{"id":3397,"date":"2025-10-06T11:06:34","date_gmt":"2025-10-06T09:06:34","guid":{"rendered":"https:\/\/fgk-group.com\/?post_type=services-fgk-cro&#038;p=3397"},"modified":"2026-05-08T12:39:28","modified_gmt":"2026-05-08T10:39:28","slug":"qualitaetssicherung","status":"publish","type":"services-fgk-cro","link":"https:\/\/fgk-group.com\/de\/fgk-cro\/dienstleistungen\/qualitaetssicherung\/","title":{"rendered":"Qualit\u00e4tssicherung"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"3397\" class=\"elementor elementor-3397 elementor-440\" data-elementor-post-type=\"services-fgk-cro\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3a8fd43 e-flex e-con-boxed e-con e-parent\" data-id=\"3a8fd43\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c5245df elementor-widget elementor-widget-heading\" data-id=\"c5245df\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Qualit\u00e4t bedeutet f\u00fcr uns Patientenschutz<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-be09168 elementor-widget elementor-widget-text-editor\" data-id=\"be09168\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>FGK verf\u00fcgt \u00fcber ein Qualit\u00e4tsmanagementsystem, das seinesgleichen sucht. Wir erf\u00fcllen die GCP-ICH-Richtlinien, geltende beh\u00f6rdliche Anforderungen und SOPs und sind besonders stolz auf die von uns entwickelten Struktur zur Qualit\u00e4tssicherung und die von uns gelebte Qualit\u00e4tskultur.<\/p><p>Nichtsdestotrotz unternehmen wir weiterhin erhebliche Anstrengungen, um interne Prozesse zu pr\u00fcfen und zu verbessern, obwohl wir mehrere zufriedenstellende Inspektionen durch Aufsichtsbeh\u00f6rden bestanden haben.<\/p><p>Strenge Qualit\u00e4tskontrollen gehen Hand in Hand mit der FGK-Philosophie, solide Ergebnisse zu liefern. Vor allem aber dienen sie dem Schutz der Patienten oder gesunden Probanden in Ihrer klinischen Studie. Ganz nebenbei sch\u00fctzt dies auch Sie als Studiensponsor.<\/p><p>Neben der hausinternen Qualit\u00e4ts\u00fcberwachung f\u00fchrt unsere QS-Abteilung auch Audits an Pr\u00fcfzentren, Prozessen und Systemen durch.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-38f39e1 e-con-full e-flex e-con e-child\" data-id=\"38f39e1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-bf21a9d e-con-full e-flex e-con e-child\" data-id=\"bf21a9d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-352b074 e-con-full e-flex e-con e-child\" data-id=\"352b074\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f589e7d elementor-widget elementor-widget-heading\" data-id=\"f589e7d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Gautier Sobczak, My-Data-TRUST<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6df0095 elementor-widget elementor-widget-heading\" data-id=\"6df0095\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Co-Founder &amp; Chief Business Officer<\/p>\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-095985e e-con-full e-flex e-con e-child\" data-id=\"095985e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-cf196bd e-con-full e-flex e-con e-child\" data-id=\"cf196bd\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-54c4012 elementor-widget elementor-widget-image\" data-id=\"54c4012\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"690\" height=\"690\" src=\"https:\/\/fgk-group.com\/wp-content\/uploads\/2025\/08\/quotes_fgk.png\" class=\"attachment-large size-large wp-image-6105\" alt=\"\" srcset=\"https:\/\/fgk-group.com\/wp-content\/uploads\/2025\/08\/quotes_fgk.png 690w, https:\/\/fgk-group.com\/wp-content\/uploads\/2025\/08\/quotes_fgk-300x300.png 300w, https:\/\/fgk-group.com\/wp-content\/uploads\/2025\/08\/quotes_fgk-150x150.png 150w\" sizes=\"(max-width: 690px) 100vw, 690px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a2afc47 e-con-full e-flex e-con e-child\" data-id=\"a2afc47\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-aab0ba6 elementor-widget elementor-widget-text-editor\" data-id=\"aab0ba6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><em>FGK ist ein langj\u00e4hriger und bew\u00e4hrter Partner, der schon fr\u00fch die entscheidende Bedeutung des Datenschutzes in der klinischen Forschung erkannt hat. Wir arbeiten seit vielen Jahren zusammen und verbinden die fundierte klinische Expertise von FGK mit dem Datenschutz-Know-how von <strong><a href=\"https:\/\/www.mydata-trust.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">MDT<\/a><\/strong>, um Sponsoren dabei zu unterst\u00fctzen, ihre Effizienz zu steigern, die Einhaltung gesetzlicher Vorschriften sicherzustellen und Vertrauen in die erhobenen Daten aufzubauen. Das im Laufe der Zeit gewachsene Vertrauen erm\u00f6glicht auf beiden Seiten schnelle und qualitativ hochwertige Ergebnisse, und wir freuen uns darauf, diese erfolgreiche Partnerschaft fortzusetzen!\u00a0<\/em><\/p>\t\t\t\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 class=\"elementor-element elementor-element-b23266b elementor-widget elementor-widget-heading\" data-id=\"b23266b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Was wir in der Abteilung Qualit\u00e4tssicherung tun<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-daf3fc9 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"daf3fc9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Wir<b> halten<\/b> <b>uns<\/b> an GCP- und ICH-Leitlinien, SOPs und gesetzliche Anforderungen<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Wir <b>f\u00fchren<\/b> Audits an Pr\u00fcfzentren, Datenbankaudits, Systemaudits und Vendor-Bewertungen <b>durch<\/b>.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Wir <b>auditieren<\/b> auch uns selbst, um die Einhaltung der Normen und des internen Qualit\u00e4tssystems nachzuweisen.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Wir <b>verbessern<\/b> unsere Prozesse <b>kontinuierlich<\/b> durch Korrektur- und Pr\u00e4ventivma\u00dfnahmen.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Wir <b>f\u00fchren<\/b> angemessene \u00c4nderungen am Qualit\u00e4tssystem und unseren SOPs <b>durch<\/b>.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\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","protected":false},"parent":0,"menu_order":0,"template":"","class_list":["post-3397","services-fgk-cro","type-services-fgk-cro","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Qualit\u00e4tssicherung - FGK Group<\/title>\n<meta name=\"description\" content=\"Wir liefern Quality Assurance in Clinical Trials! 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