{"id":7717,"date":"2026-07-03T17:12:11","date_gmt":"2026-07-03T15:12:11","guid":{"rendered":"https:\/\/mediconomics.com\/blog\/"},"modified":"2026-09-07T11:01:01","modified_gmt":"2026-09-07T09:01:01","slug":"blog","status":"publish","type":"page","link":"https:\/\/mediconomics.com\/en\/blog\/","title":{"rendered":"Blog"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7717\" class=\"elementor elementor-7717 elementor-6069\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-de88050 e-flex e-con-boxed e-con e-parent\" data-id=\"de88050\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5e749e6 elementor-widget elementor-widget-heading\" data-id=\"5e749e6\" 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<h1 class=\"elementor-heading-title elementor-size-default\">Blog<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-05ac22c e-flex e-con-boxed e-con e-parent\" data-id=\"05ac22c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-21eebb7 elementor-grid-3 elementor-grid-tablet-2 elementor-grid-mobile-1 elementor-posts--thumbnail-top elementor-widget elementor-widget-posts\" data-id=\"21eebb7\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;classic_columns&quot;:&quot;3&quot;,&quot;classic_columns_tablet&quot;:&quot;2&quot;,&quot;classic_columns_mobile&quot;:&quot;1&quot;,&quot;classic_row_gap&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:35,&quot;sizes&quot;:[]},&quot;classic_row_gap_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;classic_row_gap_tablet_extra&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;classic_row_gap_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;classic_row_gap_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"posts.classic\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-posts-container elementor-posts elementor-posts--skin-classic elementor-grid\" role=\"list\">\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-7722 post type-post status-publish format-standard has-post-thumbnail hentry category-uncategorized\" role=\"listitem\">\n\t\t\t\t<a class=\"elementor-post__thumbnail__link\" href=\"https:\/\/mediconomics.com\/en\/medical-writing-in-a-cro-which-documents-really-count\/\" tabindex=\"-1\" >\n\t\t\t<div class=\"elementor-post__thumbnail\"><img fetchpriority=\"high\" decoding=\"async\" width=\"300\" height=\"167\" src=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2026\/07\/medical-writing-im-klinischen-alltag-welche-dokumente-ein-cr.jpg\" class=\"attachment-medium size-medium wp-image-7059\" alt=\"\" \/><\/div>\n\t\t<\/a>\n\t\t\t\t<div class=\"elementor-post__text\">\n\t\t\t\t<h3 class=\"elementor-post__title\">\n\t\t\t<a href=\"https:\/\/mediconomics.com\/en\/medical-writing-in-a-cro-which-documents-really-count\/\" >\n\t\t\t\tMedical Writing in a CRO: Which Documents Really Count\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t<div class=\"elementor-post__meta-data\">\n\t\t\t\t\t<span class=\"elementor-post-date\">\n\t\t\t17. September 2026\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-post__excerpt\">\n\t\t\t<p>In Medical Writing, a CRO creates all regulatorily relevant documents throughout the study lifecycle: the study protocol, Investigator&#8217;s Brochure (IB), Informed Consent Form (ICF), and IMPD during the start-up phase;<\/p>\n\t\t<\/div>\n\t\t\n\t\t<a class=\"elementor-post__read-more\" href=\"https:\/\/mediconomics.com\/en\/medical-writing-in-a-cro-which-documents-really-count\/\" aria-label=\"Read more about Medical Writing in a CRO: Which Documents Really Count\" tabindex=\"-1\" >\n\t\t\tRead More\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-7723 post type-post status-publish format-standard has-post-thumbnail hentry category-uncategorized\" role=\"listitem\">\n\t\t\t\t<a class=\"elementor-post__thumbnail__link\" href=\"https:\/\/mediconomics.com\/en\/ecrf-selection-a-regulatory-imperative-not-an-it-procurement\/\" tabindex=\"-1\" >\n\t\t\t<div class=\"elementor-post__thumbnail\"><img decoding=\"async\" width=\"300\" height=\"167\" src=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2026\/07\/ecrf-auswahl-fur-klinische-prufungen-worauf-sponsoren-achten.jpg\" class=\"attachment-medium size-medium wp-image-7052\" alt=\"\" \/><\/div>\n\t\t<\/a>\n\t\t\t\t<div class=\"elementor-post__text\">\n\t\t\t\t<h3 class=\"elementor-post__title\">\n\t\t\t<a href=\"https:\/\/mediconomics.com\/en\/ecrf-selection-a-regulatory-imperative-not-an-it-procurement\/\" >\n\t\t\t\teCRF Selection: A Regulatory Imperative, Not an IT Procurement\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t<div class=\"elementor-post__meta-data\">\n\t\t\t\t\t<span class=\"elementor-post-date\">\n\t\t\t1. September 2026\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-post__excerpt\">\n\t\t\t<p>A Phase II study with 12 centers had to switch eCRF systems three weeks before First-Patient-In because the audit trail was not exportable. Study start: delayed by four months. Additional<\/p>\n\t\t<\/div>\n\t\t\n\t\t<a class=\"elementor-post__read-more\" href=\"https:\/\/mediconomics.com\/en\/ecrf-selection-a-regulatory-imperative-not-an-it-procurement\/\" aria-label=\"Read more about eCRF Selection: A Regulatory Imperative, Not an IT Procurement\" tabindex=\"-1\" >\n\t\t\tRead More\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-7868 post type-post status-publish format-standard has-post-thumbnail hentry category-uncategorized\" role=\"listitem\">\n\t\t\t\t<a class=\"elementor-post__thumbnail__link\" href=\"https:\/\/mediconomics.com\/en\/gcp-inspection-inspection-readiness-as-a-permanent-operational-state\/\" tabindex=\"-1\" >\n\t\t\t<div class=\"elementor-post__thumbnail\"><img decoding=\"async\" width=\"300\" height=\"167\" src=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2026\/07\/gcp-inspektion-wie-bereitet-man-sich-als-sponsor-vor-1.jpg\" class=\"attachment-medium size-medium wp-image-7045\" alt=\"\" \/><\/div>\n\t\t<\/a>\n\t\t\t\t<div class=\"elementor-post__text\">\n\t\t\t\t<h3 class=\"elementor-post__title\">\n\t\t\t<a href=\"https:\/\/mediconomics.com\/en\/gcp-inspection-inspection-readiness-as-a-permanent-operational-state\/\" >\n\t\t\t\tGCP Inspection: Inspection Readiness as a Permanent Operational State\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t<div class=\"elementor-post__meta-data\">\n\t\t\t\t\t<span class=\"elementor-post-date\">\n\t\t\t25. August 2026\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-post__excerpt\">\n\t\t\t<p>Monday morning, 9:14 AM. A sponsor receives notification of a BfArM inspection scheduled for Thursday. The TMF index shows 340 missing documents. What follows is no longer preparation\u2014only damage control.<\/p>\n\t\t<\/div>\n\t\t\n\t\t<a class=\"elementor-post__read-more\" href=\"https:\/\/mediconomics.com\/en\/gcp-inspection-inspection-readiness-as-a-permanent-operational-state\/\" aria-label=\"Read more about GCP Inspection: Inspection Readiness as a Permanent Operational State\" tabindex=\"-1\" >\n\t\t\tRead More\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-7863 post type-post status-publish format-standard has-post-thumbnail hentry category-uncategorized\" role=\"listitem\">\n\t\t\t\t<a class=\"elementor-post__thumbnail__link\" href=\"https:\/\/mediconomics.com\/en\/ctis-the-regulatory-operating-system-for-eu-wide-clinical-trials\/\" tabindex=\"-1\" >\n\t\t\t<div class=\"elementor-post__thumbnail\"><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"167\" src=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2026\/07\/ctis-leicht-erklart-was-sponsoren-beim-eu-weiten-trial-antra.jpg\" class=\"attachment-medium size-medium wp-image-6864\" alt=\"\" \/><\/div>\n\t\t<\/a>\n\t\t\t\t<div class=\"elementor-post__text\">\n\t\t\t\t<h3 class=\"elementor-post__title\">\n\t\t\t<a href=\"https:\/\/mediconomics.com\/en\/ctis-the-regulatory-operating-system-for-eu-wide-clinical-trials\/\" >\n\t\t\t\tCTIS: The Regulatory Operating System for EU-wide Clinical Trials\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t<div class=\"elementor-post__meta-data\">\n\t\t\t\t\t<span class=\"elementor-post-date\">\n\t\t\t13. July 2026\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-post__excerpt\">\n\t\t\t<p>Since January 31, 2025, the Clinical Trials Information System (CTIS) has been the mandatory EU-wide platform for the submission, assessment, and supervision of all clinical trials with human medicinal products<\/p>\n\t\t<\/div>\n\t\t\n\t\t<a class=\"elementor-post__read-more\" href=\"https:\/\/mediconomics.com\/en\/ctis-the-regulatory-operating-system-for-eu-wide-clinical-trials\/\" aria-label=\"Read more about CTIS: The Regulatory Operating System for EU-wide Clinical Trials\" tabindex=\"-1\" >\n\t\t\tRead More\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-7867 post type-post status-publish format-standard has-post-thumbnail hentry category-uncategorized\" role=\"listitem\">\n\t\t\t\t<a class=\"elementor-post__thumbnail__link\" href=\"https:\/\/mediconomics.com\/en\/sponsor-vs-cro-who-truly-bears-the-responsibility-in-a-clinical-trial\/\" tabindex=\"-1\" >\n\t\t\t<div class=\"elementor-post__thumbnail\"><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"167\" src=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2026\/07\/sponsor-vs-cro-wer-ist-fur-was-verantwortlich-in-einer-klini.jpg\" class=\"attachment-medium size-medium wp-image-6850\" alt=\"\" \/><\/div>\n\t\t<\/a>\n\t\t\t\t<div class=\"elementor-post__text\">\n\t\t\t\t<h3 class=\"elementor-post__title\">\n\t\t\t<a href=\"https:\/\/mediconomics.com\/en\/sponsor-vs-cro-who-truly-bears-the-responsibility-in-a-clinical-trial\/\" >\n\t\t\t\tSponsor vs. CRO: Who truly bears the responsibility in a clinical trial?\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t<div class=\"elementor-post__meta-data\">\n\t\t\t\t\t<span class=\"elementor-post-date\">\n\t\t\t3. July 2026\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-post__excerpt\">\n\t\t\t<p>The overall regulatory responsibility for a clinical trial remains legally with the sponsor \u2013 even in the case of full outsourcing to a CRO. Monitoring, data management, statistics, and regulatory<\/p>\n\t\t<\/div>\n\t\t\n\t\t<a class=\"elementor-post__read-more\" href=\"https:\/\/mediconomics.com\/en\/sponsor-vs-cro-who-truly-bears-the-responsibility-in-a-clinical-trial\/\" aria-label=\"Read more about Sponsor vs. CRO: Who truly bears the responsibility in a clinical trial?\" tabindex=\"-1\" >\n\t\t\tRead More\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t<\/div>\n\t\t\n\t\t\t\t\t\t<\/div>\n\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},"excerpt":{"rendered":"<p>Blog<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-7717","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/pages\/7717","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/comments?post=7717"}],"version-history":[{"count":1,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/pages\/7717\/revisions"}],"predecessor-version":[{"id":7718,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/pages\/7717\/revisions\/7718"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7717"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}