{"id":7633,"date":"2023-02-07T13:31:15","date_gmt":"2023-02-07T13:31:15","guid":{"rendered":"https:\/\/www.biotrial.com?page_id=7633"},"modified":"2024-10-11T14:03:46","modified_gmt":"2024-10-11T14:03:46","slug":"phase-i-volontaires-sains","status":"publish","type":"page","link":"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/services-cliniques\/phase-i-volontaires-sains\/","title":{"rendered":"Phase I \u2013 volontaires sains"},"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>L&#8217;EFFET DE L&#8217;ALIMENTATION (FE)<\/span>\n                    <\/a>\n                                    <a class=\"anchor\" href=\"#etude\">\n                        <span>\u00c9tudes pharmacodynamiques<\/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-inline core-heading\" ><div class=\"container\">\n<h1 class=\"wp-block-heading has-text-align-center\">Phase I \u2013 volontaires sains<\/h1>\n<\/div><\/section>\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 SAD\/MAD<\/h1>\n                                                                <p><!-- wp:paragraph --><\/p>\n<p><strong>Essais SAD\/MAD<\/strong><strong> (dose unique<\/strong> <strong>croissante \/dose multiple croissante) chez l&#8217;homme<\/strong><\/p>\n<p>Avec plus de 35 ans d&#8217;exp\u00e9rience dans la mise en place d&#8217;\u00e9tudes de<strong> premi\u00e8re administration \u00e0 l&#8217;homme<\/strong>, Biotrial dispose d&#8217;une \u00e9quipe d&#8217;experts sp\u00e9cialis\u00e9s dans la conception, la conduite et l&#8217;interpr\u00e9tation des \u00e9tudes cliniques de phase pr\u00e9coce.<\/p>\n<p>Biotrial a men\u00e9 des \u00e9tudes de phase I sur une large gamme de m\u00e9dicaments, incluant des petites mol\u00e9cules, des produits biologiques et des th\u00e9rapies g\u00e9niques, dans divers domaines th\u00e9rapeutiques tels que l&#8217;oncologie, les maladies cardiovasculaires et les troubles neurod\u00e9g\u00e9n\u00e9ratifs.<\/p>\n<p>Nos unit\u00e9s de recherche clinique de phase I, situ\u00e9es aux \u00c9tats-Unis et en France, sont strat\u00e9giquement implant\u00e9es \u00e0 proximit\u00e9 de centres hospitaliers de r\u00e9f\u00e9rence, facilitant ainsi <strong>l&#8217;acc\u00e8s rapide aux soins m\u00e9dicaux,<\/strong> aux \u00e9quipements et aux leaders d&#8217;opinion (KOLs).<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n\n                                    <\/div>\n            <\/div>\n                            <picture>\n                <source type=\"image\/webp\"\n                    srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/06\/2211023-biotrial-pdv-reportage-01-63-1060x400.webp, https:\/\/www.biotrial.com\/app\/uploads\/2023\/06\/2211023-biotrial-pdv-reportage-01-63-1060x400@2x.webp 2x\">\n                <source type=\"image\/jpeg\"\n                    srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/06\/2211023-biotrial-pdv-reportage-01-63-1060x400.jpg, https:\/\/www.biotrial.com\/app\/uploads\/2023\/06\/2211023-biotrial-pdv-reportage-01-63-1060x400@2x.jpg 2x\">\n                <img decoding=\"async\" src=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/06\/2211023-biotrial-pdv-reportage-01-63-1060x400.jpg\" alt=\"\"\n                    width=\"1060\" height=\"400\" loading=\"lazy\" \/>\n            <\/picture>\n            <\/div>\n<\/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<figure class=\"wp-block-image size-large is-style-rounded\"><picture><source srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/06\/2211023-biotrial-pdv-reportage-01-3-1024x683.webp\" type=\"image\/webp\" \/><img src=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/06\/2211023-biotrial-pdv-reportage-01-3-1024x683.jpg\" width=\"1024\"  height=\"683\" class=\"wp-image-5468\" alt=\"2211023 Biotrial Pdv Reportage 01 3\" ><\/picture><\/figure>\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 are-vertically-aligned-top 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<p>Diff\u00e9rentes \u00e9tudes  peuvent \u00eatre men\u00e9es de fa\u00e7on pr\u00e9coce, individuellement, ou dans le cadre de protocoles combin\u00e9s:<\/p>\n\n\n\n<ul id=\"block-26a1009c-4dba-410e-b30e-ecda0fc950a6\" class=\"wp-block-list\">\n<li>Escalade de dose\n<ul class=\"wp-block-list\">\n<li>Dose unique croissante (SAD)<\/li>\n\n\n\n<li>Dose multiple croissante (MAD)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div>\n\n\n\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>\u00c9valuation de l&#8217;effet de l&#8217;alimentation (FE)<\/li>\n\n\n\n<li>Interaction m\u00e9dicamenteuse (DDI) et interactions m\u00e9dicament-alcool<\/li>\n\n\n\n<li>Des protocoles complexes combin\u00e9s peuvent \u00eatre men\u00e9s dans le cadre d&#8217;un seul essai clinique, comprenant par exemple SAD-MAD +FE\/DDI\/QT\/POC\/populations sp\u00e9cifiques (\u00e2ge, sexe).<\/li>\n<\/ul>\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=\"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\/05\/2211023-biotrial-pdv-reportage-01-48-scaled-540x540-c-default.webp, https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/2211023-biotrial-pdv-reportage-01-48-scaled-540x540-c-default@2x.webp 2x\">\n                    <source type=\"image\/jpeg\"\n                        srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/2211023-biotrial-pdv-reportage-01-48-scaled-540x540-c-default.jpg, https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/2211023-biotrial-pdv-reportage-01-48-scaled-540x540-c-default@2x.jpg 2x\">\n                    <img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/2211023-biotrial-pdv-reportage-01-48-scaled-540x540-c-default.jpg\" alt=\"\"\n                        width=\"540\" height=\"540\" \/>\n                <\/picture>\n            <\/div>\n                <div class=\"right\">\n                            <h2>L&#8217;effet de l&#8217;alimentation<\/h2>\n                                        <p>Ces \u00e9tudes sont essentielles pour comprendre comment l&#8217;alimentation influence l&#8217;absorption, la distribution, le m\u00e9tabolisme et l&#8217;excr\u00e9tion des m\u00e9dicaments administr\u00e9s par voie orale. Biotrial dispose d&#8217;une \u00e9quipe de pharmacologues cliniques exp\u00e9riment\u00e9s, sp\u00e9cialis\u00e9s dans la conception, la conduite et l&#8217;interpr\u00e9tation de ces \u00e9tudes.<\/p>\n<p>Nos \u00e9tudes sur l&#8217;effet des aliments sont r\u00e9alis\u00e9es chez des volontaires sains, sous la supervision de m\u00e9decins exp\u00e9riment\u00e9s. Nous utilisons diverses m\u00e9thodes pour \u00e9valuer l&#8217;effet de l&#8217;alimentation, notamment :<\/p>\n<ul>\n<li><strong>Surveillance de la concentration plasmatique<\/strong> : Nous mesurons la concentration du produit \u00e0 l&#8217;\u00e9tude dans le sang pour suivre son absorption, sa distribution, son m\u00e9tabolisme et son excr\u00e9tion.<\/li>\n<li><strong>Excr\u00e9tion urinaire<\/strong> : Nous collectons et analysons des \u00e9chantillons d&#8217;urine pour mesurer la quantit\u00e9 de produit excr\u00e9t\u00e9e.<\/li>\n<li><strong>\u00c9tudes de m\u00e9tabolisme<\/strong> : Nous utilisons des techniques in vitro et in vivo pour \u00e9tudier comment le m\u00e9dicament est m\u00e9tabolis\u00e9 par le corps.<\/li>\n<\/ul>\n\n                    <\/div>\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\/05\/2211023-biotrial-pdv-reportage-01-56-scaled-540x540-c-default.webp, https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/2211023-biotrial-pdv-reportage-01-56-scaled-540x540-c-default@2x.webp 2x\">\n                    <source type=\"image\/jpeg\"\n                        srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/2211023-biotrial-pdv-reportage-01-56-scaled-540x540-c-default.jpg, https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/2211023-biotrial-pdv-reportage-01-56-scaled-540x540-c-default@2x.jpg 2x\">\n                    <img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/2211023-biotrial-pdv-reportage-01-56-scaled-540x540-c-default.jpg\" alt=\"\"\n                        width=\"540\" height=\"540\" \/>\n                <\/picture>\n            <\/div>\n                <div class=\"right\">\n                            <h2>\u00c9tudes sur les interactions m\u00e9dicamenteuses <\/h2>\n                                        <p><strong>R\u00e9duction du risque d&#8217;interactions m\u00e9dicamenteuses\u00a0<\/strong><\/p>\n<p>Les patients prennent souvent plusieurs m\u00e9dicaments simultan\u00e9ment, ce qui peut entra\u00eener des interactions nocives. Ces interactions peuvent notamment r\u00e9duire l&#8217;efficacit\u00e9 des m\u00e9dicaments ou augmenter leur toxicit\u00e9.<\/p>\n<p>Biotrial poss\u00e8de une vaste exp\u00e9rience dans la conception et la r\u00e9alisation d&#8217;\u00e9tudes sur les interactions m\u00e9dicamenteuses. Notre \u00e9quipe d&#8217;experts a men\u00e9 des \u00e9tudes sur une large gamme de m\u00e9dicaments, incluant des petites mol\u00e9cules, des produits biologiques et des th\u00e9rapies g\u00e9niques, dans<strong> divers domaines th\u00e9rapeutiques<\/strong> tels que l&#8217;oncologie, les maladies cardiovasculaires et les troubles neurod\u00e9g\u00e9n\u00e9ratifs.<\/p>\n<p>Nos \u00e9tudes sur les interactions m\u00e9dicamenteuses sont r\u00e9alis\u00e9es chez des volontaires sains ou des patients, conform\u00e9ment aux directives de la <strong>FDA et de l&#8217;EMA<\/strong>. Nous utilisons diverses m\u00e9thodes pour \u00e9valuer le potentiel d&#8217;interaction des m\u00e9dicaments, notamment :<\/p>\n<ul>\n<li>\u00c9tudes prospectives d&#8217;interactions m\u00e9dicamenteuses<\/li>\n<li>\u00c9tudes sur l&#8217;inhibition des enzymes P450 (CYP)<\/li>\n<li>Interactions m\u00e9dicamenteuses induites par des transporteurs<\/li>\n<li>\u00c9tudes de combinaison de m\u00e9dicaments<\/li>\n<\/ul>\n<p>Ces \u00e9tudes permettent d&#8217;identifier pr\u00e9cocement les interactions m\u00e9dicamenteuses potentielles, de d\u00e9velopper des strat\u00e9gies pour<strong> r\u00e9duire les risques d&#8217;interactions<\/strong>, et d&#8217;\u00e9valuer la toxicit\u00e9 et l&#8217;efficacit\u00e9 des m\u00e9dicaments sur des populations vari\u00e9es.<\/p>\n\n                    <\/div>\n    <\/div>\n<\/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\">\u00c9tude &#8220;preuve de concept&#8221;<strong> <\/strong>(POC)<\/h2>\n\n\n\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-01-159-1024x683.webp\" type=\"image\/webp\" \/><img src=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/05\/2211023-biotrial-pdv-reportage-01-159-1024x683.jpg\" width=\"1024\"  height=\"683\" class=\"wp-image-5220\" alt=\"Biotrial-clinical-poc-studies-reportage\" loading=\"lazy\"><\/picture><\/figure>\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 are-vertically-aligned-top 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<p>Les \u00e9tudes de validation de principe ou &#8220;preuve du concept&#8221; (POC) sont cruciales pour prendre des d\u00e9cisions rapides dans le processus de d\u00e9veloppement de m\u00e9dicaments. Les nouvelles entreprises de biotechnologie ont notamment besoin d&#8217;obtenir rapidement des informations sur l&#8217;efficacit\u00e9 potentielle de leurs produits.<\/p>\n\n\n\n<p class=\"is-style-default\">Biotrial poss\u00e8de l&#8217;expertise n\u00e9cessaire pour mener des essais cliniques POC avec des volontaires sains ainsi que des populations de patients sp\u00e9cifiques.<\/p>\n\n\n\n<p>Nos \u00e9tudes POC fournissent des informations pr\u00e9cieuses sur la toxicit\u00e9, la tol\u00e9rance et l&#8217;efficacit\u00e9 des nouveaux m\u00e9dicaments en phase de d\u00e9veloppement pr\u00e9coce. Ces informations sont essentielles pour d\u00e9cider de la poursuite ou de l&#8217;abandon du d\u00e9veloppement du produit.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\">\n<p>Nous avons men\u00e9 des \u00e9tudes POC dans divers domaines th\u00e9rapeutiques (liste non exhaustive), notamment :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Syst\u00e8me Nerveux<\/strong> <strong>Central <\/strong>(SNC) : Maladie d&#8217;Alzheimer, maladie de Parkinson, schizophr\u00e9nie, d\u00e9pression et \u00e9pilepsie.<\/li>\n\n\n\n<li><strong>Dermatologie <\/strong>: Dermatite atopique, psoriasis et acn\u00e9.<\/li>\n\n\n\n<li><strong>Troubles m\u00e9taboliques <\/strong>: Diab\u00e8te, ob\u00e9sit\u00e9 et hypercholest\u00e9rol\u00e9mie.<\/li>\n\n\n\n<li><strong>Inflammation <\/strong>: Arthrite rhumato\u00efde, asthme et colite ulc\u00e9reuse.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div>\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\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading\"><strong>Essais BA\/BE\/PK<\/strong><\/h2>\n\n\n\n<p>Les essais de biodisponibilit\u00e9 (BA) et de bio\u00e9quivalence (BE) sont essentiels pour garantir que les nouveaux m\u00e9dicaments sont s\u00fbrs et efficaces. Les \u00e9tudes de BA mesurent le taux et l&#8217;absorption d&#8217;un m\u00e9dicament \u00e0 partir d&#8217;une formulation test, tandis que les \u00e9tudes de BE comparent la BA de deux formulations diff\u00e9rentes du m\u00eame m\u00e9dicament. Les \u00e9tudes pharmacocin\u00e9tiques (PK) \u00e9valuent comment un m\u00e9dicament est <strong>absorb\u00e9, distribu\u00e9, m\u00e9tabolis\u00e9<\/strong> et excr\u00e9t\u00e9 par le corps.<\/p>\n\n\n\n<p>Avec<strong> 260 lits <\/strong>et des installations qui s&#8217;adaptent \u00e0 tout type d&#8217;\u00e9tude, notre base de volontaires, nous permet de mener efficacement ces essais. Notre personnel clinique est comp\u00e9tent pour g\u00e9rer <strong>des nombres importants d&#8217;\u00e9chantillons pharmacocin\u00e9tiques<\/strong>, tant pour les petites que pour les grandes mol\u00e9cules, ceci dans un environnement s\u00e9curis\u00e9 et contr\u00f4l\u00e9. Biotrial assure le d\u00e9marrage et l&#8217;ex\u00e9cution rapide des \u00e9tudes, avec une possibilit\u00e9 d&#8217;acc\u00e9l\u00e9rer les d\u00e9lais si n\u00e9cessaire.<\/p>\n\n\n\n<p>Nos \u00e9tudes BA, BE et PK fournissent des informations pr\u00e9cieuses pour garantir la s\u00e9curit\u00e9 et l&#8217;efficacit\u00e9 de chaque nouveau traitement.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\"><div class=\"wp-block-image is-style-rounded\">\n<figure class=\"aligncenter size-large\"><picture><source srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/07\/ps5.12-13-1-1024x683.webp\" type=\"image\/webp\" \/><img src=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/07\/ps5.12-13-1-1024x683.jpg\" width=\"1024\"  height=\"683\" class=\"wp-image-5975\" alt=\"Biotrial_clinical_trials\" loading=\"lazy\"><\/picture><\/figure>\n<\/div><\/div>\n<\/div>\n<\/div><\/div>\n\n<section class=\"core core-group\" ><div class=\"container\">\n<div id=\"etude\" class=\"wp-block-group is-content-justification-center is-nowrap is-layout-flex wp-container-core-group-is-layout-94bc23d7 wp-block-group-is-layout-flex\">\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>\u00c9tudes pharmacodynamiques (PD)<\/strong><\/h2>\n\n\n\n<p>Les services scientifiques en pharmacologie clinique que nous proposons sont vari\u00e9s. Biotrial est particuli\u00e8rement expert sur le d\u00e9veloppement clinique pr\u00e9coce et la <strong>recherche translationnelle<\/strong>. Voici quelques-unes de nos expertises : \u00e9valuations de la fonction cognitive, polysomnographie (PSG), \u00e9lectroenc\u00e9phalogramme (EEG) \u00e9veill\u00e9, acquisition, traitement et interpr\u00e9tation des signaux, analyse de l&#8217;intervalle QTc, pharmacocin\u00e9tique (PK) non compartimentale\/compartimentale, mod\u00e9lisation PK\/PD et simulations, s\u00e9lection de dose, imagerie (TEP, IRM, TDM, \u00e9chographie), h\u00e9matologie, incluant la coagulation et l&#8217;agr\u00e9gation plaquettaire. Nous proposons \u00e9galement de <strong>nombreux tests<\/strong> dans divers domaines tels que la dermatologie, l&#8217;ophtalmologie et la gyn\u00e9cologie.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center has-blanc-background-color has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:45%\">\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<h4 class=\"wp-block-heading\">Mod\u00e8les humains<\/h4>\n\n\n\n<p><strong>&nbsp; SNC :<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>crise de panique (mod\u00e8le au CCK), Trouble Anxieux G\u00e9n\u00e9ralis\u00e9 ou TAG (mod\u00e8le au CO2), troubles du sommeil\/insomnie (bruit)<\/li>\n\n\n\n<li>Troubles cognitifs (mod\u00e8le \u00e0 la Scopolamine), Schizophr\u00e9nie (mod\u00e8le \u00e0 la K\u00e9tamine)<\/li>\n\n\n\n<li>Somnolence diurne (mod\u00e8le de privation de sommeil)<\/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<p><strong>Autres<\/strong> <strong>:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Mod\u00e8les respiratoires (par exemple, toux induite par la capsa\u00efcine)<\/li>\n\n\n\n<li>Cutan\u00e9s (par exemple, mod\u00e8le \u00e0 l&#8217;histamine)<\/li>\n<\/ul>\n\n\n\n<p><strong>Douleur<\/strong> <strong>:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Aigu\u00eb (thermique, test au froid)<\/li>\n\n\n\n<li>Inflammatoire (\u00e9ryth\u00e8me induit par UV)<\/li>\n\n\n\n<li>Neuropathique (capsa\u00efcine seule ou avec UV)<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/section>\n\n<div class=\"core core-columns\" ><div class=\"container\">\n<div class=\"wp-block-columns is-style-marge-large 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 has-gris-clair-2-background-color has-background is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:100%\">\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-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading has-text-align-left\"><strong>\u00c9tudes Phamarcodynamiques<\/strong> <strong>(PD)<\/strong><\/h2>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Tests et mod\u00e8les de cognition<\/strong><\/h4>\n\n\n\n<p>Les tests et mod\u00e8les de cognition sont utilis\u00e9s pour \u00e9valuer l&#8217;impact des m\u00e9dicaments sur la fonction cognitive. Ces tests mesurent une vari\u00e9t\u00e9 de capacit\u00e9s cognitives, telles que l&#8217;attention, la m\u00e9moire et la prise de d\u00e9cision.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mesures qEEG dans les bandes de haute fr\u00e9quence <\/strong>: Les mesures qEEG \u00e9valuent l&#8217;activit\u00e9 \u00e9lectrique du cerveau dans les bandes de haute fr\u00e9quence. Ces bandes sont associ\u00e9es \u00e0 des fonctions cognitives telles que l&#8217;attention et la m\u00e9moire.<\/li>\n\n\n\n<li><strong>ERP : P300 ou SART+P300 :<\/strong> L&#8217;ERP mesure la r\u00e9ponse du cerveau \u00e0 un stimulus. La composante P300 de l&#8217;ERP est associ\u00e9e \u00e0 l&#8217;attention et \u00e0 la m\u00e9moire.<\/li>\n\n\n\n<li><strong>Tests de traitement de l&#8217;information<\/strong> : Les tests de traitement de l&#8217;information mesurent la vitesse et l&#8217;exactitude du traitement de l&#8217;information. Ces tests comprennent le DSST (test de substitution de symboles num\u00e9riques), le RVIP, le test de Stroop et celui de la t\u00e2che de Simon.<\/li>\n\n\n\n<li><strong>Tests d&#8217;attention\/vigilance<\/strong> : Les tests d&#8217;attention\/vigilance mesurent la capacit\u00e9 \u00e0 pr\u00eater attention et \u00e0 maintenir la concentration dans le temps. Ces tests comprennent le CFF, le SRT\/CRT, le DAT, le PVT, le CPT, les TMT A et B, et le DV.<\/li>\n\n\n\n<li><strong>Tests de m\u00e9moire <\/strong>: Les tests de m\u00e9moire mesurent la capacit\u00e9 \u00e0 stocker et \u00e0 r\u00e9cup\u00e9rer des informations. Ces tests comprennent le SWM, le NWM, le LMT et le N-back.<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading has-gris-clair-2-color has-text-color\">PD STUDIES<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Questionnaires neuropsychiatriques<\/strong><\/h4>\n\n\n\n<p>Les questionnaires neuropsychiatriques sont utilis\u00e9s pour \u00e9valuer l&#8217;impact des m\u00e9dicaments sur la sant\u00e9 mentale. Ces questionnaires mesurent une vari\u00e9t\u00e9 de sympt\u00f4mes, tels que la d\u00e9pression, l&#8217;anxi\u00e9t\u00e9 et la psychose.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>MINI <\/strong>(Entretien Neuropsychiatrique International Miniature) : Le MINI est un bref entretien diagnostique qui peut \u00eatre utilis\u00e9 pour \u00e9valuer divers troubles de la sant\u00e9 mentale.<\/li>\n\n\n\n<li><strong>MADRS <\/strong>(\u00c9chelle de cotation de la d\u00e9pression de Montgomery et Asberg) : Le MADRS est une \u00e9chelle qui mesure la s\u00e9v\u00e9rit\u00e9 de la d\u00e9pression.<\/li>\n\n\n\n<li><strong>C-SSRS <\/strong>(\u00c9chelle de gravit\u00e9 du risque suicidaire de Columbia) : Le C-SSRS est une \u00e9chelle qui mesure le risque suicidaire.<\/li>\n\n\n\n<li><strong>PANSS <\/strong>(\u00c9chelle d&#8217;\u00e9valuation des sympt\u00f4mes positifs et n\u00e9gatifs de la schizophr\u00e9nie) : Le PANSS est une \u00e9chelle qui mesure la s\u00e9v\u00e9rit\u00e9 des sympt\u00f4mes de la schizophr\u00e9nie.<\/li>\n\n\n\n<li><strong>BPRS <\/strong>(\u00c9chelle d&#8217;\u00e9valuation br\u00e8ve des sympt\u00f4mes psychiatriques) : Le BPRS est une \u00e9chelle qui mesure la s\u00e9v\u00e9rit\u00e9 des sympt\u00f4mes de divers troubles de la sant\u00e9 mentale.<\/li>\n\n\n\n<li><strong>STAI <\/strong>(Inventaire d&#8217;anxi\u00e9t\u00e9 \u00e9tat-trait) : Le STAI est une \u00e9chelle qui mesure la s\u00e9v\u00e9rit\u00e9 de l&#8217;anxi\u00e9t\u00e9.<\/li>\n\n\n\n<li><strong>CDR <\/strong>(\u00c9chelle d&#8217;\u00e9valuation clinique de la d\u00e9mence) : Le CDR est une \u00e9chelle qui mesure la s\u00e9v\u00e9rit\u00e9 de la d\u00e9mence.<\/li>\n\n\n\n<li><strong>NPI <\/strong>(Inventaire neuropsychiatrique) : Le NPI est une \u00e9chelle qui mesure la s\u00e9v\u00e9rit\u00e9 des sympt\u00f4mes neuropsychiatriques chez les patients atteints de d\u00e9mence.<\/li>\n<\/ul>\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\" style=\"grid-template-columns:auto 48%\"><div class=\"wp-block-media-text__content\">\n<h2 class=\"wp-block-heading\"><strong>Des capacit\u00e9s de recrutement importantes et sp\u00e9cifique<\/strong>s<\/h2>\n\n\n\n<p>Biotrial dispose d&#8217;un r\u00e9seau de centres de recrutement en Europe et aux \u00c9tats-Unis charg\u00e9s de cr\u00e9er des bases de volontaires actifs. Ces centres sont facilement accessibles via les transports en commun et les grands axes routiers, garantissant l&#8217;acc\u00e8s \u00e0 des populations diverses.<\/p>\n\n\n\n<p>Nous avons mis en place des strat\u00e9gies pour mener des recrutements g\u00e9n\u00e9riques et des campagnes publicitaires cibl\u00e9es, garantissant la s\u00e9curit\u00e9 des participants et favorisant une plus grande participation. <\/p>\n\n\n\n<p>Les centres de recrutement de Biotrial utilisent des syst\u00e8mes d\u00e9di\u00e9s pour garantir la s\u00e9curit\u00e9 des sujets et \u00e9viter les inscriptions multiples, tels que :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>S\u00e9lection des volontaires<\/strong><\/li>\n\n\n\n<li><strong>Surveillance des volontaires<\/strong><\/li>\n\n\n\n<li><strong>Signalement des \u00e9v\u00e9nements ind\u00e9sirables<\/strong><\/li>\n<\/ul>\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\/07\/ps5.12--1024x683.jpg\" alt=\"Biotrial-healthy-clinical-volunteers\" class=\"wp-image-5949 size-full\" srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/07\/ps5.12--1024x683.jpg 1024w, https:\/\/www.biotrial.com\/app\/uploads\/2023\/07\/ps5.12--300x200.jpg 300w, https:\/\/www.biotrial.com\/app\/uploads\/2023\/07\/ps5.12--768x512.jpg 768w, https:\/\/www.biotrial.com\/app\/uploads\/2023\/07\/ps5.12--1536x1024.jpg 1536w, https:\/\/www.biotrial.com\/app\/uploads\/2023\/07\/ps5.12--2048x1365.jpg 2048w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure><\/div>\n<\/div><\/section>\n\n\n<section class=\"acf grid-content\" id=\"\">\n    <div class=\"container large\">\n                    <div class=\"left\">\n                                    <h2>Valeurs ajout\u00e9es<\/h2>\n                                            <\/div>\n                            <div class=\"right\">\n                                                            <div class=\"row\">\n                                        <div class=\"block\">\n                                                    <div class=\"contain-img\">\n                                <picture>\n                                    <source type=\"image\/jpeg\"\n                                        srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/hopital.png, https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/hopital@2x.png 2x\">\n                                    <img decoding=\"async\" src=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/hopital.png\" alt=\"\"\n                                        width=\"45\" height=\"45\" loading=\"lazy\" \/>\n                                <\/picture>\n                            <\/div>\n                                                                            <h3>INSTALLATIONS DE DERNI\u00c8RE G\u00c9N\u00c9RATION<\/h3>\n                                                                            <div class=\"contain-txt\">\n                                <p>2 unit\u00e9s (260 lits), bas\u00e9es en Europe et aux \u00c9tats-Unis, situ\u00e9es \u00e0 proximit\u00e9 des structures hospitali\u00e8res environnantes.<\/p>\n\n                            <\/div>\n                                            <\/div>\n                                                                                                <div class=\"block\">\n                                                    <div class=\"contain-img\">\n                                <picture>\n                                    <source type=\"image\/jpeg\"\n                                        srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/avis-client.png, https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/avis-client@2x.png 2x\">\n                                    <img decoding=\"async\" src=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/avis-client.png\" alt=\"\"\n                                        width=\"45\" height=\"45\" loading=\"lazy\" \/>\n                                <\/picture>\n                            <\/div>\n                                                                            <h3>EXP\u00c9RIENCE<\/h3>\n                                                                            <div class=\"contain-txt\">\n                                <p>Une \u00e9quipe d\u00e9vou\u00e9e, forte de plus de trois d\u00e9cennies d&#8217;exp\u00e9rience, sp\u00e9cialis\u00e9e dans la conception et la r\u00e9alisation d&#8217;essais cliniques vari\u00e9s.<\/p>\n\n                            <\/div>\n                                            <\/div>\n                                            <\/div>\n                                                                                                    <div class=\"row\">\n                                        <div class=\"block\">\n                                                    <div class=\"contain-img\">\n                                <picture>\n                                    <source type=\"image\/jpeg\"\n                                        srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/circle.png, https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/circle@2x.png 2x\">\n                                    <img decoding=\"async\" src=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/circle.png\" alt=\"\"\n                                        width=\"45\" height=\"45\" loading=\"lazy\" \/>\n                                <\/picture>\n                            <\/div>\n                                                                            <h3>SOLUTIONS COMPLETES<\/h3>\n                                                                            <div class=\"contain-txt\">\n                                <p>Conseils scientifiques, Soumissions r\u00e9glementaires, D\u00e9veloppement de protocoles, Pharmacovigilance, Surveillance clinique et m\u00e9dicale, Laboratoire central, Bioanalyse, Statistiques, R\u00e9daction de rapports d&#8217;\u00e9tude clinique (CSR)&#8230;<\/p>\n\n                            <\/div>\n                                            <\/div>\n                                                                                                <div class=\"block\">\n                                                    <div class=\"contain-img\">\n                                <picture>\n                                    <source type=\"image\/jpeg\"\n                                        srcset=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/schedule.png, https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/schedule@2x.png 2x\">\n                                    <img decoding=\"async\" src=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/03\/schedule.png\" alt=\"\"\n                                        width=\"45\" height=\"45\" loading=\"lazy\" \/>\n                                <\/picture>\n                            <\/div>\n                                                                            <h3>QUALIT\u00c9 ET RESPECT DES D\u00c9LAIS<\/h3>\n                                                                            <div class=\"contain-txt\">\n                                <p>Nous fournissons des services de haute qualit\u00e9 tout en maintenant des d\u00e9lais de r\u00e9alisation tr\u00e8s serr\u00e9es.<\/p>\n\n                            <\/div>\n                                            <\/div>\n                                            <\/div>\n                                                                    <\/div>\n            <\/div>\n<\/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\/services-cliniques\/phase-i-volontaires-sains\/\">\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>Phase I \u2013 volontaires sains Diff\u00e9rentes \u00e9tudes peuvent \u00eatre men\u00e9es de fa\u00e7on pr\u00e9coce, individuellement, ou dans le cadre de protocoles combin\u00e9s: \u00c9tude &#8220;preuve de concept&#8221; (POC) Les \u00e9tudes de validation de principe ou &#8220;preuve du concept&#8221; (POC) sont cruciales pour prendre des d\u00e9cisions rapides dans le processus de d\u00e9veloppement de m\u00e9dicaments. Les nouvelles entreprises de [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":7603,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-7633","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 | Phase I Volontaires sains | Biotrial<\/title>\n<meta name=\"description\" content=\"Biotrial est reconnu pour son expertise dans la mise en \u0153uvre et la conduite d&#039;\u00e9tudes de premi\u00e8re administration chez l&#039;homme (FIH).\" \/>\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\/phase-i-volontaires-sains\/\" \/>\n<meta property=\"og:locale\" content=\"fr_CA\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CRO | Services cliniques | Phase I Volontaires sains | Biotrial\" \/>\n<meta property=\"og:description\" content=\"Biotrial est reconnu pour son expertise dans la mise en \u0153uvre et la conduite d&#039;\u00e9tudes de premi\u00e8re administration chez l&#039;homme (FIH).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.biotrial.com\/fr-ca\/solutions-services\/services-cliniques\/phase-i-volontaires-sains\/\" \/>\n<meta property=\"og:site_name\" content=\"Biotrial\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-11T14:03:46+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.biotrial.com\/app\/uploads\/2023\/06\/2211023-biotrial-pdv-reportage-01-3-1024x683.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=\"6 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\\\/phase-i-volontaires-sains\\\/\",\"url\":\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/solutions-services\\\/services-cliniques\\\/phase-i-volontaires-sains\\\/\",\"name\":\"CRO | Services cliniques | Phase I Volontaires sains | Biotrial\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/solutions-services\\\/services-cliniques\\\/phase-i-volontaires-sains\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/solutions-services\\\/services-cliniques\\\/phase-i-volontaires-sains\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.biotrial.com\\\/app\\\/uploads\\\/2023\\\/06\\\/2211023-biotrial-pdv-reportage-01-3-1024x683.jpg\",\"datePublished\":\"2023-02-07T13:31:15+00:00\",\"dateModified\":\"2024-10-11T14:03:46+00:00\",\"description\":\"Biotrial est reconnu pour son expertise dans la mise en \u0153uvre et la conduite d'\u00e9tudes de premi\u00e8re administration chez l'homme (FIH).\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/solutions-services\\\/services-cliniques\\\/phase-i-volontaires-sains\\\/#breadcrumb\"},\"inLanguage\":\"fr-CA\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/solutions-services\\\/services-cliniques\\\/phase-i-volontaires-sains\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-CA\",\"@id\":\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/solutions-services\\\/services-cliniques\\\/phase-i-volontaires-sains\\\/#primaryimage\",\"url\":\"https:\\\/\\\/www.biotrial.com\\\/app\\\/uploads\\\/2023\\\/06\\\/2211023-biotrial-pdv-reportage-01-3-1024x683.jpg\",\"contentUrl\":\"https:\\\/\\\/www.biotrial.com\\\/app\\\/uploads\\\/2023\\\/06\\\/2211023-biotrial-pdv-reportage-01-3-1024x683.jpg\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.biotrial.com\\\/fr-ca\\\/solutions-services\\\/services-cliniques\\\/phase-i-volontaires-sains\\\/#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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