{"id":7587,"date":"2023-02-07T10:52:09","date_gmt":"2023-02-07T10:52:09","guid":{"rendered":"https:\/\/www.biotrial.com?page_id=7587"},"modified":"2024-10-11T13:05:23","modified_gmt":"2024-10-11T13:05:23","slug":"gestion-des-donnees","status":"publish","type":"page","link":"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/biometrie\/gestion-des-donnees\/","title":{"rendered":"Gestion des donn\u00e9es"},"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\/biometrie\/\" class=\"link return\">Retour<\/a>\n                            <\/div>\n            <div class=\"right\">\n                                    <a class=\"anchor\" href=\"#blockServices\">\n                        <span>CDISC SDTM<\/span>\n                    <\/a>\n                                    <a class=\"anchor\" href=\"#blockResources\">\n                        <span>\u00c9quipe<\/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<section class=\"core core-group\" ><div class=\"container\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<section class=\"acf header-depth-3\" id=\"\">\n    <div class=\"container large\">\n                    <div class=\"container\">\n                <div class=\"content\">\n                                            <h1>Gestion des donn\u00e9es<\/h1>\n                                                                <p>Notre \u00e9quipe de chefs de projet, gestionnaires de donn\u00e9es, programmeurs et codeurs m\u00e9dicaux poss\u00e8de une vaste exp\u00e9rience dans la<strong> collecte, la validation et la programmation des bases de donn\u00e9es<\/strong> d&#8217;essais cliniques SAS.<\/p>\n<p>Cette expertise comprend la Capture \u00c9lectronique de Donn\u00e9es (EDC), ainsi que l\u2019int\u00e9gration de donn\u00e9es externes telles que la pharmacocin\u00e9tique (PK), les donn\u00e9es de laboratoires centralis\u00e9s, la pharmacodynamie (PD) et l\u2019imagerie.<\/p>\n<p>Durant l\u2019essai, notre \u00e9quipe v\u00e9rifie et nettoie les donn\u00e9es et les rend facilement accessibles pour le sponsor en fournissant des services, des tableaux de bord et des outils sur mesure. Ces outils permettent aux sponsors d\u2019obtenir une <strong>vision compl\u00e8te des donn\u00e9es<\/strong> et d\u2019acc\u00e9der \u00e0 des livrables tels que des listes de donn\u00e9es individuelles et des profils de patients.<\/p>\n\n                                    <\/div>\n            <\/div>\n                            <picture>\n                <source type=\"image\/webp\"\n                    srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/istock-1085389362-1060x400.webp, https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/istock-1085389362-1060x400@2x.webp 2x\">\n                <source type=\"image\/jpeg\"\n                    srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/istock-1085389362-1060x400.jpg, https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/istock-1085389362-1060x400@2x.jpg 2x\">\n                <img decoding=\"async\" src=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/istock-1085389362-1060x400.jpg\" alt=\"\"\n                    width=\"1060\" height=\"400\" loading=\"lazy\" \/>\n            <\/picture>\n            <\/div>\n<\/section>\n\n\n<p class=\"wp-block-paragraph\">Nos services de gestion des donn\u00e9es cliniques interviennent sur <strong>toutes les phases des essais cliniques<\/strong>, depuis la conception de l&#8217;\u00e9tude et le d\u00e9veloppement du protocole, jusqu&#8217;\u00e0 la collecte, la saisie, la validation, le codage et la g\u00e9n\u00e9ration de rapports des donn\u00e9es. Nous utilisons des technologies de pointe et respectons des normes r\u00e9glementaires strictes pour assurer la qualit\u00e9 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-8f761849 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:50.25%\">\n<h2 class=\"wp-block-heading\">CDISC SDTM<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">En tant que CRO, nous fournissons des donn\u00e9es compliantes au format CDISC SDTM aux sponsors depuis 2010, assurant ainsi une <strong>gestion s\u00e9curis\u00e9e et conforme de vos donn\u00e9es.<\/strong> Nous nous engageons \u00e0 respecter la conformit\u00e9 CDISC SDTM, avec le soutien d&#8217;un groupe de gouvernance actif mettant en place des processus rigoureux, et assure une formation continue de notre \u00e9quipe.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nous collaborons \u00e9galement avec les sponsors ayant leur propre impl\u00e9mentation et gouvernance CDISC, assurant ainsi une int\u00e9gration agile des donn\u00e9es provenant de diverses sources. Nous offrons une vari\u00e9t\u00e9 compl\u00e8te de livrables CDISC SDTM, comprenant notamment :<\/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:49.75%\">\n<div class=\"wp-block-columns are-vertically-aligned-top is-layout-flex wp-container-core-columns-is-layout-8f761849 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><strong>SDTM <\/strong>: Nous g\u00e9n\u00e9rons des solutions SDTM standardis\u00e9es qui seront conformes aux derni\u00e8res directives CDISC, garantissant la qualit\u00e9, la coh\u00e9rence et l\u2019accessibilit\u00e9 des donn\u00e9es pour une soumission.<\/li>\n\n\n\n<li><strong>Define.xml et documentation associ\u00e9e : <\/strong>Nous fournissons des fichiers Define.xml et les guides complets requis pour une soumission, fournissant une documentation d\u00e9taill\u00e9e sur la structure des donn\u00e9es et facilitant l\u2019examen, ainsi que la validation des donn\u00e9es.<\/li>\n\n\n\n<li><strong>Package CDISC SEND pour les projets pr\u00e9cliniques<\/strong> : Pour les \u00e9tudes pr\u00e9cliniques, nous \u00e9laborons des packages SEND complets qui regroupent de mani\u00e8re organis\u00e9e toutes les donn\u00e9es pr\u00e9cliniques pertinentes.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div>\n\n<section class=\"core core-group\" ><div class=\"container\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading has-text-align-center\" id=\"blockResources\">Notre \u00e9quipe<\/h2>\n\n\n\n<p class=\"has-text-align-center wp-block-paragraph\">Au c\u0153ur des services de gestion des donn\u00e9es d&#8217;essais cliniques de Biotrial se trouve une \u00e9quipe de professionnels hautement qualifi\u00e9s, chacun apportant son expertise pour garantir le bon d\u00e9roulement de chaque projet.<\/p>\n\n\n\n<div class=\"wp-block-columns is-style-marge-normale is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column has-bleu-marine-background-color has-background is-layout-flow wp-block-column-is-layout-flow\">\n<h4 class=\"wp-block-heading has-blanc-color has-text-color\">Chefs de projet <\/h4>\n\n\n\n<p class=\"has-blanc-color has-text-color wp-block-paragraph\">Ils endossent le r\u00f4le de chef de projet, dirigeant l&#8217;int\u00e9gralit\u00e9 du processus de gestion des donn\u00e9es de sa conception \u00e0 sa r\u00e9alisation. Ils supervisent toutes les t\u00e2ches li\u00e9es \u00e0 la pr\u00e9paration des documents et \u00e0 la programmation, veillant \u00e0 ce que tout soit conforme aux exigences r\u00e9glementaires.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column has-vert-background-color has-background is-layout-flow wp-block-column-is-layout-flow\">\n<h4 class=\"wp-block-heading has-blanc-color has-text-color\">Programmeurs SAS<\/h4>\n\n\n\n<p class=\"has-blanc-color has-text-color wp-block-paragraph\">En programmant avec pr\u00e9cision la base de donn\u00e9es SDTM, ils produisent des livrables complets tels que les profils de patients, les listes de donn\u00e9es individuelles et les fichiers requis pour une soumission tel que le define.xml. Leur expertise r\u00e9side dans la traduction des donn\u00e9es cliniques dans un format standardis\u00e9, facilitant ainsi l\u2019analyse et la production de rapports.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column has-bleu-marine-background-color has-background is-layout-flow wp-block-column-is-layout-flow\">\n<h4 class=\"wp-block-heading has-blanc-color has-text-color\">Experts de SDTM<\/h4>\n\n\n\n<p class=\"has-blanc-color has-text-color wp-block-paragraph\">Les experts en conformit\u00e9 CDISC SDTM supervisent toutes les activit\u00e9s li\u00e9es \u00e0 la base de donn\u00e9es SDTM. Cela inclut le suivi r\u00e9glementaire, la formation des membres de l\u2019\u00e9quipe, l\u2019interaction avec les homologues des sponsors et la maintenance des outils compliants au format SDTM de Biotrial. Leur objectif est de garantir que nos pratiques de gestion des donn\u00e9es respectent les normes internationales.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column has-vert-background-color has-background is-layout-flow wp-block-column-is-layout-flow\">\n<h4 class=\"wp-block-heading has-blanc-color has-text-color\">Gestionnaires de donn\u00e9es<\/h4>\n\n\n\n<p class=\"has-blanc-color has-text-color wp-block-paragraph\">Ils constituent le pilier de notre \u00e9quipe, apportant un soutien essentiel aux chefs de projet pendant l&#8217;\u00e9tude. Leur supervision assure la collecte, la saisie, la revue, la validation, le codage et la production de rapports de donn\u00e9es de haute qualit\u00e9, garantissant ainsi l&#8217;exactitude et l&#8217;int\u00e9grit\u00e9 des donn\u00e9es.<\/p>\n<\/div>\n<\/div>\n<\/div><\/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\/biometrie\/capture-electronique-donnees\/\">\n                                            <span class=\"label\">La Capture \u00c9lectronique de Donn\u00e9es (EDC)<\/span>\n                                    <\/a>\n                            <a class=\"link-slider\" href=\"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/biometrie\/biostatistique\/\">\n                                            <span class=\"label\">Biostatistique<\/span>\n                                    <\/a>\n                            <a class=\"link-slider\" href=\"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/biometrie\/redaction-medicale\/\">\n                                            <span class=\"label\">R\u00e9daction m\u00e9dicale<\/span>\n                                    <\/a>\n                            <a class=\"link-slider\" href=\"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/preclinique\/\">\n                                            <span class=\"label\">Pr\u00e9clinique<\/span>\n                                    <\/a>\n                            <a class=\"link-slider\" href=\"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/services-cliniques\/\">\n                                            <span class=\"label\">Services cliniques<\/span>\n                                    <\/a>\n                            <a class=\"link-slider\" href=\"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/corelab\/\">\n                                            <span class=\"label\">Core Lab<\/span>\n                                    <\/a>\n                            <a class=\"link-slider\" href=\"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/bioanalyse\/\">\n                                            <span class=\"label\">Bioanalyse<\/span>\n                                    <\/a>\n                    <\/div>\n    <\/div>\n<\/section>","protected":false},"excerpt":{"rendered":"<p>Nos services de gestion des donn\u00e9es cliniques interviennent sur toutes les phases des essais cliniques, depuis la conception de l&#8217;\u00e9tude et le d\u00e9veloppement du protocole, jusqu&#8217;\u00e0 la collecte, la saisie, la validation, le codage et la g\u00e9n\u00e9ration de rapports des donn\u00e9es. Nous utilisons des technologies de pointe et respectons des normes r\u00e9glementaires strictes pour assurer [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":7569,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-7587","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CRO | Services de biom\u00e9trie | Gestion des donn\u00e9es | Biotrial<\/title>\n<meta name=\"description\" content=\"D\u00e9couvrez les services de data management de Biotrial, sp\u00e9cialis\u00e9s en gestion de donn\u00e9es pour des essais cliniques pr\u00e9cis et fiables.\" \/>\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\/biometrie\/gestion-des-donnees\/\" \/>\n<meta property=\"og:locale\" content=\"fr_CA\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CRO | Services de biom\u00e9trie | Gestion des donn\u00e9es | Biotrial\" \/>\n<meta property=\"og:description\" content=\"D\u00e9couvrez les services de data management de Biotrial, sp\u00e9cialis\u00e9s en gestion de donn\u00e9es pour des essais cliniques pr\u00e9cis et fiables.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/biometrie\/gestion-des-donnees\/\" \/>\n<meta property=\"og:site_name\" content=\"Biotrial\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-11T13:05:23+00:00\" \/>\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=\"3 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\\\/biometrie\\\/gestion-des-donnees\\\/\",\"url\":\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/solutions-services\\\/biometrie\\\/gestion-des-donnees\\\/\",\"name\":\"CRO | Services de biom\u00e9trie | Gestion des donn\u00e9es | Biotrial\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/#website\"},\"datePublished\":\"2023-02-07T10:52:09+00:00\",\"dateModified\":\"2024-10-11T13:05:23+00:00\",\"description\":\"D\u00e9couvrez les services de data management de Biotrial, sp\u00e9cialis\u00e9s en gestion de donn\u00e9es pour des essais cliniques pr\u00e9cis et fiables.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/solutions-services\\\/biometrie\\\/gestion-des-donnees\\\/#breadcrumb\"},\"inLanguage\":\"fr-CA\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/solutions-services\\\/biometrie\\\/gestion-des-donnees\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/solutions-services\\\/biometrie\\\/gestion-des-donnees\\\/#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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