{"id":317,"date":"2019-05-06T15:29:32","date_gmt":"2019-05-06T15:29:32","guid":{"rendered":"http:\/\/sankbio.com\/?page_id=317"},"modified":"2020-01-20T11:39:58","modified_gmt":"2020-01-20T11:39:58","slug":"study-documents","status":"publish","type":"page","link":"https:\/\/sankbio.com\/index.php\/mesmerize\/study-documents\/","title":{"rendered":"Study Documents Review"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"317\" class=\"elementor elementor-317\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5e8affb elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5e8affb\" 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-af4a3c3\" data-id=\"af4a3c3\" 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-fa6ed81 elementor-widget elementor-widget-heading\" data-id=\"fa6ed81\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\"><b>Essential Documents<\/b><\/h3>\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-7ab7000 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7ab7000\" 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-064092a\" data-id=\"064092a\" 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-1acb44c elementor-widget elementor-widget-text-editor\" data-id=\"1acb44c\" 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>As per ICH E6(R2) 8.1, Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.<\/p><p><strong>Maximum care should be considered when it comes to essential documents preparation.<\/strong> San.K.Bio Consulting\u2019s owner has been involved in writing and review of thousands of essential documents since the beginning of her career.<\/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-97cc506 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"97cc506\" 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-d056771\" data-id=\"d056771\" 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-924f71a elementor-widget elementor-widget-text-editor\" data-id=\"924f71a\" 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 can take a fresh look at your documents and bring a critical eye on:<\/strong><\/p><ul><li><strong>Protocol (and amendments)<\/strong><\/li><li><strong>Informed consent forms<\/strong><\/li><li><strong>CRF<\/strong><\/li><li><strong>Plans<\/strong><\/li><li><strong>Subjects\u2019 facing documents, questionnaires<\/strong><\/li><li><strong>Or any other document you might<\/strong>\u00a0<strong>need support<\/strong>\u00a0<strong>on<\/strong><\/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-10a6638 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"10a6638\" 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-3270f24\" data-id=\"3270f24\" 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-b28d412 elementor-widget elementor-widget-heading\" data-id=\"b28d412\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\"><b>Visit Reports<\/b><\/h3>\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-51c966a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"51c966a\" 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-81fd467\" data-id=\"81fd467\" 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-734a194 elementor-widget elementor-widget-text-editor\" data-id=\"734a194\" 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>A well-written visit report is an essential part of documenting clinical trial oversight. In addition to being required by ICH guidelines, it also tells the story of the clinical trial to the regulatory authorities, demonstrating site performance and sponsor oversight during an audit or an inspection.<\/p><p>San.K.Bio Consulting\u2019s owner has more than 14 years\u2019 experience in visit reports\u2019 review written by CRAs from worldwide. <strong>We believe reports\u2019 review is an outstanding activity requesting an independent look, together with maturity and step-back.<\/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-931a91f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"931a91f\" 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-5bf76c7\" data-id=\"5bf76c7\" 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-c53ebe1 elementor-widget elementor-widget-text-editor\" data-id=\"c53ebe1\" 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>At San.K.Bio Consulting, we will perform a thorough review of your CRAs&#8217; monitoring reports, ensuring they deliver a high quality final report, that will give an accurate and clear picture on how the clinical study is handled at the site.<\/strong><\/p><p><strong>B<\/strong><strong>ecause we believe on the importance of constructive criticism, we give advice and tips to the CRAs to improve the quality of their reports.<\/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-04a6406 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"04a6406\" 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-9b16549\" data-id=\"9b16549\" 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\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>Essential Documents As per ICH E6(R2) 8.1, Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable&hellip; <br \/> <a class=\"read-more\" href=\"https:\/\/sankbio.com\/index.php\/mesmerize\/study-documents\/\">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-317","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>Study Documents | Visit report review | France and USA<\/title>\n<meta name=\"description\" content=\"We are expert in the review of your essential study documents, as well as your CRAs\u2019 visit reports.\" \/>\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\/study-documents\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Study Documents | Visit report review | France and USA\" \/>\n<meta property=\"og:description\" content=\"We are expert in the review of your essential study documents, as well as your CRAs\u2019 visit reports.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sankbio.com\/index.php\/mesmerize\/study-documents\/\" \/>\n<meta property=\"og:site_name\" content=\"San.K.Bio Consulting | Freelance GCP Auditor | Senior CRA | France &amp; 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