{"id":115,"date":"2018-05-14T15:44:16","date_gmt":"2018-05-14T13:44:16","guid":{"rendered":"http:\/\/exalon.webseiten.cc\/?page_id=115"},"modified":"2019-01-31T17:35:01","modified_gmt":"2019-01-31T16:35:01","slug":"ectd-readiness","status":"publish","type":"page","link":"https:\/\/exalon.com\/de\/ectd-services\/ectd-readiness\/","title":{"rendered":"eCTD Readiness"},"content":{"rendered":"<p>Die Erstellung von korrekt formatierter Quelldokumentation f\u00fcr Einreichungen im eCTD (oder NeeS) Format ist unter Umst\u00e4nden aufwendiger als die Erstellung des elektronischen Dossiers selbst. Um die immer strikter kontrollierte Einhaltung formaler Kriterien zu garantieren, m\u00fcssen neben funktionalen Anforderungen an die Navigationshilfen (Hyperlinks, Bookmarks) zahlreiche spezielle Einstellungen im PDF-Format ber\u00fccksichtigt werden.<\/p>\n<p>Exalon unterst\u00fctzt Sie dabei, Ihre Dokumente fit f\u00fcrs eCTD zu machen. Neben der Beratung im Rahmen unseres &#8222;eCTD Readiness Assessments&#8220; bieten wir Ihnen die \u00dcbernahme l\u00e4stiger Formatierungsarbeiten an:<\/p>\n<h4>eCTD Readiness Assessment:<\/h4>\n<ul>\n<li>\u00dcberpr\u00fcfung Ihrer regulatorischen Dokumente auf Einhaltung formaler und technischer Kriterien zur elektronischen Einreichung<\/li>\n<li>Beratung und Bereitstellung von Dokumentvorlagen und &#8222;Style Guides&#8220;<\/li>\n<li>Beratung bzgl optimierter DMS und Publishing Prozesse<\/li>\n<li>Dokumenten-Verarbeitung und Report Publishing<\/li>\n<\/ul>\n<h4>Publishing komplexer und zusammengesetzter Berichte (z.B. klinische Bericht nach ICH E3)<\/h4>\n<ul>\n<li>Bookmarking und Hyperlinking von PDF Dokumenten, inklusive Bookmarking von CRFs nach Domain und Visit f\u00fcr FDA Einreichungen<\/li>\n<li>Scannen von Papierdokumenten inklusive Texterkennung in allen Masst\u00e4ben<\/li>\n<li>Formatierung von MS Word Dokumenten<\/li>\n<li>PDF Rendition<\/li>\n<li>Erstellung von XML basierter Produkt Information f\u00fcr SPL (U.S. eCTDs)<\/li>\n<li>Komplette Abwicklung von Papiereinreichungen<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Die Erstellung von korrekt formatierter Quelldokumentation f\u00fcr Einreichungen im eCTD (oder NeeS) Format ist unter Umst\u00e4nden aufwendiger als die Erstellung des elektronischen Dossiers selbst. Um die immer strikter kontrollierte Einhaltung formaler Kriterien zu garantieren, m\u00fcssen neben funktionalen Anforderungen an die &hellip; <a class=\"kt-excerpt-readmore\" href=\"https:\/\/exalon.com\/de\/ectd-services\/ectd-readiness\/\" aria-label=\"eCTD Readiness\">Weiterlesen<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":8,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-feature.php","meta":{"footnotes":""},"class_list":["post-115","page","type-page","status-publish","hentry"],"translation":{"provider":"WPGlobus","version":"3.0.0","language":"de","enabled_languages":["en","de"],"languages":{"en":{"title":true,"content":true,"excerpt":false},"de":{"title":true,"content":true,"excerpt":false}}},"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO 5.0.2.1 - aioseo.com -->\n\t<meta name=\"robots\" content=\"max-image-preview:large\" \/>\n\t<meta name=\"google-site-verification\" 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