovo test diagnostico o stia portando un prodotto legacy verso l&#8217;IVDR, dati solidi sulle prestazioni analitiche sono essenziali per dimostrare l&#8217;affidabilit\u00e0, l&#8217;accuratezza e la sicurezza del test. In MDx CRO, forniamo studi analitici che soddisfano i pi\u00f9 elevati standard globali, garantendo che le tue dichiarazioni sulle prestazioni siano supportate, che le sottomissioni abbiano successo e che le tempistiche siano rispettate.  <\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>Ambito completo:<\/b><span style=\"font-weight: 400\"> studi di sensibilit\u00e0 analitica, specificit\u00e0, accuratezza, precisione, LoD\/LoQ, linearit\u00e0 e stabilit\u00e0.<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Allineamento normativo:<\/b><span style=\"font-weight: 400\"> linee guida IVDR Allegato I, FDA 510(k)\/PMA e CLSI (EP05, EP17, EP25, ecc.).<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Partner di laboratorio qualificati ISO 15189<\/b><span style=\"font-weight: 400\"> e una comprovata esperienza con gli Organismi Notificati e la FDA.<\/span><\/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\/07\/analytical-validation.jpg\" alt=\"Innovative scientist working in a modern laboratory focused on advancing medtech solutions for healthcare.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_0d519186db586910d2e2550bb37e6611\" class=\"flip-cards flip-cards--three-columns \" style=\"padding-bottom: var(--wp--preset--spacing--regular); \">\n            <div class=\"container\">\n        <div class=\"content\">\n                            <h3 class=\"subtitle\">Progettazione ed esecuzione completa di studi analitici<\/h3>\n            \n                            <h2 class=\"title\">MDx CRO offre una validazione analitica end-to-end per gli IVD<\/h2>\n            \n            \n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--background-white\"\n                                                  >\n                        \n                                                    <div class=\"circle circle--no-bg\">\n                                <img decoding=\"async\" class=\"icon\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-Black-61.png\" alt=\"\" \/>\n                                <img decoding=\"async\" class=\"icon icon--hover\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-61.png\" alt=\"\" \/>\n                            <\/div>\n                        \n                        <div class=\"front\">Pianificazione e Strategia<\/div>\n                        <div class=\"back\"><ul>\n<li>Roadmap normativa (IVDR\/FDA)<\/li>\n<li>Piano delle prestazioni analitiche<\/li>\n<li>Sviluppo del protocollo<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                    <div class=\"circle circle--no-bg\">\n                                <img decoding=\"async\" class=\"icon\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-2.png\" alt=\"\" \/>\n                                <img decoding=\"async\" class=\"icon icon--hover\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-2.png\" alt=\"\" \/>\n                            <\/div>\n                        \n                        <div class=\"front\">Validazione del test<\/div>\n                        <div class=\"back\"><ul>\n<li>Validazione del metodo analitico<\/li>\n<li>Progettazione dello studio conforme al CLSI<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black\"\n                                                  >\n                        \n                                                    <div class=\"circle circle--no-bg\">\n                                <img decoding=\"async\" class=\"icon\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-6.png\" alt=\"\" \/>\n                                <img decoding=\"async\" class=\"icon icon--hover\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-Black-6-1.png\" alt=\"\" \/>\n                            <\/div>\n                        \n                        <div class=\"front\">Esecuzione Studio<\/div>\n                        <div class=\"back\"><ul>\n<li>Qualificazione del sito e del laboratorio, gestione del progetto<\/li>\n<li>Monitoraggio,<\/li>\n<li>Raccolta dati<\/li>\n<li>Prontezza per gli audit<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                    <div class=\"circle circle--no-bg\">\n                                <img decoding=\"async\" class=\"icon\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-46.png\" alt=\"\" \/>\n                                <img decoding=\"async\" class=\"icon icon--hover\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-46.png\" alt=\"\" \/>\n                            <\/div>\n                        \n                        <div class=\"front\">Reporting e sottomissione<\/div>\n                        <div class=\"back\"><ul>\n<li>Rapporto sulle prestazioni analitiche (APR)<\/li>\n<li>Pacchetti di evidenze IVDR<\/li>\n<li>Supporto per la Q-submission FDA<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white\"\n                                                  >\n                        \n                                                    <div class=\"circle circle--no-bg\">\n                                <img decoding=\"async\" class=\"icon\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-Black-4-1.png\" alt=\"\" \/>\n                                <img decoding=\"async\" class=\"icon icon--hover\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-4.png\" alt=\"\" \/>\n                            <\/div>\n                        \n                        <div class=\"front\">Tecnologie supportate<\/div>\n                        <div class=\"back\"><ul>\n<li>PCR<\/li>\n<li>NGS<\/li>\n<li>IHC, saggi immunologici<\/li>\n<li>Multiplex<\/li>\n<li>Flusso laterale<\/li>\n<li>SaMD<\/li>\n<li>e altro ancora<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Formazione e trasferimento di conoscenze<\/div>\n                        <div class=\"back\"><ul>\n<li>  Processi di validazione analitica<\/li>\n<li>Requisiti delle evidenze IVDR<\/li>\n<li>Trasferimento di conoscenze per capacit\u00e0 interne sostenibili<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section>\n<section id=\"block_3590fa5c83c96d148c6e034b358d4cc9\" class=\"content-columns content-columns--four-columns content-columns--background-white\" style=\"padding-top: var(--wp--preset--spacing--regular); padding-bottom: var(--wp--preset--spacing--regular); \">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">Cosa offriamo<\/h2>\n                                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Protocolli di validazione del test<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Sensibilit\u00e0 e specificit\u00e0 analitica<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Studi di accuratezza e precisione<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Limite di rilevabilit\u00e0 (LoD) \/ limite di quantificazione (LoQ) \/ linearit\u00e0<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Interferenza e reattivit\u00e0 crociata<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Riproducibilit\u00e0 e ripetibilit\u00e0<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Supporto per la pre-qualificazione OMS<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Progettazione dello studio di stabilit\u00e0<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Studi di stabilit\u00e0 in tempo reale e accelerati<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Sviluppo del protocollo (CLSI EP25)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Analisi dei dati e reporting<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Documentazione e rapporti<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Protocolli di validazione analitica<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Rapporti sulle prestazioni analitiche (APR)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Pacchetti di evidenze conformi all&#8217;IVDR<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Documentazione per la Q-submission FDA<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Tipi di test supportati<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Diagnostica molecolare (PCR, qPCR, NGS)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Saggi immunologici e piattaforme multiplex<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Kit diagnostici basati su IHC<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Diagnostica basata su software (SaMD)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Test a flusso laterale e point-of-care<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n                    <div class=\"button-wrapper\">\n                                    <a href=\"https:\/\/mdxcro.com\/it\/aree-terapeutiche\/\" class=\"button button--quaternary\" target=\"_self\">\n                        Esplora tutte le aree terapeutiche                    <\/a>\n                            <\/div>\n            <\/div>\n<\/section>\n\n<section id=\"block_7d8e34599958a62e736ffc39ea2a2ecf\" class=\"text-image text-image--background-frost-white text-image--reduced-spacing\" style=\"padding-top: var(--wp--preset--spacing--medium); padding-bottom: var(--wp--preset--spacing--medium); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Allineamento Regolatorio<\/h2><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\">I tuoi studi analitici sono mappati su tutti i principali requisiti internazionali:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>IVDR Allegato I, Capitolo II, Parte A<\/b><span style=\"font-weight: 400\"> \u2013 Requisiti delle prestazioni analitiche<\/span><\/li>\n<li style=\"font-weight: 400\"><b>FDA 510(k), De Novo, PMA<\/b><span style=\"font-weight: 400\"> \u2013 Validazione analitica e generazione di evidenze<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Linee guida CLSI<\/b><span style=\"font-weight: 400\"> \u2013 EP05, EP07, EP17, EP25 e altre<\/span><\/li>\n<li style=\"font-weight: 400\"><b>ISO 13485 QMS<\/b><span style=\"font-weight: 400\"> e <\/span><b>GSPR<\/b><span style=\"font-weight: 400\"> (UE)<\/span><\/li>\n<li style=\"font-weight: 400\"><b>ISO 15189<\/b><span style=\"font-weight: 400\"> standard di laboratorio<\/span><\/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<section class=\"table\"><div class=\"container\"><div class=\"headline\">Perch\u00e9 scegliere MDx CRO?<\/div><div class=\"table-wrapper\"><div class=\"feature-column-wrapper\"><table class=\"feature-table\"><thead><tr><th class=\"feature-column\">Capacit\u00e0<\/th><\/tr><\/thead><tbody><tr><td class=\"feature-cell\"><strong>Validazione del metodo analitico<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Esperienza IVDR e FDA<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Conformit\u00e0 alle linee guida CLSI<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Sviluppo APR<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Competenza nei test<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Progettazione dello studio di stabilit\u00e0<\/strong><\/td><\/tr><\/tbody><\/table><\/div><div class=\"scrollable-columns-wrapper\"><table class=\"comparison-table\"><thead><tr><th class=\"column highlight\">Il vantaggio di MDx CRO<\/th><th class=\"column\">CRO Tipiche<\/th><\/tr><\/thead><tbody><tr><td class=\"cell highlight\">Sviluppati internamente, protocolli su misura<\/td><td class=\"cell\">Spesso generici<\/td><\/tr><tr><td class=\"cell highlight\">Esperienza comprovata, la maggior parte delle tecnologie<\/td><td class=\"cell\">Limitata<\/td><\/tr><tr><td class=\"cell highlight\">Allineamento FDA ed UE<\/td><td class=\"cell\">Parziale<\/td><\/tr><tr><td class=\"cell highlight\">Supporto completo, formattazione IVDR<\/td><td class=\"cell\">Raramente offerto<\/td><\/tr><tr><td class=\"cell highlight\">PCR, NGS, IHC, SaMD, saggi immunologici, flusso laterale, ecc.<\/td><td class=\"cell\">Limitata dalla tecnologia<\/td><\/tr><tr><td class=\"cell highlight\">In tempo reale e accelerata, supporto completo<\/td><td class=\"cell\">Raramente offerto<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n<section id=\"block_7810047c8d1ff3e3cf7e8927a8d9868b\" class=\"text-image text-image--background-frost-white\" style=\"padding-top: var(--wp--preset--spacing--medium); padding-bottom: var(--wp--preset--spacing--medium); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Risultati che Contano<\/h2><div class=\"description wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><b>Tasso di successo del 100%<\/b><span style=\"font-weight: 400\">: Nessun rilievo importante da parte degli Organismi Notificati nella progettazione degli studi analitici<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Oltre 40 progetti<\/b><span style=\"font-weight: 400\">: Studi sulle prestazioni analitiche per IVD, CDx e diagnostica digitale<\/span><\/li>\n<\/ul>\n<p><b>Scelto dai primi 10 produttori di IVD<\/b><span style=\"font-weight: 400\">, aziende diagnostiche in fase iniziale e di medie dimensioni<\/span><\/p>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/yaiza-hugo-scaled.jpg\" alt=\"Innovative MedTech collaboration, professionals discussing medical technology advancements, representing MDX&#039;s role in accelerating medical innovation and healthcare solutions.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_2f7b854aab273ba5eaecabbfe19aea6d\" 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\">Testimonianze dei Clienti<\/div>\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">&#8220;MDx\u2019s analytical validation expertise enabled us to secure IVDR approval with zero major findings. Their tailored protocols and responsive team made all the difference.&#8221;<\/p>\n                                                                            <p class=\"author\">\n                                Regulatory Affairs Director, Global IVD Manufacturer                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">&#8220;As a US-based diagnostics company, MDx CRO was our bridge to European IVDR compliance. Their analytical study design team and APR support were world-class.&#8221;<\/p>\n                                                                            <p class=\"author\">\n                                VP, Clinical Development, Molecular Diagnostics SME                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">&#8220;MDx helped us navigate analytical validation under very tight timelines. Their team was hands-on, pragmatic, and always available when issues came up.&#8221;<\/p>\n                                                                            <p class=\"author\">\n                                Director of Clinical Operations                                                                <br>\n                                European IVD Company                                        \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<section id=\"block_05b9b22e2db82539dbc33c0ba2e65b5c\" 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\">Qual \u00e8 la differenza tra validazione analitica e clinica?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">La validazione analitica conferma che un IVD misura in modo accurato, affidabile e coerente l&#8217;analita di interesse (ad esempio, sensibilit\u00e0, specificit\u00e0, precisione). La validazione clinica valuta quanto bene il test identifica una condizione clinica nella popolazione target. Entrambe sono richieste per le sottomissioni IVDR e FDA.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">MDx pu\u00f2 aiutare con la creazione di APR e Rapporti sulle prestazioni analitiche IVDR?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">S\u00ec. Forniamo lo sviluppo completo dell&#8217;APR, inclusa l&#8217;analisi statistica, la stesura del riepilogo e la formattazione per i requisiti IVDR e FDA. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Supportate la documentazione conforme al CLSI?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Assolutamente. I nostri protocolli e rapporti sono allineati agli standard CLSI (EP05, EP17, EP25, ecc.), garantendo l&#8217;accettazione normativa globale. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Quali tipi di tecnologie supportate?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Copriamo PCR, NGS, saggi immunologici, IHC, multiplex, flusso laterale, SaMD e altro ancora.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">In quanto tempo pu\u00f2 essere completato uno studio di validazione analitica?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Le tempistiche dipendono dalla complessit\u00e0 del test e dalla disponibilit\u00e0 dei campioni, ma la maggior parte degli studi viene completata in 2-6 mesi con la gestione del progetto di MDx CRO.<\/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\":\"Qual \u00e8 la differenza tra validazione analitica e clinica?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"La validazione analitica conferma che un IVD misura in modo accurato, affidabile e coerente l&#8217;analita di interesse (ad esempio, sensibilit\u00e0, specificit\u00e0, precisione). 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