{"id":12071,"date":"2025-07-30T07:24:22","date_gmt":"2025-07-30T07:24:22","guid":{"rendered":"https:\/\/mdxcro.com\/services\/medecine-de-precision-diagnostics-daccompagnement\/"},"modified":"2026-07-22T10:09:10","modified_gmt":"2026-07-22T10:09:10","slug":"medecine-de-precision-diagnostic-compagnon","status":"publish","type":"service","link":"https:\/\/mdxcro.com\/fr\/services\/medecine-de-precision-diagnostic-compagnon\/","title":{"rendered":"M\u00e9decine de pr\u00e9cision et CDx"},"content":{"rendered":"\n<section id=\"block_b7f408936afe21fd82e39e4f44f7ec6e\" 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\">Votre partenaire de pr\u00e9cision pour les diagnostics compagnons et les essais bas\u00e9s sur les biomarqueurs<\/h1>\n            \n                            <div class=\"description\"><p><span style=\"font-weight: 400;\">MDx CRO est une CRO sp\u00e9cialis\u00e9e en m\u00e9decine de pr\u00e9cision et diagnostics compagnons, aidant les \u00e9quipes IVD et pharmaceutiques \u00e0 concevoir et r\u00e9aliser des \u00e9tudes cliniques CDx. Nous g\u00e9rons le d\u00e9veloppement des CDx, de la validation des biomarqueurs \u00e0 la conformit\u00e9 IVDR, en passant par les soumissions Q-sub de la FDA et l\u2019ex\u00e9cution clinique conforme \u00e0 la norme ISO 20916. <\/span><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_source=prec_med_cdx\" class=\"button bouton--par d\u00e9faut\" target=\"_self\">\n                            R\u00e9server une consultation CDx                        <\/a>\n                                            <a href=\"#popup-7743\" class=\"button bouton--secondaire\" target=\"_self\">\n                            T\u00e9l\u00e9charger le PDF des services CDx                        <\/a>\n                                    <\/div>\n                                    <\/div>\n            <\/div>\n            <div class=\"hero__form-col mdx-form-wrapper\">\n    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Nous alignons la strat\u00e9gie des biomarqueurs et la validation des essais sur l\u2019<strong>Annexe XIV de l\u2019IVDR<\/strong> et les <strong>voies de soumission FDA PMA\/Q-sub<\/strong> afin d\u2019acc\u00e9l\u00e9rer l\u2019acc\u00e8s au march\u00e9 en Europe (UE\/UK) et aux \u00c9tats-Unis. <\/p>\n<p data-start=\"1804\" data-end=\"2126\">De la s\u00e9lection de la voie SRD vs NSRD et la pr\u00e9paration des Q-sub \u00e0 la conception et au suivi des \u00e9tudes ISO 20916, notre \u00e9quipe assure une ex\u00e9cution <strong>CRO CDx de bout en bout<\/strong>, incluant la d\u00e9l\u00e9gation de promoteur et les services de repr\u00e9sentant l\u00e9gal UE\/UK.<\/p>\n<\/div><a class=\"button\" href=\"https:\/\/mdxcro.com\/fr\/contact\/\" target=\"_self\">D\u00e9couvrez comment planifier une PSA selon l\u2019Annexe XIV de l\u2019IVDR<\/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_d9cd252fa3ad9782c2cfb9326c09a1f9\" class=\"flip-cards flip-cards--three-columns flip-cards--grayscale \" style=\"\">\n            <div class=\"container\">\n        <div class=\"content\">\n                            <h3 class=\"subtitle\">Votre parcours de diagnostic compagnon<br \/>Enti\u00e8rement g\u00e9r\u00e9, \u00e9tape par \u00e9tape<\/h3>\n            \n                            <h2 class=\"title\">UN SEUL OBJECTIF<\/h2>\n            \n                            <div class=\"teaser wysiwyg\"><p>Des approbations r\u00e9glementaires sans d\u00e9lai. Premier patient, premier \u00e9chantillon \u2014 plus rapidement.<\/p>\n<\/div>\n            \n                            <div class=\"description wysiwyg\"><p>Nous guidons les promoteurs de m\u00e9decine de pr\u00e9cision \u00e0 travers chaque phase critique, en alignant les flux de travail cliniques, r\u00e9glementaires et op\u00e9rationnels pour acc\u00e9l\u00e9rer votre chemin vers l\u2019approbation.<\/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\">Strat\u00e9gie clinique CDx et feuille de route r\u00e9glementaire (FDA + IVDR)<\/div>\n                        <div class=\"back\"><p>D\u00e9finissez votre voie de d\u00e9veloppement gr\u00e2ce aux conseils d\u2019experts sur les exigences de la FDA et de l\u2019IVDR \u2014 y compris les d\u00e9terminations <strong>SRD vs NSRD<\/strong>, les r\u00e9unions Q-sub et les soumissions PMA. Notre intelligence r\u00e9glementaire couvre les \u00c9tats-Unis et l\u2019UE. <\/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\">Validation des biomarqueurs et des essais<\/div>\n                        <div class=\"back\"><p>Soutien \u00e0 la d\u00e9couverte de biomarqueurs, au d\u00e9veloppement d\u2019essais pour les essais cliniques, \u00e0 la validation analytique et \u00e0 la strat\u00e9gie de biomarqueurs translationnels. Comprend la validation d\u2019essais pour les plateformes qPCR, NGS, IHC et 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\">Audit pr\u00e9alable des laboratoires et partenaires de diagnostic<\/div>\n                        <div class=\"back\"><p>Nous qualifions les laboratoires prestataires, les LDT et les sites d\u2019essais selon la norme ISO 15189 et les exigences du marquage CE, en effectuant un audit pr\u00e9alable pour l\u2019ad\u00e9quation des tests et la conformit\u00e9 \u00e0 l\u2019IVDR pour les <strong data-start=\"3134\" data-end=\"3159\">essais cliniques<\/strong> destin\u00e9s \u00e0 des revendications <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\">Conception d\u2019\u00e9tudes cliniques et d\u00e9l\u00e9gation de promoteur<\/div>\n                        <div class=\"back\"><p>De la d\u00e9finition du CPSP et des crit\u00e8res d\u2019\u00e9valuation \u00e0 la gestion des risques et au consentement \u00e9clair\u00e9, nous concevons et r\u00e9alisons des <a href=\"https:\/\/mdxcro.com\/fr\/?post_type=service&#038;p=12057\"><strong>essais cliniques conformes \u00e0 la norme ISO 20916<\/strong><\/a>. MDx peut agir en tant que votre <a href=\"https:\/\/mdxcro.com\/fr\/?post_type=service&#038;p=12060\">repr\u00e9sentant l\u00e9gal 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\">Gestion et suivi des sites d\u2019essais (ISO 20916)<\/div>\n                        <div class=\"back\"><p>Op\u00e9rations cliniques de bout en bout \u2014 qualification des sites, formation, suivi et pr\u00e9paration aux audits \u2014 garantissant le respect du protocole et l\u2019alignement BPC avec le suivi sur site et \u00e0 distance <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\">Collecte de donn\u00e9es, biostatistiques et rapports conformes \u00e0 l\u2019IVDR<\/div>\n                        <div class=\"back\"><p>Nous g\u00e9rons la conception des eCRF, l\u2019analyse statistique et l\u2019\u00e9laboration des rapports d\u2019\u00e9tudes de performance clinique pour les soumissions IVDR, y compris les <strong data-start=\"3620\" data-end=\"3658\">rapports d\u2019\u00e9tudes de performance clinique<\/strong> pour l\u2019<strong data-start=\"3663\" data-end=\"3681\">Annexe XIV de l\u2019IVDR.<\/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\">Soumissions r\u00e9glementaires (UE &amp; USA)<\/div>\n                        <div class=\"back\"><p>Des <a href=\"https:\/\/mdxcro.com\/fr\/services\/affaires-reglementaires-documentation-technique\/\"><strong>dossiers FDA PMA &#038; Q-submission<\/strong><\/a> aux demandes relatives \u00e0 l\u2019Annexe XIV de l\u2019IVDR, nous g\u00e9rons toutes les communications avec les comit\u00e9s d\u2019\u00e9thique et les autorit\u00e9s comp\u00e9tentes, les RFI et les modifications.<\/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\">\u00c9valuation et rapport de s\u00e9curit\u00e9<\/div>\n                        <div class=\"back\"><p>Classification et r\u00e9ponse aux \u00e9v\u00e9nements ind\u00e9sirables, y compris les communications avec les organismes notifi\u00e9s et les comit\u00e9s d\u2019\u00e9thique. Couvre les rapports de s\u00e9curit\u00e9 IVDR dans les essais cliniques. <\/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\">Ce qui distingue notre CRO CDx pour les promoteurs de m\u00e9decine de pr\u00e9cision<\/div><div class=\"table-wrapper\"><div class=\"feature-column-wrapper\"><table class=\"feature-table\"><thead><tr><th class=\"feature-column\">Fonctionnalit\u00e9 ou capacit\u00e9<\/th><\/tr><\/thead><tbody><tr><td class=\"feature-cell\">Soutien aux soumissions IVDR Annexe XIV (CDx)<\/td><\/tr><tr><td class=\"feature-cell\">Conseil CDx (FDA + UE)<\/td><\/tr><tr><td class=\"feature-cell\">Suivi ISO 20916 (CDx)<\/td><\/tr><tr><td class=\"feature-cell\">D\u00e9l\u00e9gation de promoteur &amp; Repr\u00e9sentant l\u00e9gal UE\/UK<\/td><\/tr><tr><td class=\"feature-cell\">D\u00e9veloppement de la documentation IVD<\/td><\/tr><tr><td class=\"feature-cell\">Expertise translationnelle et biomarqueurs<\/td><\/tr><tr><td class=\"feature-cell\">Veille r\u00e9glementaire<\/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\">Autres CRO<\/th><th class=\"column\">\u00c9quipes internes<\/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=\"\">Bilan \u00e9prouv\u00e9<\/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=\"\">Limit\u00e9 ou externalis\u00e9<\/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=\"\">Rarement exp\u00e9riment\u00e9<\/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=\"\">Sp\u00e9cialis\u00e9 en 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=\"\">G\u00e9n\u00e9ralistes<\/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=\"\">Gourmand en ressources<\/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=\"\">Experts en laboratoire internes<\/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=\"\">Manque d\u2019expertise en laboratoire<\/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 autoris\u00e9<\/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=\"\">Couverture compl\u00e8te 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=\"\">Partielle ou locale uniquement<\/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 autoris\u00e9<\/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=\"\">D\u00e9velopp\u00e9 en interne<\/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=\"\">Externalis\u00e9<\/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=\"\">Lacunes en expertise<\/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=\"\">Oncologie, maladies rares, 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=\"\">Profondeur limit\u00e9e<\/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=\"\">Pas toujours sp\u00e9cialis\u00e9<\/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=\"\">Base de donn\u00e9es 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\u00e9 partielle<\/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=\"\">Bande passante limit\u00e9e<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n<section id=\"block_be9a22cc4e5b9ae0e4fef1c48e35b46e\" class=\"content-columns content-columns--three-columns \" style=\"\">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">Domaines th\u00e9rapeutiques et technologies<\/h2>\n                                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Focus th\u00e9rapeutique<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Oncologie<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">CPNPC, HPV, cancer du sein, tumeurs PIWIL1+, tumeurs avec d\u00e9l\u00e9tion de MTAP, cancer colorectal<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Troubles r\u00e9tiniens et h\u00e9r\u00e9ditaires<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Th\u00e9rapie g\u00e9nique et cellulaire<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Syndromes my\u00e9lodysplasiques<\/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\">Technologies et plateformes<\/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\">Panneaux NGS, biopsie liquide<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Immunoessais (ex. AAV8)<\/span><\/li>\n<li style=\"font-weight: 400\">Essais de diagnostics compagnons (NGS, qPCR, IHC)<\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">SaMD \/ Diagnostics num\u00e9riques<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">S\u00e9quen\u00e7age 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\">Applications des biomarqueurs<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Biomarqueurs pr\u00e9dictifs et pronostiques<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Essais diagnostiques<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Logiciel CDx<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">D\u00e9veloppement d\u2019essais translationnels<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n\n<section id=\"block_92c1ee70cfbcc748a045bbfd930835a9\" 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\">Ce que disent nos clients<\/div>\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0Delegating 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.\u00a0\u00bb<\/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\">\u00ab\u00a0MDx\u2019s clinical and regulatory knowledge filled critical gaps. Their team worked tirelessly to help us reach IVD study approvals across Europe.\u00a0\u00bb<\/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\">\u00ab\u00a0Truly the EU extension of our team. Their responsiveness and attention to detail drove our CDx transition success.\u00a0\u00bb<\/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\">\u00ab\u00a0We 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.\u00a0\u00bb<\/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_394cdcd4656a27444334ed71770b1c34\" 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\">Qui nous servons<\/h2><div class=\"description wysiwyg\"><ul>\n<li>Entreprises pharmaceutiques mondiales co-d\u00e9veloppant des diagnostics compagnons<\/li>\n<li>Fabricants d\u2019IVD et de CDx<\/li>\n<li>D\u00e9veloppeurs de diagnostics ax\u00e9s sur l\u2019oncologie<\/li>\n<li>Promoteurs bas\u00e9s aux \u00c9tats-Unis r\u00e9alisant des \u00e9tudes cliniques de diagnostics compagnons en Europe<\/li>\n<li><a href=\"https:\/\/mdxcro.com\/fr\/services\/logiciel-sante-numerique-ia\/\">Plateformes de diagnostic num\u00e9rique et logicielles<\/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\">Notre bilan en chiffres<\/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\">\u00c9tudes combin\u00e9es<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">400+<\/div>\n                                                  <div class=\"legend\">Documents essentiels \u00e9labor\u00e9s<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">Phases I-III<\/div>\n                                                  <div class=\"legend\">Essais cliniques<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">UE27\/UK<\/div>\n                                                  <div class=\"legend\">soumissions<\/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>Programmes CDx commerciaux livr\u00e9s<\/b><\/p>\n<p><span style=\"font-weight: 400\">MDx a soutenu avec succ\u00e8s l\u2019ex\u00e9cution d\u2019\u00e9tudes de performance et les soumissions r\u00e9glementaires pour des programmes CDx commercialis\u00e9s dans le monde entier.<\/span><\/p>\n<p>Nous accompagnons les diagnostics compagnons de la validation clinique aux demandes FDA PMA\/Q-sub et IVDR Annexe XIV, en alignant les calendriers CDx sur le d\u00e9veloppement des m\u00e9dicaments, y compris les <a href=\"https:\/\/mdxcro.com\/companion-diagnostics-consultancy-in-the-eu-a-comprehensive-guide\/\"><b>consultations avec l\u2019EMA et les organismes notifi\u00e9s.<\/b><\/a><\/p>\n        <\/div>\n      \n              <div class=\"description wysiwyg\">\n          <p><span style=\"font-weight: 400\">Notre exp\u00e9rience inclut :<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>Essais IHC HER2<\/b><span style=\"font-weight: 400\"> pour les cancers du sein et de l\u2019estomac<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Kits de d\u00e9tection de mutation EGFR<\/b><span style=\"font-weight: 400\"> pour le CPNPC<\/span><\/li>\n<li style=\"font-weight: 400\"><a href=\"https:\/\/mdxcro.com\/fr\/services\/services-ngs\/\"><b>Panneaux NGS<\/b><\/a><span style=\"font-weight: 400\"><strong> avec revendications CDx<\/strong> (cancer colorectal et tumeurs solides)<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Essais qPCR et multiplex<\/b><span style=\"font-weight: 400\"> valid\u00e9s sous IVDR et FDA<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n        <\/div>\n          <\/div>\n  <\/div>\n<\/section>\n<section id=\"block_de08e79cbb11a26676e2f6ee7cc64b6a\" class=\"faqs\" style=\"padding-top: Par d\u00e9faut; padding-bottom: Par d\u00e9faut; margin-top: Par d\u00e9faut; margin-bottom: Par d\u00e9faut; \">\n    <div class=\"container\">\n    <div class=\"content\">\n      <div class=\"column\">\n                  <h2 class=\"headline\">Questions fr\u00e9quemment pos\u00e9es<\/h2>\n                          <a class=\"button bouton--quaternaire\" href=\"https:\/\/mdxcro.com\/fr\/contact\/\" target=\"\">\n            Posez-nous une question          <\/a>\n              <\/div>\n      <div class=\"column\">\n                  <ul class=\"faq-list\">\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Qu\u2019est-ce que la d\u00e9cision SRD vs NSRD pour les CDx aux \u00c9tats-Unis ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>La FDA distingue les \u00e9tudes sur les <strong data-start=\"6266\" data-end=\"6299\">dispositifs \u00e0 risque important (SRD)<\/strong> des \u00e9tudes sur les <strong data-start=\"6305\" data-end=\"6343\">dispositifs \u00e0 risque non important (NSRD)<\/strong>. Nous guidons les promoteurs de CDx \u00e0 travers les interactions <strong data-start=\"6383\" data-end=\"6392\">Q-sub<\/strong> et d\u00e9terminons la voie appropri\u00e9e vers la <strong data-start=\"6442\" data-end=\"6449\">PMA<\/strong> ou d\u2019autres soumissions. <\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Qu\u2019est-ce que l\u2019Annexe XIV de l\u2019IVDR pour les diagnostics compagnons ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>L\u2019Annexe XIV d\u00e9finit les exigences relatives aux <strong data-start=\"5956\" data-end=\"5986\">\u00e9tudes de performance clinique<\/strong> pour les DIV, y compris les <strong data-start=\"6020\" data-end=\"6027\">CDx<\/strong>, dans l\u2019UE. Elle couvre les soumissions, les processus des comit\u00e9s d\u2019\u00e9thique et des autorit\u00e9s comp\u00e9tentes, ainsi que les attentes en mati\u00e8re de preuves pour l\u2019\u00e9valuation de la conformit\u00e9 <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 peut-elle agir en tant que repr\u00e9sentant l\u00e9gal pour les \u00e9tudes de performance CDx et IVDR dans l\u2019UE ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Oui. Nous proposons des services de d\u00e9l\u00e9gation de promoteur, des soumissions aux comit\u00e9s d\u2019\u00e9thique et aux autorit\u00e9s comp\u00e9tentes, ainsi qu\u2019une <a href=\"https:\/\/mdxcro.com\/fr\/?post_type=service&amp;p=12060\">repr\u00e9sentation l\u00e9gale<\/a> \u2014 en g\u00e9rant la documentation et les communications en votre nom.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Prenez-vous en charge \u00e0 la fois l\u2019IVDR et les soumissions FDA PMA ou Q-sub pour les CDx ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Absolument. Nous d\u00e9finissons les strat\u00e9gies de soumission, coordonnons la g\u00e9n\u00e9ration de preuves et g\u00e9rons les communications de bout en bout avec les organismes notifi\u00e9s de l\u2019UE, l\u2019EMA et la FDA, y compris les <strong data-start=\"6568\" data-end=\"6593\">soumissions FDA PMA\/Q-sub<\/strong> et les demandes relatives \u00e0 l\u2019<strong data-start=\"6598\" data-end=\"6616\">Annexe XIV de l\u2019IVDR<\/strong>. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Quels sont les d\u00e9fis lors de la r\u00e9alisation d\u2019\u00e9tudes combin\u00e9es sous CTR et IVDR ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Les \u00e9tudes combin\u00e9es font face \u00e0 un d\u00e9salignement r\u00e9glementaire \u2014 l\u2019IVDR et le CTR ont des exigences, des calendriers et des voies de soumission diff\u00e9rents. MDx aide les promoteurs \u00e0 naviguer dans ces complexit\u00e9s en d\u00e9veloppant des strat\u00e9gies int\u00e9gr\u00e9es, garantissant que les donn\u00e9es cliniques et de performance r\u00e9pondent aux attentes distinctes des r\u00e9gulateurs des dispositifs m\u00e9dicaux et des produits m\u00e9dicinaux. <\/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\":\"Qu\u2019est-ce que la d\u00e9cision SRD vs NSRD pour les CDx aux \u00c9tats-Unis ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"La FDA distingue les \u00e9tudes sur les dispositifs \u00e0 risque important (SRD) des \u00e9tudes sur les dispositifs \u00e0 risque non important (NSRD). 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Nous d\u00e9finissons les strat\u00e9gies de soumission, coordonnons la g\u00e9n\u00e9ration de preuves et g\u00e9rons les communications de bout en bout avec les organismes notifi\u00e9s de l\u2019UE, l\u2019EMA et la FDA, y compris les soumissions FDA PMA\/Q-sub et les demandes relatives \u00e0 l\u2019Annexe XIV de l\u2019IVDR.\"}},{\"@type\":\"Question\",\"name\":\"Quels sont les d\u00e9fis lors de la r\u00e9alisation d\u2019\u00e9tudes combin\u00e9es sous CTR et IVDR ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Les \u00e9tudes combin\u00e9es font face \u00e0 un d\u00e9salignement r\u00e9glementaire \u2014 l\u2019IVDR et le CTR ont des exigences, des calendriers et des voies de soumission diff\u00e9rents. MDx aide les promoteurs \u00e0 naviguer dans ces complexit\u00e9s en d\u00e9veloppant des strat\u00e9gies int\u00e9gr\u00e9es, garantissant que les donn\u00e9es cliniques et de performance r\u00e9pondent aux attentes distinctes des r\u00e9gulateurs des dispositifs m\u00e9dicaux et des produits m\u00e9dicinaux.\"}}]}  <\/script>\n\n<section id=\"block_e472168a1649b802a203426e60b646c8\" class=\"call-to-action\" style=\"padding-top: Par d\u00e9faut; padding-bottom: Par d\u00e9faut; margin-top: Par d\u00e9faut; margin-bottom: Par d\u00e9faut; \">\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\">Acc\u00e9l\u00e9rons la mise sur le march\u00e9 de votre CDx<\/h2>\n                \n                                    <div class=\"description wysiwyg\">\n                        <p>Que vous co-d\u00e9veloppiez un CDx avec un partenaire pharmaceutique ou que vous pr\u00e9pariez votre premi\u00e8re soumission \u00e0 l\u2019Annexe XIV de l\u2019IVDR, MDx est votre CRO de diagnostics compagnons \u00e0 service complet pour le succ\u00e8s r\u00e9glementaire et l\u2019approbation mondiale, offrant des \u00e9tudes ISO 20916, une repr\u00e9sentation l\u00e9gale UE\/UK et un soutien FDA PMA\/Q-sub.<\/p>\n<p><b>Votre CDx. Notre expertise. Un impact mondial.  <\/b><\/p>\n                    <\/div>\n                            <\/div>\n\n                            <div class=\"button-wrapper\">\n                                                                        <a href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_source=prec_med_cdx\" class=\"button button--tertiary\" target=\"\">\n                                R\u00e9server une consultation 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-12071","service","type-service","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CRO en diagnostics compagnons | Services CDx IVDR &amp; FDA | MDx CRO<\/title>\n<meta name=\"description\" content=\"CRO en diagnostics compagnons pour les programmes CDx IVDR Annexe XIV, ISO 20916 &amp; FDA PMA. D\u2019anciens \u00e9valuateurs d\u2019organismes notifi\u00e9s dirigent les \u00e9tudes de performance clinique CDx de bout en bout.\" \/>\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\/fr\/services\/medecine-de-precision-diagnostic-compagnon\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CRO en diagnostics compagnons | Services CDx IVDR &amp; FDA | MDx CRO\" \/>\n<meta property=\"og:description\" content=\"CRO en diagnostics compagnons pour les programmes CDx IVDR Annexe XIV, ISO 20916 &amp; FDA PMA. 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