{"id":83,"date":"2016-03-03T14:31:18","date_gmt":"2016-03-03T13:31:18","guid":{"rendered":"http:\/\/www.aidarc.com\/?page_id=83&#038;lang=en"},"modified":"2018-01-12T16:57:30","modified_gmt":"2018-01-12T15:57:30","slug":"services","status":"publish","type":"page","link":"https:\/\/www.aidarc.com\/en\/services\/","title":{"rendered":"Services"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row][vc_column]<div class=\"dt-fancy-separator title-left h2-size style-double accent-title-color\" style=\"width: 100%;\"><div class=\"dt-fancy-title\"><span class=\"separator-holder separator-left\"><\/span>1. Regulatory Submissions<span class=\"separator-holder separator-right\"><\/span><\/div><\/div>[vc_empty_space height=&#8221;24px&#8221;]<div class=\"image-arrow\"><ul class=\"fa-ul\">\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Initial regulatory and administrative file: Ethic Committee, ANSM, CCTIRS<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Collection of the essential documents<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Review and adaptation of the informed consent forms following the French regulation<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Submissions of the protocol amendments, of the safety reports and notification of the end of study<\/li>\n<\/ul>\n<\/div>[\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space][\/vc_column][\/vc_row][vc_row type=&#8221;vc_default&#8221;][vc_column width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1474026827333{margin: 0px !important;}&#8221;]<div class=\"dt-fancy-separator title-left h2-size style-double accent-title-color\" style=\"width: 100%;\"><div class=\"dt-fancy-title\"><span class=\"separator-holder separator-left\"><\/span>2. Lead CRA<span class=\"separator-holder separator-right\"><\/span><\/div><\/div>[vc_empty_space height=&#8221;24px&#8221;]<div class=\"image-arrow\"><ul class=\"fa-ul\">\n<li>Creation\/review\/adaptation of the study documents: Study Summary, Flow chart, CRF, study drug management, monitoring plan, CRF guideline, newsletters, &#8230;<br \/>\n<i class=\"fa-li fa fa-check-square\"><\/i><\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Selection of the Investigators<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Management of the logistics of the study<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Management and negotiation of financial agreements, \u201cSingle contract\u201d<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Management of the study budget<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Organization and monitoring of the TMF<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Training and supervision of ARCs<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Review of monitoring reports, follow-up actions<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Organization and facilitation of implementation<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Coordination with the various departments involved (Project team, Safety, Data Management, Marketing, &#8230;)<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Management of the inventory of treatments \/ medical devices under study<\/li>\n<\/ul>\n<\/div>[\/vc_column][vc_column width=&#8221;1\/2&#8243;]<div class=\"dt-fancy-separator title-left h2-size style-double accent-title-color\" style=\"width: 100%;\"><div class=\"dt-fancy-title\"><span class=\"separator-holder separator-left\"><\/span>3. CRA<span class=\"separator-holder separator-right\"><\/span><\/div><\/div>[vc_empty_space height=&#8221;24px&#8221;]<div class=\"image-arrow bullet-top\"><ul class=\"fa-ul\">\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Feasibility study<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Selection of the Investigators<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Pre-study visits<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Initiation visits<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Visite de Monitoring sur site ou \u00e0 distance.<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Training of the site staff on the study procedures and on GCPs<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Monitoring visit on site or remotely<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Management of Serious Adverse Events<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Investigational Medicinal Product accountability and check of the use and storage conditions<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>On-site ISF Update \/ TMF update.<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Close out visits.<\/li>\n<\/ul>\n<\/div>[\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space][\/vc_column][\/vc_row][vc_row][vc_column]<div class=\"dt-fancy-separator title-left h2-size style-double accent-title-color\" style=\"width: 100%;\"><div class=\"dt-fancy-title\"><span class=\"separator-holder separator-left\"><\/span>4. Audits: Preparation of the Investigators sites and CAPA follow-up<span class=\"separator-holder separator-right\"><\/span><\/div><\/div>[vc_empty_space height=&#8221;24px&#8221;]<div class=\"image-arrow bullet-top\"><ul class=\"fa-ul\">\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Preparation of the Investigators sites to an audit<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Help and follow-up of the implementation of corrective and preventive actions according to the \u201cCorrective and Preventive Actions Plan\u201d (CAPA).<\/li>\n<\/ul>\n<\/div><div class=\"dt-fancy-separator title-left h2-size style-double accent-title-color\" style=\"width: 100%;\"><div class=\"dt-fancy-title\"><span class=\"separator-holder separator-left\"><\/span>5. Study-Coordinator<span class=\"separator-holder separator-right\"><\/span><\/div><\/div>[vc_empty_space][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;]<div class=\"image-arrow\"><ul class=\"fa-ul\">\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Receipt, installation and initiation of the study material<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Creation of the study procedures for the units involved in the study<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Help with patients recruitment<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Check of the patients eligibility<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Organization and planning of the patient visits, the medical examinations, the biological samples, \u2026, following the study protocol<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Update of the patients medical files<i class=\"fa-li fa fa-check-square\"><\/i><\/li>\n<\/ul>\n<\/div>[\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;]<div class=\"image-arrow\"><ul class=\"fa-ul\">\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Completion of the Case Report Form, queries resolution<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Preparation and sending of the ambient and frozen biological samples<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Management of the stock of study documents, of the study biological kits and other study material (supply and follow-up of expiry dates)<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Management of quality of life, socio-economic or pharmacoeconomic questionnaires.<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Report and follow-up of Serious Adverse Events<\/li>\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Interface between the Promotor and the site staff.<i class=\"fa-li fa fa-check-square\"><\/i><\/li>\n<\/ul>\n<\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space][\/vc_column][\/vc_row][vc_row type=&#8221;vc_default&#8221; css=&#8221;.vc_custom_1474026803907{padding: 20px !important;}&#8221;][vc_column css=&#8221;.vc_custom_1474026827333{margin: 0px !important;}&#8221;]<div class=\"dt-fancy-separator title-left h2-size style-double accent-title-color\" style=\"width: 100%;\"><div class=\"dt-fancy-title\"><span class=\"separator-holder separator-left\"><\/span>6. GCPs Training of the site staff<span class=\"separator-holder separator-right\"><\/span><\/div><\/div>[vc_empty_space height=&#8221;24px&#8221;]<div class=\"image-arrow\"><ul class=\"fa-ul\">\n<li><i class=\"fa-li fa fa-check-square\"><\/i>Training of Investigators and Study-Coordinators in Good Clinical Practice.<\/li>\n<\/ul>\n<\/div>[\/vc_column][\/vc_row][vc_row margin_top=&#8221;32&#8243;][vc_column css=&#8221;.vc_custom_1473424380225{margin-bottom: 32px !important;}&#8221;]<section class=\"shortcode-action-box box-style-table shortcode-action-bg block-style-widget fadeIn animate-element\"><div class=\"text-big\"><div class=\"text-big\">\n<h3>Aid&#8217;ARC has been providing services in Clinical Research for 20 years<\/h3>\n<\/div>\n<p><span class=\"vc_description vc_clearfix\"><\/span><\/p>\n<\/div><div class=\"shortcode-action-container action-button\"><a href=\"http:\/\/www.aidarc.com\/en\/quotation\/\" class=\"btn-shortcode dt-btn-m dt-btn light-bg-btn title-btn-color default-btn-bg-color accent-btn-bg-hover-color fadeIn animate-element animation-builder\" id=\"dt-btn-1\"><i class=\"fa fa-chevron-circle-right\"><\/i><span>ASK FOR A QUOTE<\/span><\/a><\/div><\/section>[vc_empty_space height=&#8221;50px&#8221;][\/vc_column][\/vc_row][vc_row][vc_column]<div class=\"dt-fancy-separator h2-size style-thick accent-title-color\" style=\"width: 100%;\"><div class=\"dt-fancy-title\"><span class=\"separator-holder separator-left\"><\/span>Geographical area of activity<span class=\"separator-holder separator-right\"><\/span><\/div><\/div>[vc_empty_space height=&#8221;24px&#8221;][vc_row_inner][vc_column_inner][vc_column_text css_animation=&#8221;fadeInDown&#8221;]<strong><br \/>\nOur CRAs team is located in 2 regions, in the North and South of France :<\/strong><\/p>\n<ul>\n<li><strong>North<\/strong> : in Normandy, near PARIS<\/li>\n<li>\u00a0<strong>South<\/strong> : in the South-West, near TOULOUSE<\/li>\n<\/ul>\n<p>We operate throughout France and mainly in the following cities :[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner width=&#8221;1\/3&#8243;][vc_column_text]<\/p>\n<ul>\n<li><strong>PARIS et R\u00e9gion Parisienne<\/strong><\/li>\n<li><strong>Lille<\/strong><\/li>\n<li>Rouen<\/li>\n<li>Caen<\/li>\n<li><strong>Rennes<\/strong><\/li>\n<li>Brest<\/li>\n<li><strong>Nantes<\/strong><\/li>\n<li>Angers<\/li>\n<li>Tours<\/li>\n<li>Poitiers<\/li>\n<li>Limoges<\/li>\n<li><strong>Toulouse<\/strong><\/li>\n<li>Albi<\/li>\n<li>Pau<\/li>\n<li>Tarbes<\/li>\n<li><strong>Bordeaux<\/strong><\/li>\n<li>P\u00e9rigueux<\/li>\n<li><strong>Montpellier<\/strong><\/li>\n<li>N\u00eemes<\/li>\n<li><strong>Marseille<\/strong><\/li>\n<li>Toulon<\/li>\n<li><strong>Lyon<\/strong><\/li>\n<li>Grenoble<\/li>\n<li>Nice<\/li>\n<li>Clermont-Ferrand<\/li>\n<li>Strasbourg<\/li>\n<li>Nancy<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;2\/3&#8243;][vc_single_image image=&#8221;690&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221;][\/vc_column_inner][\/vc_row_inner][vc_empty_space][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;]<div class=\"dt-fancy-separator title-left h3-size style-double accent-title-color\" style=\"width: 100%;\"><div class=\"dt-fancy-title\"><span class=\"separator-holder separator-left\"><\/span>France and Overseas<span class=\"separator-holder separator-right\"><\/span><\/div><\/div>[vc_empty_space height=&#8221;24px&#8221;][vc_column_text]<strong>Travel throughout Metropolitan France and the French overseas departments and territories<\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;]<div class=\"dt-fancy-separator title-left h3-size style-double accent-title-color\" style=\"width: 100%;\"><div class=\"dt-fancy-title\"><span class=\"separator-holder separator-left\"><\/span>International<span class=\"separator-holder separator-right\"><\/span><\/div><\/div>[vc_empty_space height=&#8221;24px&#8221;][vc_column_text]We also operate in Europe and abroad in countries such as Belgium, England, Switzerland, Spain, Germany and Australia.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_empty_space height=&#8221;24px&#8221;][\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space][\/vc_column][\/vc_row][vc_row type=&#8221;vc_default&#8221;][vc_column width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1474026827333{margin: 0px !important;}&#8221;][vc_empty_space height=&#8221;24px&#8221;][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_empty_space height=&#8221;24px&#8221;][\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space][\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space height=&#8221;24px&#8221;][vc_empty_space][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space][\/vc_column][\/vc_row][vc_row type=&#8221;vc_default&#8221; css=&#8221;.vc_custom_1474026803907{padding: 20px !important;}&#8221;][vc_column css=&#8221;.vc_custom_1474026827333{margin: 0px !important;}&#8221;][vc_empty_space height=&#8221;24px&#8221;][\/vc_column][\/vc_row][vc_row margin_top=&#8221;32&#8243;][vc_column css=&#8221;.vc_custom_1473424380225{margin-bottom: 32px !important;}&#8221;][vc_empty_space height=&#8221;50px&#8221;][\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space height=&#8221;24px&#8221;][vc_row_inner][vc_column_inner][vc_column_text css_animation=&#8221;fadeInDown&#8221;] Our CRAs team is located in 2 regions, in the North and South of France : North : in Normandy, near PARIS \u00a0South : in the South-West,&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"class_list":["post-83","page","type-page","status-publish","hentry","description-off"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Our services in Clinical Research<\/title>\n<meta name=\"description\" content=\"AidARC works on regulatory submissions, Lead CRA and CRA, on audits and as Study-Coordinator or GCPs Training of the site staff\" \/>\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.aidarc.com\/en\/services\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Our services in Clinical Research\" 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