{"id":309,"date":"2019-05-06T14:50:14","date_gmt":"2019-05-06T14:50:14","guid":{"rendered":"http:\/\/sankbio.com\/?page_id=309"},"modified":"2020-01-20T11:57:48","modified_gmt":"2020-01-20T11:57:48","slug":"monitoring-services","status":"publish","type":"page","link":"https:\/\/sankbio.com\/index.php\/mesmerize\/monitoring-services\/","title":{"rendered":"Monitoring Services"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"309\" class=\"elementor elementor-309\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ab80042 elementor-section-content-top elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ab80042\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-1ec30e5\" data-id=\"1ec30e5\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3e0a2f1 elementor-widget elementor-widget-text-editor\" data-id=\"3e0a2f1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>With the recent issue of ICH E6(R2), <strong>the Sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical studies<\/strong>. Also, the new guideline focuses on the possibility for the Sponsor to choose on-site monitoring, a combination of on-site and centralized (off-site) monitoring, or, where justified, centralized monitoring only. The Monitoring plan is now a requirement as per GCP and should describe the monitoring strategy, the monitoring responsibilities of all the parties involved, the various monitoring methods used, and the rationale for their use.<\/p><p>The revisions to the guideline stipulate<strong> a more proactive approach to study monitoring, <\/strong>as described below:<\/p><ul><li>remote source data verification via Electronic Data Capture (EDC) software and risk-based monitoring tools;<\/li><li>more frequent remote site contact and management;<\/li><li>less frequent onsite visits, but focusing on building strong and constructive relationships with the site, performing training, promoting GCP and supporting understanding of the protocol;<\/li><li>working with a central monitoring team that is responsible for data review.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-76004c3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"76004c3\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-746f8c2\" data-id=\"746f8c2\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-912f472 elementor-widget elementor-widget-text-editor\" data-id=\"912f472\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Our CRA is highly experienced in clinical research and familiar with risk-based approach to monitoring.\u00a0<\/strong><\/p><p><strong>She has been working for more than 17 years on national and international phase II and III studies, for industry and academic sponsors, experiencing a variety of monitoring techniques.\u00a0<\/strong><\/p><p><strong>Her<\/strong> <strong>experience as a lead CRA and project manager made her understand the larger context of the monitoring effort.\u00a0<\/strong><\/p><p><strong>She has been monitoring clinical studies in various countries of the world (France, Spain, Portugal, Mexico, USA) and<\/strong> <strong>her high<\/strong> <strong>communication skills enable her to rapidly adapt to any new project.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4e8dca7 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4e8dca7\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-42eef9a\" data-id=\"42eef9a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-74802af elementor-widget elementor-widget-text-editor\" data-id=\"74802af\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>San.K.Bio Consulting\u2019s monitoring services include:<\/strong><\/p><ul><li><strong>Site management, including support with regulatory submissions<\/strong><\/li><li><strong>Feasibility<\/strong><\/li><li><strong>Site qualification visits<\/strong><\/li><li><strong>Site initiation visits<\/strong><\/li><li><strong>Site interim monitoring visits<\/strong><\/li><li><strong>Site close out visits<\/strong><\/li><li><strong>Source document review<\/strong><\/li><li><strong>Regulatory document review<\/strong><\/li><li><strong>Drug accountability<\/strong><\/li><li><strong>Report generation<\/strong><\/li><\/ul><div><strong>San.K.Bio Consulting operates in France and in the USA.<\/strong><b><br \/><\/b><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>With the recent issue of ICH E6(R2), the Sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical studies. Also, the new guideline focuses on the possibility for the Sponsor to choose on-site monitoring, a combination of on-site and centralized (off-site) monitoring, or, where justified, centralized monitoring only. The Monitoring plan is now a&hellip; <br \/> <a class=\"read-more\" href=\"https:\/\/sankbio.com\/index.php\/mesmerize\/monitoring-services\/\">Read more<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":183,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-309","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Monitoring Services | France and USA<\/title>\n<meta name=\"description\" content=\"We provide high-quality monitoring &amp; site management in France and in the USA\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sankbio.com\/index.php\/mesmerize\/monitoring-services\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Monitoring Services | France and USA\" \/>\n<meta property=\"og:description\" content=\"We provide high-quality monitoring &amp; 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