{"id":2475,"date":"2024-06-28T10:54:59","date_gmt":"2024-06-28T08:54:59","guid":{"rendered":"http:\/\/localhost\/wordpress\/?page_id=2475"},"modified":"2025-12-11T14:48:44","modified_gmt":"2025-12-11T13:48:44","slug":"cro-services","status":"publish","type":"page","link":"https:\/\/www.clinsearch.net\/fr\/cro-services\/","title":{"rendered":"Services CRO"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"2475\" class=\"elementor elementor-2475\">\n\t\t\t\t<div class=\"elementor-element elementor-element-34ef8ca2 e-con-full e-flex e-con e-parent\" data-id=\"34ef8ca2\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-24a76989 e-con-full e-flex e-con e-child\" data-id=\"24a76989\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-5b696f8a e-con-full e-flex e-con e-child\" data-id=\"5b696f8a\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-5007e5ab e-con-full e-flex e-con e-child\" data-id=\"5007e5ab\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-134f5247 elementor-widget elementor-widget-text-editor\" data-id=\"134f5247\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container translation-block\"><span><span style=\"text-align: var(--text-align);letter-spacing: var( --e-global-typography-primary-letter-spacing )\"><span style=\"font-family: 'garamond';font-style: italic;font-size: 120%\">Nos <\/span>solutions &amp;\u00a0services<\/span><\/span><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eca09e5 raven-nav-menu-align-center raven-nav-menu-stretch raven-mobile-nav-menu-align-left elementor-widget elementor-widget-raven-nav-menu\" data-id=\"eca09e5\" data-element_type=\"widget\" data-settings=\"{&quot;submenu_icon&quot;:&quot;&lt;svg 0=\\&quot;fas fa-chevron-down\\&quot; class=\\&quot;e-font-icon-svg e-fas-chevron-down\\&quot;&gt;\\n\\t\\t\\t\\t\\t&lt;use xlink:href=\\&quot;#fas-chevron-down\\&quot;&gt;\\n\\t\\t\\t\\t\\t\\t&lt;symbol id=\\&quot;fas-chevron-down\\&quot; viewBox=\\&quot;0 0 448 512\\&quot;&gt;\\n\\t\\t\\t\\t\\t\\t\\t&lt;path d=\\&quot;M207.029 381.476L12.686 187.132c-9.373-9.373-9.373-24.569 0-33.941l22.667-22.667c9.357-9.357 24.522-9.375 33.901-.04L224 284.505l154.745-154.021c9.379-9.335 24.544-9.317 33.901.04l22.667 22.667c9.373 9.373 9.373 24.569 0 33.941L240.971 381.476c-9.373 9.372-24.569 9.372-33.942 0z\\&quot;&gt;&lt;\\\/path&gt;\\n\\t\\t\\t\\t\\t\\t&lt;\\\/symbol&gt;\\n\\t\\t\\t\\t\\t&lt;\\\/use&gt;\\n\\t\\t\\t\\t&lt;\\\/svg&gt;&quot;,&quot;full_width&quot;:&quot;stretch&quot;,&quot;mobile_layout&quot;:&quot;dropdown&quot;,&quot;submenu_space_between&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;submenu_opening_position&quot;:&quot;bottom&quot;}\" data-widget_type=\"raven-nav-menu.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<nav class=\"raven-nav-menu-main raven-nav-menu-horizontal raven-nav-menu-tablet- raven-nav-menu-mobile- raven-nav-icons-hidden-tablet raven-nav-icons-hidden-mobile\">\n\t\t\t<ul id=\"menu-eca09e5\" class=\"raven-nav-menu\"><li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-13819\"><a href=\"https:\/\/www.clinsearch.net\/fr\/early-access-programs-france\/\" class=\"raven-menu-item raven-link-item\">Programmes d'acc\u00e8s d\u00e9rogatoire<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-13821\"><a href=\"https:\/\/www.clinsearch.net\/fr\/cro-services\/\" class=\"raven-menu-item raven-link-item\">Services CRO<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-13820\"><a href=\"https:\/\/www.clinsearch.net\/fr\/electronic-data-capture-clinical-trials\/\" class=\"raven-menu-item raven-link-item\">Collecte de donn\u00e9es<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-13818\"><a href=\"https:\/\/www.clinsearch.net\/fr\/independent-committees-clinical-trials\/\" class=\"raven-menu-item raven-link-item\">Comit\u00e9s ind\u00e9pendants<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-13817\"><a href=\"https:\/\/www.clinsearch.net\/fr\/market-access-services\/\" class=\"raven-menu-item raven-link-item\">Acc\u00e8s au march\u00e9 &amp; HEOR<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-13816\"><a href=\"https:\/\/www.clinsearch.net\/fr\/medicine-acceptability\/\" class=\"raven-menu-item raven-link-item\">Acceptabilit\u00e9 des m\u00e9dicaments<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-13815\"><a href=\"https:\/\/www.clinsearch.net\/fr\/clinical-trial-quality-assurance\/\" class=\"raven-menu-item raven-link-item\">Assurance qualit\u00e9<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-13814\"><a href=\"https:\/\/www.clinsearch.net\/fr\/clinical-trial-safety-reporting\/\" class=\"raven-menu-item raven-link-item\">Vigilance<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-13822\"><a href=\"https:\/\/www.clinsearch.net\/fr\/clinical-trial-statistics-medical-writing\/\" class=\"raven-menu-item raven-link-item\">R\u00e9daction m\u00e9dicale &amp; valorisation des donn\u00e9es<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-14359\"><a href=\"https:\/\/www.clinsearch.net\/fr\/medtech-certification-support\/\" class=\"raven-menu-item raven-link-item\">MedTech certification support<\/a><\/li>\n<\/ul>\t\t<\/nav>\n\n\t\t<div class=\"raven-nav-menu-toggle\">\n\n\t\t\t\t\t\t<div class=\"raven-nav-menu-toggle-button\">\n\t\t\t\t\t\t\t\t<span class=\"fa fa-bars\"><\/span>\n\t\t\t\t\t\t\t\t<\/div>\n\n\t\t<\/div>\n\t\t<nav class=\"raven-nav-icons-hidden-tablet raven-nav-icons-hidden-mobile raven-nav-menu-mobile raven-nav-menu-dropdown\">\n\t\t\t\t\t\t\t\t\t<div class=\"raven-container\">\n\t\t\t\t<ul id=\"menu-mobile-eca09e5\" class=\"raven-nav-menu\"><li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-13819\"><a href=\"https:\/\/www.clinsearch.net\/fr\/early-access-programs-france\/\" class=\"raven-menu-item raven-link-item\">Programmes d'acc\u00e8s d\u00e9rogatoire<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-13821\"><a href=\"https:\/\/www.clinsearch.net\/fr\/cro-services\/\" class=\"raven-menu-item raven-link-item\">Services CRO<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-13820\"><a href=\"https:\/\/www.clinsearch.net\/fr\/electronic-data-capture-clinical-trials\/\" class=\"raven-menu-item raven-link-item\">Collecte de donn\u00e9es<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-13818\"><a href=\"https:\/\/www.clinsearch.net\/fr\/independent-committees-clinical-trials\/\" class=\"raven-menu-item raven-link-item\">Comit\u00e9s ind\u00e9pendants<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-13817\"><a href=\"https:\/\/www.clinsearch.net\/fr\/market-access-services\/\" class=\"raven-menu-item raven-link-item\">Acc\u00e8s au march\u00e9 &amp; HEOR<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-13816\"><a href=\"https:\/\/www.clinsearch.net\/fr\/medicine-acceptability\/\" class=\"raven-menu-item raven-link-item\">Acceptabilit\u00e9 des m\u00e9dicaments<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-13815\"><a href=\"https:\/\/www.clinsearch.net\/fr\/clinical-trial-quality-assurance\/\" class=\"raven-menu-item raven-link-item\">Assurance qualit\u00e9<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-13814\"><a href=\"https:\/\/www.clinsearch.net\/fr\/clinical-trial-safety-reporting\/\" class=\"raven-menu-item raven-link-item\">Vigilance<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-13822\"><a href=\"https:\/\/www.clinsearch.net\/fr\/clinical-trial-statistics-medical-writing\/\" class=\"raven-menu-item raven-link-item\">R\u00e9daction m\u00e9dicale &amp; valorisation des donn\u00e9es<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-14359\"><a href=\"https:\/\/www.clinsearch.net\/fr\/medtech-certification-support\/\" class=\"raven-menu-item raven-link-item\">MedTech certification support<\/a><\/li>\n<\/ul>\t\t\t<\/div>\n\t\t<\/nav>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c73e80c elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"c73e80c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">ClinSearch est votre partenaire de confiance pour la r\u00e9ussite de vos essais cliniques en Europe. Nous mettons \u00e0 votre service une expertise reconnue qui repose sur trois piliers essentiels\u202f: une <b><b>gestion de projet<\/b><\/b> adaptative, pens\u00e9e pour r\u00e9pondre aux besoins sp\u00e9cifiques des promoteurs, des  <b><b>soumissions r\u00e9glementaires<\/b> <\/b> avec un taux de r\u00e9ussite exceptionnel de 99\u202f%\u202fet des  <b><b>activit\u00e9s de monitoring multilingues<\/b> <\/b> men\u00e9es par des ARC hautement qualifi\u00e9s. Chacun de ces services est pens\u00e9 pour garantir les plus hauts standards de qualit\u00e9, de conformit\u00e9 et d\u2019efficacit\u00e9. <br> <br>Parcourez cette page pour d\u00e9couvrir comment ces trois domaines cl\u00e9s de nos op\u00e9rations cliniques peuvent soutenir votre \u00e9tude, de son lancement \u00e0 sa r\u00e9ussite. <br>  <br> <\/br><\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2bdafcdd e-con-full e-flex e-con e-child\" data-id=\"2bdafcdd\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1953f685 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"1953f685\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Gestion de projet<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-467a87f3 e-con-full e-flex e-con e-child\" data-id=\"467a87f3\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-61b855ed elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"61b855ed\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Reposant sur les meilleures normes de l'industrie, le d\u00e9partement des op\u00e9rations cliniques constitue traditionnellement l'\u00e9pine dorsale de nos services. Les chefs de projet poss\u00e8dent une \u00e9ducation universitaire avanc\u00e9e (MS\/PhD\/PharmD) et une formation approfondie en gestion d'\u00e9quipe, en gestion de projet et en outils num\u00e9riques. Ils b\u00e9n\u00e9ficient d'un d\u00e9veloppement professionnel continu, renforc\u00e9 par le mentorat et le partage des connaissances.<br><br>En fonction des besoins sp\u00e9cifiques des Promoteurs, nous proposons un mod\u00e8le de gestion de projet adaptable, allant d\u2019une implication minimale (o\u00f9 le Promoteur assure un suivi \u00e9troit de l\u2019\u00e9tude) \u00e0 une externalisation compl\u00e8te, dans laquelle ClinSearch prend en charge l\u2019int\u00e9gralit\u00e9 des activit\u00e9s de l\u2019\u00e9tude, de son lancement \u00e0 sa cl\u00f4ture.\nLe mod\u00e8le de gestion est d\u00e9fini au d\u00e9marrage du projet et peut \u00eatre ajust\u00e9 \u00e0 tout moment, selon les souhaits du Promoteur et en fonction de l\u2019avancement de l\u2019\u00e9tude. Notre recommandation initiale repose sur une analyse comparative (benchmarking) de l\u2019\u00e9tude par rapport \u00e0 des projets similaires.<br><br>Afin de garantir la continuit\u00e9 du service, chaque projet est confi\u00e9 \u00e0 un bin\u00f4me compos\u00e9 d\u2019un Chef de Projet principal et d\u2019un Chef de Projet adjoint. Le d\u00e9partement est dirig\u00e9 par l\u2019une de nos collaboratrices les plus exp\u00e9riment\u00e9es, <b>C\u00e9cile Train<\/b>.<br><br \/><br><br \/>\n<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-60d87a5b e-con-full e-flex e-con e-child\" data-id=\"60d87a5b\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-1521e3cd e-con-full e-flex e-con e-child\" data-id=\"1521e3cd\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-414e75d8 e-flex e-con-boxed e-con e-child\" data-id=\"414e75d8\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-308d3428 e-con-full e-flex e-con e-child\" data-id=\"308d3428\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-24dc71b elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"24dc71b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Nos solutions<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-212eb9ea elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"212eb9ea\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Pr\u00e9paration des documents d'\u00e9tude<br>\nFormation d'\u00e9quipe<br>\nGestion des sites et des ressources<br>\nGestion du comit\u00e9 CEC et Core Lab<br>\nR\u00e9solution des probl\u00e8mes<br>\nRapport au Promoteur<br>\nGestion budg\u00e9taire<br>\nGestion du TMF<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-27a70064 e-con-full e-flex e-con e-child\" data-id=\"27a70064\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-60856701 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"60856701\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Ressources<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-31171a5c elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"31171a5c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Directrice senior des op\u00e9rations cliniques<br>Directeur adjoint des op\u00e9rations globales<br>Chefs de projet<br>Chefs de projet adjoints<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-57099975 e-con-full e-flex e-con e-child\" data-id=\"57099975\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-51d8424e elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"51d8424e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Activit\u00e9s<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-57d83918 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"57d83918\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default translation-block\">Gestion de projet<br>Gestion du budget<br>Gestion des ARC<br>Reporting<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4089978 e-con-full e-flex e-con e-child\" data-id=\"4089978\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-380262f3 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"380262f3\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Standards<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4b4aab1f elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"4b4aab1f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-data-monitoring-committees_en.pdf\" style=\"color:#0077c8\">Directive de l'EMA sur les comit\u00e9s de surveillance des donn\u00e9es (Data Monitoring Committees)<\/a><a><b><\/b><\/a><br><a href=\"https:\/\/iris.who.int\/bitstream\/handle\/10665\/69171\/TDR_GEN_Guidelines_05.1_eng.pdf?sequence=1&amp;isAllowed=y\" style=\"color:#0077c8\">Directives op\u00e9rationnelles de l\u2019OMS pour la mise en place et le fonctionnement des comit\u00e9s ind\u00e9pendants de surveillance des donn\u00e9es et de la s\u00e9curit\u00e9 (DSMB)<\/a><br><a href=\"https:\/\/www.fda.gov\/media\/75398\/download\" style=\"color:#0077c8\">FDA's Establishment and Operation of Clinical Trial Data Monitoring Committees - Guidance for Clinical Trial Sponsors<\/a><br><a href=\"https:\/\/www.fda.gov\/files\/drugs\/published\/Clinical-Trial-Imaging-Endpoint-Process-Standards-Guidance-for-Industry.pdf\" style=\"color:#0077c8\">Directives de la FDA sur les normes de processus des crit\u00e8res d\u2019\u00e9valuation par imagerie dans les essais cliniques \u00e0 l\u2019intention de l\u2019industrie<\/a><\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bda013a e-con-full e-flex e-con e-parent\" data-id=\"bda013a\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-cc75b85 e-con-full e-flex e-con e-child\" data-id=\"cc75b85\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-7171d00 e-con-full e-flex e-con e-child\" data-id=\"7171d00\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-dbbd7ec e-con-full e-flex e-con e-child\" data-id=\"dbbd7ec\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-34b270b e-con-full e-flex e-con e-child\" data-id=\"34b270b\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-53c10c5 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"53c10c5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Soumissions r\u00e9glementaires<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-10670ae e-con-full e-flex e-con e-child\" data-id=\"10670ae\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d5da892 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"d5da892\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Avec deux experts <b>d\u00e9di\u00e9s exclusivement aux processus r\u00e9glementaires<\/b>, nous soumettons plus de 50 \u00e9tudes par an dans toute l'Europe, avec un taux de r\u00e9ussite de <b>99% sur les 5 derni\u00e8res ann\u00e9es<\/b>. Avant le d\u00e9marrage, nos experts peuvent apporter des conseils sur les pratiques r\u00e9glementaires propres \u00e0 chaque pays, ou accompagner les Promoteurs dans les \u00e9valuations de faisabilit\u00e9 des pays ou des sites.\nNotre objectif est d\u2019offrir une vision r\u00e9aliste des d\u00e9lais d\u2019approbation et des \u00e9ventuels retards.<br><br>Le processus r\u00e9glementaire est g\u00e9r\u00e9 par notre Directrice des Affaires R\u00e9glementaires, en collaboration avec les ARC internationaux ou les experts locaux, qui valident la conformit\u00e9 des traductions des documents de l\u2019\u00e9tude et les adaptent aux exigences locales. Dans le cadre du processus de soumission aux comit\u00e9s d'\u00e9thique (CE) et autorit\u00e9s comp\u00e9tentes (AC), nous assurons le suivi ainsi qu\u2019une s\u00e9rie de questions-r\u00e9ponses.<br><br>Le d\u00e9partement peut \u00e9galement r\u00e9aliser tous les contr\u00f4les n\u00e9cessaires \u00e0 la protection des donn\u00e9es personnelles conform\u00e9ment au RGPD, ou effectuer un audit si n\u00e9cessaire. \u00c0 ce jour, une Analyse d\u2019Impact relative \u00e0 la Protection des Donn\u00e9es (PIA, Privacy Impact Assessment) est exig\u00e9e uniquement en France, mais d\u2019autres pays europ\u00e9ens pourraient suivre cette tendance.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-194b11b e-con-full e-flex e-con e-child\" data-id=\"194b11b\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-a33c34d e-con-full e-flex e-con e-child\" data-id=\"a33c34d\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-3fe4590 e-flex e-con-boxed e-con e-child\" data-id=\"3fe4590\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-98036e0 e-con-full e-flex e-con e-child\" data-id=\"98036e0\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a8c0501 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"a8c0501\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Nos solutions<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2fd4c23 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"2fd4c23\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Cartographie r\u00e9glementaire<br>\nContribution r\u00e9glementaire au protocole<br>\nAdaptation r\u00e9glementaire des documents d'\u00e9tude<br>\nPr\u00e9paration de dossiers pour toute l'Europe<br>\nSoumission aux CE et aux AC<br>\nN\u00e9gociations avec les autorit\u00e9s<br>\nPIA et activit\u00e9s li\u00e9es \u00e0 la protection des donn\u00e9es<br>\nSoumission des amendements<br>\nRapports de s\u00e9curit\u00e9<br>\nNotifications de cl\u00f4ture<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-54cd90c e-con-full e-flex e-con e-child\" data-id=\"54cd90c\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-62d34e5 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"62d34e5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Ressources<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-56d83ec elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"56d83ec\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Directrice des affaires r\u00e9glementaires<br>Chef de projet affaires r\u00e9glementaires<br>DPO\n<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-656e3ca e-con-full e-flex e-con e-child\" data-id=\"656e3ca\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bca8191 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"bca8191\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Activit\u00e9s<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a17d02f elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"a17d02f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default translation-block\">Faisabilit\u00e9 r\u00e9glementaire<br>Soumission des dossiers de base et des modifications aux AC et aux CE<br>Communication avec les AC et les CE<br>\u00c9valuations de la protection des donn\u00e9es<br>\u00c9valuation des facteurs relatifs \u00e0 la vie priv\u00e9e<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bfa6d92 e-con-full e-flex e-con e-child\" data-id=\"bfa6d92\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7707dc8 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"7707dc8\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Standards<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-484cb30 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"484cb30\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/www.iso.org\/standard\/71690.html\" style=\"color:#0077c8\">ISO 14155:2020<\/a><br><a href=\"https:\/\/www.iso.org\/standard\/62085.html\" style=\"color:#0077c8\">ISO 9001:2015<\/a>\n<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-88b4b72 e-con-full e-flex e-con e-child\" data-id=\"88b4b72\" data-element_type=\"container\">\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-571e0f0 e-con-full e-flex e-con e-parent\" data-id=\"571e0f0\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-1383268 e-con-full e-flex e-con e-child\" data-id=\"1383268\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-5693e42 e-con-full e-flex e-con e-child\" data-id=\"5693e42\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-7356126 e-con-full e-flex e-con e-child\" data-id=\"7356126\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-a2ba203 e-con-full e-flex e-con e-child\" data-id=\"a2ba203\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-be26b2e elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"be26b2e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Activit\u00e9s de monitoring<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-19cca60 e-con-full e-flex e-con e-child\" data-id=\"19cca60\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-68ca159 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"68ca159\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Nos moniteurs multilingues sont rigoureusement s\u00e9lectionn\u00e9s et form\u00e9s pour r\u00e9pondre aux objectifs d'un excellent service de suivi et de collecte de donn\u00e9es.<br><br>Chez ClinSearch, le monitoring est toujours assur\u00e9 par des membres permanents du personnel poss\u00e9dant les qualifications ou la formation appropri\u00e9es en tant qu\u2019attach\u00e9 de recherche clinique (ARC), et \u00e9tant capables de communiquer couramment dans les langues des sites s\u00e9lectionn\u00e9s pour chaque \u00e9tude. Notre \u00e9quipe comprend des experts ma\u00eetrisant le <b>fran\u00e7ais, l\u2019anglais, l\u2019allemand, le n\u00e9erlandais, l\u2019espagnol, l\u2019italien,  le grec, le chinois, l\u2019arabe, le polonais, le roumain <\/b>.<br><br>Les ARC sont soigneusement s\u00e9lectionn\u00e9s en fonction des exigences sp\u00e9cifiques de chaque \u00e9tude et sont form\u00e9s minutieusement aux sp\u00e9cificit\u00e9s du protocole et du produit d'investigation.<br>\n<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-00cee2e e-con-full e-flex e-con e-child\" data-id=\"00cee2e\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-b9687ba e-con-full e-flex e-con e-child\" data-id=\"b9687ba\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-ca31b4e e-flex e-con-boxed e-con e-child\" data-id=\"ca31b4e\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-e3fb7f2 e-con-full e-flex e-con e-child\" data-id=\"e3fb7f2\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-79ba8ea elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"79ba8ea\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Nos solutions<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ed835ae elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"ed835ae\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Visites d'initiation<br>\nVisites de contr\u00f4le de routine \u2013 \u00e0 distance et sur site<br>\nVisites de cl\u00f4ture<br>\nCollecte de donn\u00e9es<br>\nAssistance sur site pour le recrutement des patients<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-490e568 e-con-full e-flex e-con e-child\" data-id=\"490e568\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-409effd elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"409effd\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Ressources<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d6c1e5b elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"d6c1e5b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">ARC<br>ARC Internationaux<br>Responsables de la collecte des donn\u00e9es<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-08fcdd3 e-con-full e-flex e-con e-child\" data-id=\"08fcdd3\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1555af9 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"1555af9\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Activit\u00e9s<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b5c3235 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"b5c3235\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Faisabilit\u00e9 et s\u00e9lection du site<br>Visites de monitoring<br>Collecte de donn\u00e9es<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bd62e0b e-con-full e-flex e-con e-child\" data-id=\"bd62e0b\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-93b14ef elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"93b14ef\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Standards<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9f6fb96 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"9f6fb96\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default translation-block\"><a class=\"hvr-sweep-to bottom blue\" href=\"https:\/\/www.ema.europa.eu\/en\/ich-e6-r2-good-clinical-practice\" target=\"_blank\" rel=\"noopener\">Bonnes pratiques cliniques ICH E6<\/a><br><a class=\"hvr-sweep-to-bottom blue\" href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/1800677\" target=\"_blank\" rel=\"noopener\">Bonnes pratiques \u00e9pid\u00e9miologiques<\/a><\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e48d756 e-con-full e-flex e-con e-child\" data-id=\"e48d756\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c2f2a26 elementor-widget elementor-widget-heading\" data-id=\"c2f2a26\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\"><div style=\"margin-top: 1.2em;padding: 1em;background-color: #f0f8ff;border-left: 4px solid #0077c8;line-height: 1.4\">\n  <b>Besoin d\u2019un partenaire fiable pour vos projets ?<\/b><br>\n  Nous sommes l\u00e0 pour vous conseiller et vous soutenir. \n  <a href=\"https:\/\/www.clinsearch.net\/fr\/contact\/\" style=\"color:#0077c8;font-weight:bold\">Contactez-nous<\/a>.\n<\/div><\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Our brands &#038;\u00a0services Early Access Programs CRO Services Data Collection Independent Committees Market Access &#038; HEOR Medicine Acceptability Quality Assurance Safety Reporting Medical Writing &amp; Data Valorization MedTech Certification Support Early Access Programs CRO Services Data Collection Independent Committees Market Access &#038; HEOR Medicine Acceptability Quality Assurance Safety Reporting Medical Writing &amp; Data Valorization MedTech [&hellip;]<\/p>","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"full-width.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-2475","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>CRO Services - ClinSearch<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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