{"id":8345,"date":"2025-06-05T11:34:42","date_gmt":"2025-06-05T03:34:42","guid":{"rendered":"https:\/\/regask.com\/?p=8345"},"modified":"2025-07-17T10:53:12","modified_gmt":"2025-07-17T02:53:12","slug":"unterstutzung-globaler-hybridversuche-vereinfacht-konform-und-skalierbar","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/powering-global-hybrid-trials-simplified-compliant-and-scalable\/","title":{"rendered":"Durchf\u00fchrung globaler hybrider klinischer Studien: Vereinfacht, kom\u2026"},"content":{"rendered":"<h4><strong>Die Herausforderung<\/strong><\/h4>\n<p class=\"p1\">Ein weltweit f\u00fchrendes Pharmaunternehmen bereitete die Skalierung hybrider klinischer Studien f\u00fcr sein Produkt \u201eFood for Special Medical Purposes\u201c (FSMP) vor. Die vielf\u00e4ltigen und sich weiterentwickelnden regionalen Vorschriften stellten jedoch eine gro\u00dfe H\u00fcrde f\u00fcr die effektive Skalierung der Studien dar.<\/p>\n<p class=\"p1\">Die regulatorischen Rahmenbedingungen f\u00fcr hybride und dezentralisierte klinische Studien (DCTs) unterscheiden sich weltweit erheblich und es gibt kein harmonisiertes Regelwerk.<\/p>\n<p class=\"p1\">Die Anforderungen an elektronische Einwilligungen, digitale Gesundheitstools, Hausbesuche, Fern\u00fcberwachung und Datenschutz unterscheiden sich je nach Rechtsraum erheblich. Die Herausforderung bestand nicht nur darin, die Studien durchzuf\u00fchren, sondern auch die geltenden Vorschriften der einzelnen L\u00e4nder zu verstehen. Dies verdeutlichte die Notwendigkeit ma\u00dfgeschneiderter regulatorischer Richtlinien f\u00fcr die lokale Umsetzung.<\/p>\n<h4 data-start=\"781\" data-end=\"933\"><\/h4>\n<h4 data-start=\"781\" data-end=\"933\"><strong data-start=\"781\" data-end=\"804\">Der RegASK-Ansatz<\/strong><\/h4>\n<p><span data-teams=\"true\">RegASK, durch die Kombination seiner <a href=\"https:\/\/regask.com\/de\/produkt\/#RegGenius:~:text=Book%20a%20demo-,RegGenius,-Your%20GenAI%20co\">KI-gesteuerte L\u00f6sung f\u00fcr regulatorische Intelligenz<\/a> brachte mit seiner umfassenden Fachkompetenz Struktur in die Komplexit\u00e4t.<\/span><\/p>\n<p>Wir lieferten ein Set von <strong>DCT-Regulierungsleitf\u00e4den<\/strong> f\u00fcr 27 strategische M\u00e4rkte. Jeder Leitfaden enthielt:<\/p>\n<ul>\n<li>Klare, validierte und umsetzbare Erkenntnisse zu lokalen DCT-Vorschriften<\/li>\n<li>L\u00e4ndervergleiche zur Beurteilung der regulatorischen Anforderungen und der Bereitschaft<\/li>\n<li>Praktische Q&amp;A-Navigation zur Unterst\u00fctzung klinischer Betriebs- und Regulierungsteams<\/li>\n<li>Kontinuierliche Updates, um die Teams auf dem Laufenden zu halten, was die sich entwickelnden regulatorischen Rahmenbedingungen angeht<\/li>\n<\/ul>\n\t<div id=\"gap-2061780390\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2061780390 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><strong>Wichtige Highlights<\/strong><\/h4>\n\t<div id=\"gap-706351747\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-706351747 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n\t<div id=\"stack-1321683435\" class=\"stack stack-row justify-start items-stretch\">\n\t\t\n<div class=\"row equal-height-row\"  id=\"row-1149234350\">\n\n\t<div id=\"col-1728921375\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner text-left dark\" style=\"background-color:rgb(10, 35, 66);\" >\n\t\t\t\n\t\t\t\n<h1>27<\/h1>\n<p>abgedeckte Gerichtsbarkeiten<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1728921375 > .col-inner {\n  padding: 10% 10% 10% 10%;\n  border-radius: 16px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1472917622\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\" style=\"background-color:#e5e8fb;\" >\n\t\t\t\n\t\t\t\n<h1>90%<\/h1>\n<p>Zeitersparnis bei der Zusammenstellung der L\u00e4ndervorschriften<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1472917622 > .col-inner {\n  padding: 10% 10% 10% 10%;\n  border-radius: 16px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-532975647\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner dark\" style=\"background-color:#0a2342;\" >\n\t\t\t\n\t\t\t\n<h1>Leichtigkeit<\/h1>\n<p>auf Daten zugreifen<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-532975647 > .col-inner {\n  padding: 10% 10% 10% 10%;\n  border-radius: 16px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n<style>\n#row-1149234350 > .col > .col-inner {\n  background-color: #0a2342;\n  border-radius: 14px;\n}\n<\/style>\n<\/div>\n\t\t\n<style>\n#stack-1321683435 > * {\n  --stack-gap: 0rem;\n}\n<\/style>\n\t<\/div>\n\t\n<a href=\"https:\/\/regask.com\/de\/kontakt\/\" class=\"button primary\" >\n\t\t<span>Erfahren Sie mehr \u00fcber den RegASK-Ansatz mit unserem Team<\/span>\n\t<\/a>\n\n\t<div id=\"gap-808236478\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-808236478 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><strong>Das Ergebnis<\/strong><\/h4>\n<p>RegASK erm\u00f6glichte eine schnellere und zuverl\u00e4ssigere Versuchsplanung und -durchf\u00fchrung durch:<\/p>\n<ul>\n<li>Erm\u00f6glicht schnellere, evidenzbasierte Entscheidungen hinsichtlich Studiendesign und Einf\u00fchrungsstrategie. Bef\u00e4higt klinische und regulatorische Teams mit aktuellen, lokalisierten Informationen.<\/li>\n<li>Zeitaufw\u00e4ndige manuelle Recherchen in mehreren L\u00e4ndern wurden eliminiert<\/li>\n<li>Unterst\u00fctzte konforme, skalierbare Implementierung hybrider klinischer Studien auf globalen M\u00e4rkten<\/li>\n<\/ul>\n<p><strong>Von regulatorischer Unsicherheit bis hin zu Wettbewerbsvorteilen sorgte RegASK f\u00fcr Klarheit, Vertrauen und Geschwindigkeit.<\/strong><\/p>\n\t<div id=\"gap-536477226\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-536477226 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"is-divider divider clearfix\" style=\"max-width:100%;height:2px;background-color:rgb(197, 202, 236);\"><\/div>\n\t<div id=\"gap-619133257\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-619133257 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>H\u00e4ufig gestellte Fragen<\/h2>\n\t<div id=\"gap-1800095083\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1800095083 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><strong>F1: Wie tr\u00e4gt RegASK dazu bei, die DCT-Konformit\u00e4t l\u00e4nder\u00fcbergreifend zu vereinfachen?<\/strong><\/h4>\n<p>RegASK vereinfacht die Einhaltung der Vorschriften f\u00fcr klinische Studien, indem es klare, validierte Einblicke in l\u00e4nderspezifische regulatorische Anforderungen bietet. Unsere von Experten verfassten Leitf\u00e4den und unsere globale Informationsplattform helfen Stakeholdern, die lokalen Regeln f\u00fcr dezentrale Komponenten wie eConsent, Telemedizin und Fern\u00fcberwachung zu verstehen. Dies erm\u00f6glicht konsistente, konforme Studienstrategien in unterschiedlichen regulatorischen Umgebungen.<\/p>\n<h4><\/h4>\n<h4><strong>Frage 2: <span data-teams=\"true\">Welche Inhalte decken die Regulatory Guidebooks ab?<\/span><\/strong><\/h4>\n<p>Die Regulatory Guidebooks von RegASK bieten l\u00e4nderspezifische Einblicke in die klinische Studienlandschaft und behandeln den Ethikkommissionsprozess, Zeitpl\u00e4ne und dezentrale Elemente wie elektronische Einwilligung, elektronische Signatur und Datenverarbeitung. Sie unterst\u00fctzen die effektive Planung und regulatorische Navigation von Studien in Zielm\u00e4rkten.<\/p>\n<h4><\/h4>\n<h4><strong>F3: Wie bleibt RegASK den sich schnell \u00e4ndernden Vorschriften immer einen Schritt voraus?<\/strong><\/h4>\n<p>RegASK bleibt den sich schnell \u00e4ndernden Vorschriften durch eine Kombination aus:<\/p>\n<p>\u2022 fortschrittliche KI-gesteuerte \u00dcberwachungstools<br \/>\n\u2022 ein globales Netzwerk von Regulierungsexperten<br \/>\n\u2022 kontinuierliche Analyse offizieller Updates und Branchentrends<\/p>\n<p>Dadurch sind wir in der Lage, validierte Erkenntnisse nahezu in Echtzeit bereitzustellen, die unseren Kunden dabei helfen, sich schnell anzupassen und die Compliance auf allen M\u00e4rkten aufrechtzuerhalten.<\/p>","protected":false},"excerpt":{"rendered":"<p>Die Herausforderung: Ein f\u00fchrendes globales Pharmaunternehmen bereitete die Ausweitung hybrider klinischer Studien f\u00fcr sein Lebensmittel f\u00fcr besondere medizinische Zwecke (FSMP) vor. Die unterschiedlichen und sich st\u00e4ndig \u00e4ndernden regionalen Vorschriften stellten jedoch eine gro\u00dfe H\u00fcrde f\u00fcr die effektive Durchf\u00fchrung der Studien dar. Die regulatorischen Rahmenbedingungen f\u00fcr hybride und dezentrale klinische Studien (DCTs) variieren weltweit erheblich, und es gibt keine einheitliche Regelung\u2026<\/p>","protected":false},"author":33,"featured_media":8358,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[17,527,18,21],"tags":[197],"class_list":["post-8345","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-study","category-united-states-regulations","category-food-and-beverage","category-pharma-and-biotech","tag-infant-formula"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>US | Decentralized Clinical Trials for FSMP | Case Study | RegASK<\/title>\n<meta name=\"description\" content=\"Learn how RegASK enabled global hybrid 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