{"id":7731,"date":"2023-02-07T13:31:45","date_gmt":"2023-02-07T13:31:45","guid":{"rendered":"https:\/\/www.biotrial.com?page_id=7731"},"modified":"2024-10-11T13:59:49","modified_gmt":"2024-10-11T13:59:49","slug":"essais-cliniques-specialises-de-phase-i","status":"publish","type":"page","link":"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/services-cliniques\/essais-cliniques-specialises-de-phase-i\/","title":{"rendered":"Essais cliniques sp\u00e9cialis\u00e9s de Phase I"},"content":{"rendered":"\n    <section class=\"acf anchors-depth-3 positionStickyElement\" id=\"\">\n        <div class=\"container\">\n            <div class=\"left\">\n                                    <a href=\"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/services-cliniques\/\" class=\"link return\">Retour<\/a>\n                            <\/div>\n            <div class=\"right\">\n                                    <a class=\"anchor\" href=\"#blockSolutions\">\n                        <span>\u00c9tudes de TQT\/QTc <\/span>\n                    <\/a>\n                                    <a class=\"anchor\" href=\"#blockbridging\">\n                        <span>\u00c9tudes de transition<\/span>\n                    <\/a>\n                                    <a class=\"anchor\" href=\"#blockInformation\">\n                        <span>D\u00e9couvrir \u00e9galement<\/span>\n                    <\/a>\n                            <\/div>\n        <\/div>\n    <\/section>\n\n\n\n<section class=\"acf header-depth-3\" id=\"\">\n    <div class=\"container large\">\n                    <div class=\"container\">\n                <div class=\"content\">\n                                            <h1>Essais cliniques sp\u00e9cialis\u00e9s de Phase I<\/h1>\n                                                                <p>Biotrial se sp\u00e9cialise dans les essais cliniques de Phase I sur des volontaires sains. Nos experts accompagnent nos clients dans le d\u00e9veloppement de leur m\u00e9dicament en respectant les d\u00e9lais, sans compromettre la qualit\u00e9 de service.<\/p>\n<p>Nous offrons \u00e9galement toute une gamme de services compl\u00e9mentaires pour les essais cliniques, y compris :<\/p>\n<ul>\n<li>Gestion des donn\u00e9es<\/li>\n<li>Affaires r\u00e9glementaires<\/li>\n<li>Pharmacovigilance \/ Monitoring m\u00e9dical<\/li>\n<\/ul>\n\n                                    <\/div>\n            <\/div>\n                            <picture>\n                <source type=\"image\/webp\"\n                    srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/02\/biotrial_clinical_medialdevice1-1060x400.webp, https:\/\/www.biotrial.com\/app\/uploads\/2023\/02\/biotrial_clinical_medialdevice1-1060x400@2x.webp 2x\">\n                <source type=\"image\/jpeg\"\n                    srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/02\/biotrial_clinical_medialdevice1-1060x400.jpg, https:\/\/www.biotrial.com\/app\/uploads\/2023\/02\/biotrial_clinical_medialdevice1-1060x400@2x.jpg 2x\">\n                <img decoding=\"async\" src=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/02\/biotrial_clinical_medialdevice1-1060x400.jpg\" alt=\"\"\n                    width=\"1060\" height=\"400\" loading=\"lazy\" \/>\n            <\/picture>\n            <\/div>\n<\/section>\n\n\n<section class=\"acf text-rounded-image\" style=\"background-color:#5cb898\" id=\"blockSolutions\">\n    <div class=\"container\">\n                    <div class=\"left\">\n                <picture>\n                    <source type=\"image\/webp\"\n                        srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/04\/istock-1208380119-scaled-540x540-c-default.webp, https:\/\/www.biotrial.com\/app\/uploads\/2023\/04\/istock-1208380119-scaled-540x540-c-default@2x.webp 2x\">\n                    <source type=\"image\/jpeg\"\n                        srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/04\/istock-1208380119-scaled-540x540-c-default.jpg, https:\/\/www.biotrial.com\/app\/uploads\/2023\/04\/istock-1208380119-scaled-540x540-c-default@2x.jpg 2x\">\n                    <img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/04\/istock-1208380119-scaled-540x540-c-default.jpg\" alt=\"\"\n                        width=\"540\" height=\"540\" \/>\n                <\/picture>\n            <\/div>\n                <div class=\"right\">\n                            <h2>\u00c9tudes de prolongation du QT (TQT)\/QTc<\/h2>\n                                        <p>Biotrial poss\u00e8de une vaste exp\u00e9rience dans la r\u00e9alisation d&#8217;\u00e9tudes TQT\/QTc ainsi que dans les essais de phase I (SAD, MAD, DDI) incluant des crit\u00e8res d&#8217;\u00e9valuation du QT. Depuis l&#8217;introduction des directives ICH E14, Biotrial a men\u00e9 de nombreuses \u00e9tudes TQT\/QTc et a d\u00e9velopp\u00e9 une expertise approfondie dans la capture et l&#8217;analyse des ECG et du QT\/QTc.<\/p>\n<p>Reconnu comme un expert en exploration du QT, Biotrial dispose de plus de<strong> 35 ans d&#8217;exp\u00e9rience<\/strong> dans les services de s\u00e9curit\u00e9 cardiaque. Nous accompagnons nos sponsors pour en int\u00e9grant des mesures pr\u00e9coces de s\u00e9curit\u00e9 cardiaque (exploration pr\u00e9coce du QT) ou en r\u00e9alisant une \u00e9tude compl\u00e8te de prolongation du QT (TQT).<\/p>\n<p>Certains sponsors choisissent d&#8217;ajouter une \u00e9valuation pr\u00e9coce de la s\u00e9curit\u00e9 cardiaque \u00e0 leurs premi\u00e8res \u00e9tudes chez l&#8217;homme, tandis que d&#8217;autres attendent une phase de d\u00e9veloppement plus avanc\u00e9e pour r\u00e9aliser une \u00e9tude approfondie de l&#8217;allongement de l&#8217;intervalle QT.<\/p>\n<p>Nous concevons et menons des \u00e9tudes QT depuis que les directives <strong>FDA E14<\/strong> ont \u00e9t\u00e9 finalis\u00e9es. Nos \u00e9quipes d&#8217;experts poss\u00e8dent une <strong>exp\u00e9rience significative<\/strong> \u00e0 la fois dans l&#8217;\u00e9valuation pr\u00e9coce de la s\u00e9curit\u00e9 cardiaque et dans les \u00e9tudes compl\u00e8tes de prolongation du QT.<\/p>\n<p><strong>Avec des centaines d&#8217;\u00e9tudes ECG\/TQT \u00e0 son actif<\/strong>, Biotrial peut adapter son approche pour r\u00e9pondre aux besoins sp\u00e9cifiques des sponsors en passant par le choix du design de l&#8217;\u00e9tude, la population de volontaires, le type d&#8217;enregistrement ECG ou l&#8217;analyse des donn\u00e9es. Nos \u00e9quipes de cardiologues sont \u00e0 votre disposition pour vous conseiller et optimiser l&#8217;efficacit\u00e9 de vos \u00e9tudes TQT.<\/p>\n\n                    <\/div>\n    <\/div>\n<\/section>\n\n<section class=\"core core-media-text\" ><div class=\"container\">\n<div class=\"wp-block-media-text alignwide is-stacked-on-mobile is-style-img-is-rounded\"><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/02\/biotrial_clincal_vaccinetrials-1024x683.jpg\" alt=\"Unrecognizable Girl Receives Flu Shot\" class=\"wp-image-1513 size-full\" srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/02\/biotrial_clincal_vaccinetrials-1024x683.jpg 1024w, https:\/\/www.biotrial.com\/app\/uploads\/2023\/02\/biotrial_clincal_vaccinetrials-300x200.jpg 300w, https:\/\/www.biotrial.com\/app\/uploads\/2023\/02\/biotrial_clincal_vaccinetrials-768x512.jpg 768w, https:\/\/www.biotrial.com\/app\/uploads\/2023\/02\/biotrial_clincal_vaccinetrials-1536x1024.jpg 1536w, https:\/\/www.biotrial.com\/app\/uploads\/2023\/02\/biotrial_clincal_vaccinetrials-2048x1365.jpg 2048w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure><div class=\"wp-block-media-text__content\">\n<h2 class=\"wp-block-heading\"><strong>Essais sur les vaccins<\/strong><\/h2>\n\n\n\n<p>Biotrial r\u00e9alise des essais sur les vaccins pour les volontaires sains en phase I, les patients en phase II et III, visant \u00e0 \u00e9valuer la tol\u00e9rance, l&#8217;immunog\u00e9nicit\u00e9, et l&#8217;efficacit\u00e9 des nouveaux vaccins. Nous disposons de zones ambulatoires d\u00e9di\u00e9es dans nos unit\u00e9s, sp\u00e9cialement con\u00e7ues pour ces \u00e9tudes vaccins. Notre personnel est form\u00e9 aux programmes cliniques n\u00e9cessitant une surveillance importante.<\/p>\n\n\n\n<p>Nous proposons une gamme compl\u00e8te de services pour les essais sur les vaccins, comprenant notamment :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Conception de l&#8217;\u00e9tude et d\u00e9veloppement du protocole<\/li>\n\n\n\n<li>Support affaires r\u00e9glementaires<\/li>\n\n\n\n<li>Gestion de projets<\/li>\n\n\n\n<li>Gestion des donn\u00e9es m\u00e9dicales<\/li>\n\n\n\n<li>Monitoring m\u00e9dical<\/li>\n\n\n\n<li>\u00c9valuation de l&#8217;immunog\u00e9nicit\u00e9<\/li>\n\n\n\n<li>\u00c9valuation de l&#8217;efficacit\u00e9<\/li>\n<\/ul>\n\n\n\n<p>Biotrial s&#8217;adapte aux besoins sp\u00e9cifiques de chaque sponsor, que ce soit par le choix du design de l&#8217;\u00e9tude, de la population de volontaires ou de l&#8217;analyse des donn\u00e9es.<\/p>\n<\/div><\/div>\n<\/div><\/section>\n\n<div class=\"core core-columns\" ><div class=\"container\">\n<div class=\"wp-block-columns are-vertically-aligned-center is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\" id=\"blockServices\">\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<h2 class=\"wp-block-heading\"><strong>Les essais d&#8217;imagerie<\/strong><\/h2>\n\n\n\n<p>Les techniques d&#8217;imagerie m\u00e9dicale sont utiles pour d\u00e9tecter, diagnostiquer, guider ou surveiller le traitement des maladies. Ce sont des outils essentiels dans la recherche clinique pour le d\u00e9veloppement de m\u00e9dicaments.<\/p>\n\n\n\n<p>Biotrial dispose de sp\u00e9cialistes en imagerie. Avec une \u00e9quipe d\u00e9di\u00e9e de sp\u00e9cialistes de l&#8217;imagerie, de la phase I (y compris les essais r\u00e9alis\u00e9s dans nos unit\u00e9s cliniques) \u00e0 la phase IV, et dans divers domaines th\u00e9rapeutiques.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center has-gris-clair-2-background-color has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\">\n<ul class=\"wp-block-list\">\n<li>Neurologie : Scl\u00e9rose en plaques, Maladie d&#8217;Alzheimer<\/li>\n\n\n\n<li>Oncologie : RECIST 1.1, iRECIST, RANO<\/li>\n\n\n\n<li>Cardiovasculaire<\/li>\n\n\n\n<li>Troubles musculo-squelettiques<\/li>\n\n\n\n<li>Gastro-intestinal<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-large is-style-rounded\"><picture><source srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/2211023-biotrial-pdv-reportage-01-169-1024x683.webp\" type=\"image\/webp\" \/><img src=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/2211023-biotrial-pdv-reportage-01-169-1024x683.jpg\" width=\"1024\"  height=\"683\" class=\"wp-image-5263\" alt=\"2211023 Biotrial Pdv Reportage 01 169\" ><\/picture><\/figure>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div>\n\n\n<section class=\"acf text-rounded-image\" style=\"background-color:#f4b940\" id=\"blockbridging\">\n    <div class=\"container\">\n                    <div class=\"left\">\n                <picture>\n                    <source type=\"image\/webp\"\n                        srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/biotrial_clinical_bridging_studies-540x540-c-default.webp, https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/biotrial_clinical_bridging_studies-540x540-c-default@2x.webp 2x\">\n                    <source type=\"image\/jpeg\"\n                        srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/biotrial_clinical_bridging_studies-540x540-c-default.jpg, https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/biotrial_clinical_bridging_studies-540x540-c-default@2x.jpg 2x\">\n                    <img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/biotrial_clinical_bridging_studies-540x540-c-default.jpg\" alt=\"\"\n                        width=\"540\" height=\"540\" \/>\n                <\/picture>\n            <\/div>\n                <div class=\"right\">\n                            <h2>\u00c9tudes &#8220;bridging&#8221;<\/h2>\n                                        <p>Les \u00e9tudes &#8220;bridging&#8221; sont des essais cliniques suppl\u00e9mentaires r\u00e9alis\u00e9s pour obtenir l&#8217;approbation d&#8217;un m\u00e9dicament dans une nouvelle r\u00e9gion. Elles sont n\u00e9cessaires lorsqu&#8217;il existe des pr\u00e9occupations concernant les diff\u00e9rences ethniques entre la r\u00e9gion d&#8217;origine et la nouvelle r\u00e9gion, ou lorsque la formulation, les composants ou le principe actif du m\u00e9dicament changent.<\/p>\n<p>Si vous envisagez de mener une \u00e9tude &#8220;bridging&#8221;, il est crucial de <strong>collaborer avec une CRO exp\u00e9riment\u00e9e<\/strong>. Une CRO comp\u00e9tente peut vous aider \u00e0 concevoir et r\u00e9aliser l&#8217;\u00e9tude, et vous accompagner dans le processus de soumission r\u00e9glementaire.<\/p>\n<p>Biotrial poss\u00e8de une<strong> vaste exp\u00e9rience dans les \u00e9tudes\u00a0&#8220;bridging&#8221;<\/strong>\u00a0dans divers domaines th\u00e9rapeutiques. Nous avons men\u00e9 ces essais \u00e0 l&#8217;\u00e9chelle mondiale pour des m\u00e9dicaments approuv\u00e9s aux <strong>\u00c9tats-Unis, en Europe<\/strong> et au <strong>Japon<\/strong>, ainsi que pour des m\u00e9dicaments d\u00e9velopp\u00e9s pour de nouvelles indications ou populations. Voici les avantages des&#8221;bri \u00e9tudes dging&#8221; :<\/p>\n<ul>\n<li><strong>S\u00e9curit\u00e9 et efficacit\u00e9 dans une nouvelle r\u00e9gion<\/strong> : Identifier des pr\u00e9occupations sp\u00e9cifiques \u00e0 la nouvelle r\u00e9gion pour assurer que le m\u00e9dicament est s\u00fbr et efficace pour la nouvelle population.<\/li>\n<li><strong>Acc\u00e9l\u00e9ration du processus d&#8217;approbation<\/strong> : Fournir les donn\u00e9es n\u00e9cessaires aux agences r\u00e9glementaires pour approuver un m\u00e9dicament sur un nouveau march\u00e9, acc\u00e9l\u00e9rant ainsi l&#8217;acc\u00e8s des patients au m\u00e9dicament.<\/li>\n<li><strong>R\u00e9duction des co\u00fbts de d\u00e9veloppement<\/strong> : Optimiser le processus de d\u00e9veloppement pour minimiser les d\u00e9penses tout en respectant les exigences r\u00e9glementaires et de s\u00e9curit\u00e9.<\/li>\n<\/ul>\n\n                    <\/div>\n    <\/div>\n<\/section>\n\n<section class=\"core-inline core-paragraph\" ><div class=\"container\">\n<p><\/p>\n<\/div><\/section>\n\n<div class=\"core core-columns\" ><div class=\"container\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\" id=\"BlockBiosimilars\">\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<h2 class=\"wp-block-heading\">Essais de m\u00e9dicaments biologiques\/biosimilaires<\/h2>\n\n\n\n<p><strong><strong>Favoriser le d\u00e9veloppement de nouveaux m\u00e9dicament<\/strong>s<\/strong><\/p>\n\n\n\n<p>Les essais de m\u00e9dicaments biologiques et biosimilaires sont men\u00e9s avec de grandes mol\u00e9cules d\u00e9riv\u00e9es de cellules vivantes via des processus de fabrication complexes. Ils n\u00e9cessitent des <strong>connaissances sp\u00e9cifiques<\/strong> et une strat\u00e9gie pour l&#8217;ex\u00e9cution de l&#8217;\u00e9tude.<\/p>\n\n\n\n<p>Biotrial poss\u00e8de une vaste exp\u00e9rience avec les compos\u00e9s biologiques\/biosimilaires, tels que les anticorps, les peptides, les th\u00e9rapies cellulaires\/g\u00e9niques et les vaccins. Nous avons men\u00e9 des essais de m\u00e9dicaments biologiques\/biosimilaires dans un <strong>large \u00e9ventail de domaines th\u00e9rapeutiques<\/strong>, notamment l&#8217;oncologie, les maladies cardiovasculaires et les maladies auto-immunes.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column has-gris-clair-2-background-color has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<div class=\"wp-block-columns are-vertically-aligned-center is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\">\n<ul class=\"wp-block-list\">\n<li>Expertise dans le d\u00e9veloppement des m\u00e9dicaments biologiques\/biosimilaires et exp\u00e9rience en Europe et aux \u00c9tats-Unis<\/li>\n\n\n\n<li>Installations cliniques de phase I conformes \u00e0 l&#8217;EMA et \u00e0 la FDA (capacit\u00e9 de 150 et 110 lits en France et aux \u00c9tats-Unis)<\/li>\n\n\n\n<li>Soumissions r\u00e9glementaires rapides<\/li>\n\n\n\n<li>Large bases de donn\u00e9es de volontaires <\/li>\n\n\n\n<li>Processus de haute qualit\u00e9 pour les \u00e9tudes de s\u00e9curit\u00e9 et de pharmacocin\u00e9tique<\/li>\n\n\n\n<li>R\u00e9seau pour obtenir les comparateurs conformes aux normes de l&#8217;UE et des \u00c9tats-Unis<\/li>\n\n\n\n<li>Large exp\u00e9rience dans l&#8217;analyse des donn\u00e9es des \u00e9tudes de bio\u00e9quivalence<\/li>\n\n\n\n<li>Personnel form\u00e9 aux directives de bio\u00e9quivalence\/biosimilarit\u00e9 de l&#8217;EMA et de la FDA<\/li>\n\n\n\n<li>Multiples \u00e9tudes avec des r\u00e9sultats positifs inspect\u00e9es valid\u00e9es par la FDA<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-large is-style-rounded\"><picture><source srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/2211023-biotrial-pdv-reportage-01-123-1024x768.webp\" type=\"image\/webp\" \/><img src=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/2211023-biotrial-pdv-reportage-01-123-1024x768.jpg\" width=\"1024\"  height=\"768\" class=\"wp-image-5265\" alt=\"2211023 Biotrial Pdv Reportage 01 123\" loading=\"lazy\"><\/picture><\/figure>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div>\n\n<section class=\"core core-media-text\" ><div class=\"container\">\n<div class=\"wp-block-media-text alignwide has-media-on-the-right is-stacked-on-mobile is-style-img-is-rounded has-blanc-color has-bleu-marine-background-color has-text-color has-background\" style=\"grid-template-columns:auto 43%\"><div class=\"wp-block-media-text__content\">\n<h2 class=\"wp-block-heading has-blanc-color has-text-color\">\u00c9tudes sur les insuffisants r\u00e9naux\/h\u00e9patiques<\/h2>\n\n\n\n<p><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blanc-color\">Au fil des derni\u00e8res ann\u00e9es, Biotrial a conduit de nombreuses \u00e9tudes chez les insuffisants r\u00e9naux et h\u00e9patiques, en utilisant des designs complexes, et couvrant un large \u00e9ventail de domaines th\u00e9rapeutiques.<\/mark><\/p>\n\n\n\n<p><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blanc-color\">Nous collaborons avec des sites externes pour garantir que nos patients atteints de troubles r\u00e9naux et h\u00e9patiques b\u00e9n\u00e9ficient de la supervision clinique sp\u00e9cialis\u00e9e dont ils ont besoin. Nous exploitons leurs bases de donn\u00e9es pour acc\u00e9der aux populations de patients.<\/mark><\/p>\n\n\n\n<p><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blanc-color\">Nos experts peuvent vous aider \u00e0 concevoir l&#8217;\u00e9tude conform\u00e9ment aux exigences r\u00e9glementaires. Nous s\u00e9lectionnons les meilleurs sites pour r\u00e9pondre \u00e0 vos attentes et r\u00e9aliser l&#8217;\u00e9tude dans les meilleurs d\u00e9lais.<\/mark><\/p>\n\n\n\n<p class=\"has-blanc-color has-text-color\"><\/p>\n<\/div><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/istock-1157550305-1024x683.jpg\" alt=\"Biotrial Clinical Renal Hepatic Impairment Studies\" class=\"wp-image-2381 size-full\" srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/istock-1157550305-1024x683.jpg 1024w, https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/istock-1157550305-300x200.jpg 300w, https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/istock-1157550305-768x512.jpg 768w, https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/istock-1157550305-1536x1024.jpg 1536w, https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/istock-1157550305-2048x1365.jpg 2048w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure><\/div>\n<\/div><\/section>\n\n<section class=\"core core-media-text\" ><div class=\"container\">\n<div class=\"wp-block-media-text alignwide has-media-on-the-right is-stacked-on-mobile is-style-img-is-rounded\" style=\"grid-template-columns:auto 43%\"><div class=\"wp-block-media-text__content\">\n<h2 class=\"wp-block-heading has-noir-color has-text-color\">Dispositif m\u00e9dical<\/h2>\n\n\n\n<p>Les essais cliniques des dispositifs m\u00e9dicaux sont essentiels pour garantir la tol\u00e9rance et l&#8217;efficacit\u00e9 des dispositifs avant leurs commercialisations. Ces essais sont r\u00e9alis\u00e9s dans un cadre contr\u00f4l\u00e9 pour \u00e9valuer la performance du dispositif et identifier d&#8217;\u00e9ventuels risques.<\/p>\n\n\n\n<p>Chaque ann\u00e9e, nous menons plusieurs investigations cliniques avec diff\u00e9rents profils de risque de dispositifs m\u00e9dicaux (Classe I, IIa, IIb et III) et nous suivons des r\u00e9glementations sp\u00e9cifiques pour ces essais :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Norme <strong>ISO 14155:2020<\/strong> pour la conception, la conduite, l&#8217;enregistrement et le rapport des investigations cliniques men\u00e9es sur des sujets humains pour \u00e9valuer la performance clinique ou l&#8217;efficacit\u00e9 et la s\u00e9curit\u00e9 des dispositifs m\u00e9dicaux<\/li>\n\n\n\n<li>La nouvelle r\u00e9glementation europ\u00e9enne <strong>2017\/745 <\/strong>relative aux dispositifs m\u00e9dicaux applicable depuis le 26 mai 2021 dans l&#8217;UE.<\/li>\n<\/ul>\n\n\n\n<p>.<\/p>\n<\/div><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"768\" src=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/2211023-biotrial-pdv-reportage-01-139-1024x768.jpg\" alt=\"Biotrial-clinical-phase 1\" class=\"wp-image-5267 size-full\" srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/2211023-biotrial-pdv-reportage-01-139-1024x768.jpg 1024w, https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/2211023-biotrial-pdv-reportage-01-139-300x225.jpg 300w, https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/2211023-biotrial-pdv-reportage-01-139-768x576.jpg 768w, https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/2211023-biotrial-pdv-reportage-01-139-1536x1152.jpg 1536w, https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/2211023-biotrial-pdv-reportage-01-139-2048x1536.jpg 2048w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure><\/div>\n<\/div><\/section>\n\n\n<section class=\"acf links\" id=\"blockInformation\">\n    <div class=\"container\">\n                    <h2>D\u00e9couvrir \u00e9galement<\/h2>\n                <div class=\"links\">\n                            <a class=\"link-slider\" href=\"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/clinical\/phase-1-healthy-volunteers\/\">\n                                            <span class=\"label\">Phase I \u2013 volontaires sains<\/span>\n                                    <\/a>\n                            <a class=\"link-slider\" href=\"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/clinical\/oncology-trial-management\/\">\n                                            <span class=\"label\">Gestion d&#8217;essais en oncologie<\/span>\n                                    <\/a>\n                            <a class=\"link-slider\" href=\"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/clinical\/patient-trial-management\/\">\n                                            <span class=\"label\">Gestion des essais cliniques chez les patients<\/span>\n                                    <\/a>\n                            <a class=\"link-slider\" href=\"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/clinical\/clinical-monitoring\/\">\n                                            <span class=\"label\">Suivi clinique<\/span>\n                                    <\/a>\n                            <a class=\"link-slider\" href=\"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/clinical\/pharmacovigilance-medical-monitoring\/\">\n                                            <span class=\"label\">Pharmacovigilance et suivi m\u00e9dical<\/span>\n                                    <\/a>\n                            <a class=\"link-slider\" href=\"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/clinical\/pharmaceutical-affairs\/\">\n                                            <span class=\"label\">Services pharmaceutiques<\/span>\n                                    <\/a>\n                            <a class=\"link-slider\" href=\"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/clinical\/regulatory-affairs\/\">\n                                            <span class=\"label\">Affaires r\u00e9glementaires<\/span>\n                                    <\/a>\n                    <\/div>\n    <\/div>\n<\/section>","protected":false},"excerpt":{"rendered":"<p>Les essais d&#8217;imagerie Les techniques d&#8217;imagerie m\u00e9dicale sont utiles pour d\u00e9tecter, diagnostiquer, guider ou surveiller le traitement des maladies. Ce sont des outils essentiels dans la recherche clinique pour le d\u00e9veloppement de m\u00e9dicaments. Biotrial dispose de sp\u00e9cialistes en imagerie. Avec une \u00e9quipe d\u00e9di\u00e9e de sp\u00e9cialistes de l&#8217;imagerie, de la phase I (y compris les essais [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":7603,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-7731","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CRO | services cliniques | Essais de Phase I | Biotrial<\/title>\n<meta name=\"description\" content=\"Le groupe de d\u00e9veloppement de Biotrial agit depuis plus de trois d\u00e9cennies pour initier et soutenir divers programmes cliniques.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/services-cliniques\/essais-cliniques-specialises-de-phase-i\/\" \/>\n<meta property=\"og:locale\" content=\"fr_CA\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CRO | services cliniques | Essais de Phase I | Biotrial\" \/>\n<meta property=\"og:description\" content=\"Le groupe de d\u00e9veloppement de Biotrial agit depuis plus de trois d\u00e9cennies pour initier et soutenir divers programmes cliniques.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/services-cliniques\/essais-cliniques-specialises-de-phase-i\/\" \/>\n<meta property=\"og:site_name\" content=\"Biotrial\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-11T13:59:49+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/02\/biotrial_clincal_vaccinetrials-1024x683.jpg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/solutions-services\\\/services-cliniques\\\/essais-cliniques-specialises-de-phase-i\\\/\",\"url\":\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/solutions-services\\\/services-cliniques\\\/essais-cliniques-specialises-de-phase-i\\\/\",\"name\":\"CRO | services cliniques | Essais de Phase I | Biotrial\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/solutions-services\\\/services-cliniques\\\/essais-cliniques-specialises-de-phase-i\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/solutions-services\\\/services-cliniques\\\/essais-cliniques-specialises-de-phase-i\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.biotrial.com\\\/app\\\/uploads\\\/2023\\\/02\\\/biotrial_clincal_vaccinetrials-1024x683.jpg\",\"datePublished\":\"2023-02-07T13:31:45+00:00\",\"dateModified\":\"2024-10-11T13:59:49+00:00\",\"description\":\"Le groupe de d\u00e9veloppement de Biotrial agit depuis plus de trois d\u00e9cennies pour initier et soutenir divers programmes cliniques.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/solutions-services\\\/services-cliniques\\\/essais-cliniques-specialises-de-phase-i\\\/#breadcrumb\"},\"inLanguage\":\"fr-CA\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/solutions-services\\\/services-cliniques\\\/essais-cliniques-specialises-de-phase-i\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-CA\",\"@id\":\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/solutions-services\\\/services-cliniques\\\/essais-cliniques-specialises-de-phase-i\\\/#primaryimage\",\"url\":\"https:\\\/\\\/www.biotrial.com\\\/app\\\/uploads\\\/2023\\\/02\\\/biotrial_clincal_vaccinetrials-1024x683.jpg\",\"contentUrl\":\"https:\\\/\\\/www.biotrial.com\\\/app\\\/uploads\\\/2023\\\/02\\\/biotrial_clincal_vaccinetrials-1024x683.jpg\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/solutions-services\\\/services-cliniques\\\/essais-cliniques-specialises-de-phase-i\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Solutions &#038; 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