{"id":8915,"date":"2026-04-09T12:49:47","date_gmt":"2026-04-09T10:49:47","guid":{"rendered":"https:\/\/trigas-trigas-kunden.digitalspital.de\/nicht-kategorisiert\/companion-diagnostics-requirements-for-companion-diagnostics\/"},"modified":"2026-06-11T15:44:02","modified_gmt":"2026-06-11T13:44:02","slug":"companion-diagnostics","status":"publish","type":"post","link":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/companion-diagnostics\/","title":{"rendered":"Companion Diagnostics: requirements for CDx briefly explained"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8915\" class=\"elementor elementor-8915 elementor-4849\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1298576 e-flex e-con-boxed e-con e-parent\" data-id=\"1298576\" 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-d913b9a elementor-widget elementor-widget-image\" data-id=\"d913b9a\" 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=\"800\" height=\"370\" src=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-companion-diagnostics_1920x1080-V2-1024x473.webp\" class=\"attachment-large size-large wp-image-8919\" alt=\"A person wearing blue gloves and a lab coat places a test tube into a rack alongside others in a laboratory setting, preparing samples for companion diagnostics.\" srcset=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-companion-diagnostics_1920x1080-V2-1024x473.webp 1024w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-companion-diagnostics_1920x1080-V2-300x138.webp 300w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-companion-diagnostics_1920x1080-V2-768x354.webp 768w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-companion-diagnostics_1920x1080-V2-1536x709.webp 1536w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-companion-diagnostics_1920x1080-V2.webp 1950w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-721b626 elementor-widget elementor-widget-spacer\" data-id=\"721b626\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7b573dc elementor-widget elementor-widget-heading\" data-id=\"7b573dc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">What are Companion Diagnostics (CDx)?<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b293165 elementor-widget elementor-widget-text-editor\" data-id=\"b293165\" 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>Companion Diagnostics (CDx) are diagnostic tests that determine whether a patient is suitable for a specific therapy. They are <strong>a cornerstone of personalised medicine<\/strong>.<\/p><p>Under IVDR Art. 2(7), Companion Diagnostics are devices that are essential for the <strong>safe and effective use of a corresponding medicinal product<\/strong> in order to:<\/p><ul><li>Identify, before and\/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or<\/li><li>Identify, before and\/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product.<\/li><\/ul><p><br \/>Devices used to monitor treatment with a medicinal product \u2013 e.g. to ensure that the concentration remains within the therapeutic window \u2013 are not considered to be CDx (MDCG 2020-16, Rev. 4, Section 4(f)). This is a key distinction between the use of the term in Europe and in the USA.<\/p><p><strong>Note:<\/strong> Under the IVDR, CDx are generally classified as Class C IVDs. Conformity assessment requires the involvement of a <strong><a href=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/notified-bodies\/\" target=\"_blank\" rel=\"noopener\">Notified Body<\/a><\/strong> and consultation with the relevant medicines authority (IVDR Art. 48(3)).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-45018c4 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"45018c4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-311399e e-con-full e-flex e-con e-child\" data-id=\"311399e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-684553c elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"684553c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-quote-left\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 256h-80v-64c0-35.3 28.7-64 64-64h8c13.3 0 24-10.7 24-24V56c0-13.3-10.7-24-24-24h-8c-88.4 0-160 71.6-160 160v240c0 26.5 21.5 48 48 48h128c26.5 0 48-21.5 48-48V304c0-26.5-21.5-48-48-48zm-288 0H96v-64c0-35.3 28.7-64 64-64h8c13.3 0 24-10.7 24-24V56c0-13.3-10.7-24-24-24h-8C71.6 32 0 103.6 0 192v240c0 26.5 21.5 48 48 48h128c26.5 0 48-21.5 48-48V304c0-26.5-21.5-48-48-48z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-88ccb4d elementor-widget elementor-widget-text-editor\" data-id=\"88ccb4d\" 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>\u201c<em>We support CDx projects for pharmaceutical companies of various sizes \u2013 from early-stage biotechs to global corporations. What they all have in common: they need reliability, speed, and a partner who thinks ahead regulatorily. That is exactly what we provide.&#8221;<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-576a45b e-con-full e-flex e-con e-child\" data-id=\"576a45b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-659a053 elementor-widget elementor-widget-text-editor\" data-id=\"659a053\" 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>\u2013 Dr. Andreas Franke, Managing Director \/ COO<\/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 class=\"elementor-element elementor-element-a44d62f elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"a44d62f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-70045d2 elementor-widget elementor-widget-heading\" data-id=\"70045d2\" 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\">What Are the Requirements for CDx Performance Studies?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4ff36bd elementor-widget elementor-widget-text-editor\" data-id=\"4ff36bd\" 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>CDx performance studies are subject to the same regulatory requirements as all IVD performance studies\u00a0(<a href=\"https:\/\/www.bfarm.de\/EN\/Medical-devices\/Tasks\/Special-topics\/Companion-diagnostics\/_node.html\" target=\"_blank\" rel=\"noopener\">see BfArM overview on CDx<\/a>) \u2013 with additional CDx-specific considerations:<\/p><ul><li>Analytical performance: evidence requirements equivalent to those for other IVDs (including sensitivity and specificity, accuracy, precision, limit of detection, interference, and robustness)<\/li><li>Clinical performance: <strong>the goal is to demonstrate that the CDx correctly stratifies patients for a given therapy. <\/strong>There are two common approaches. For a CDx with a numerical cut-off, they differ as follows:<ul><li><p class=\"p1\">Interventional clinical performance study (IVDR Art. 2(46)): the CDx result guides therapy assignment, providing evidence of the clinical benefit of the cut-off and efficacy in CDx-positive versus CDx-negative groups.<\/p><\/li><li><p class=\"p1\">Performance study using left-over samples (IVDR Art. 58(2)): the use of existing samples and datasets without therapeutic influence primarily serves to demonstrate sensitivity and specificity against a reference standard, and to confirm a predefined cut-off.<\/p><\/li><\/ul><\/li><li><p class=\"p1\">Performance evaluation<span style=\"font-family: -apple-system, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', Arial, 'Noto Sans', sans-serif, 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Noto Color Emoji';\">: Overall body of evidence from scientific validity, analytical and clinical performance (IVDR Annex XIII)<\/span><\/p><\/li><\/ul><p>CDx studies can be conducted in parallel with Phase III studies of the corresponding medicinal product (co-development), but require separate study documents: a Clinical Performance Study Plan (CPSP) for the CDx study and a distinct study protocol for the medicinal product study. For interventional CDx studies, ethics committee approval, patient informed consent (ICF), applicable ISO standards, and risk-based monitoring in accordance with GCP must be in place.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b63ae84 elementor-widget elementor-widget-spacer\" data-id=\"b63ae84\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\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-a3fb4ec e-flex e-con-boxed e-con e-parent\" data-id=\"a3fb4ec\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-dea81fe e-con-full e-flex e-con e-child\" data-id=\"dea81fe\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-26d74f9 e-con-full e-flex e-con e-child\" data-id=\"26d74f9\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-2ece02c e-con-full e-flex e-con e-child\" data-id=\"2ece02c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1899b22 elementor-widget elementor-widget-heading\" data-id=\"1899b22\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">A well-designed and validated CDx is the key to the success of a therapy and delivers real clinical benefit. As specialists in CDx performance studies, we are here to support you \u2013 from study planning and statistics to GCP-compliant documentation (TMF\/eTMF). Get in touch to discuss your project.\n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-19ba9eb elementor-mobile-align-left elementor-widget elementor-widget-button\" data-id=\"19ba9eb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Contact us now<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-39bb581 e-con-full e-flex e-con e-child\" data-id=\"39bb581\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-a82256c e-con-full e-flex eael_liquid_glass-effect1 e-con e-child\" data-id=\"a82256c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-980f524 elementor-widget elementor-widget-heading\" data-id=\"980f524\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\"><b>Dr. Andreas Franke,<\/b> Managing Director \/ COO<\/h4>\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-44bc32fd e-flex e-con-boxed e-con e-parent\" data-id=\"44bc32fd\" 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-25b6343d elementor-widget elementor-widget-heading\" data-id=\"25b6343d\" 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\">You Might Also Be Interested In<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-41bb5b86 elementor-widget elementor-widget-spacer\" data-id=\"41bb5b86\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7afa58df elementor-grid-3 elementor-grid-tablet-2 elementor-grid-mobile-1 elementor-widget elementor-widget-loop-grid\" data-id=\"7afa58df\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;template_id&quot;:5310,&quot;_skin&quot;:&quot;post&quot;,&quot;columns&quot;:&quot;3&quot;,&quot;columns_tablet&quot;:&quot;2&quot;,&quot;columns_mobile&quot;:&quot;1&quot;,&quot;edit_handle_selector&quot;:&quot;[data-elementor-type=\\&quot;loop-item\\&quot;]&quot;,&quot;row_gap&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;row_gap_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;row_gap_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"loop-grid.post\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-loop-container elementor-grid\" role=\"list\">\n\t\t<style id=\"loop-5310\">.elementor-5310 .elementor-element.elementor-element-945d7a9{--display:flex;--flex-direction:column;--container-widget-width:100%;--container-widget-height:initial;--container-widget-flex-grow:0;--container-widget-align-self:initial;--flex-wrap-mobile:wrap;--border-radius:20px 20px 20px 20px;box-shadow:0px 6px 38px 0px rgba(0, 0, 0, 0.23);--padding-top:0px;--padding-bottom:0px;--padding-left:0px;--padding-right:0px;}.elementor-5310 .elementor-element.elementor-element-945d7a9:not(.elementor-motion-effects-element-type-background), .elementor-5310 .elementor-element.elementor-element-945d7a9 > .elementor-motion-effects-container > .elementor-motion-effects-layer{background-color:var( --e-global-color-e232888 );}.elementor-widget-theme-post-featured-image .widget-image-caption{color:var( --e-global-color-text );font-family:var( --e-global-typography-text-font-family ), Sans-serif;font-size:var( --e-global-typography-text-font-size );font-weight:var( --e-global-typography-text-font-weight );}.elementor-5310 .elementor-element.elementor-element-6554424 img{border-radius:20px 20px 0px 0px;}.elementor-5310 .elementor-element.elementor-element-37ab487{--display:flex;--padding-top:0px;--padding-bottom:25px;--padding-left:25px;--padding-right:25px;}.elementor-widget-heading .elementor-heading-title{font-family:var( --e-global-typography-primary-font-family ), Sans-serif;font-weight:var( --e-global-typography-primary-font-weight );color:var( --e-global-color-primary );}.elementor-5310 .elementor-element.elementor-element-2ec8b90 .elementor-heading-title{font-family:\"Nunito Sans\", Sans-serif;font-weight:600;color:var( --e-global-color-text );}.elementor-widget-theme-post-excerpt{font-family:var( --e-global-typography-text-font-family ), Sans-serif;font-size:var( --e-global-typography-text-font-size );font-weight:var( --e-global-typography-text-font-weight );color:var( --e-global-color-text );}.elementor-5310 .elementor-element.elementor-element-45cfdc7{color:var( --e-global-color-text );}.elementor-widget-button .elementor-button{font-family:var( --e-global-typography-accent-font-family ), Sans-serif;font-weight:var( --e-global-typography-accent-font-weight );background-color:var( --e-global-color-accent );}.elementor-5310 .elementor-element.elementor-element-8e4d8fb .elementor-button{background-color:var( --e-global-color-primary );}.elementor-5310 .elementor-element.elementor-element-8e4d8fb .elementor-button:hover, .elementor-5310 .elementor-element.elementor-element-8e4d8fb .elementor-button:focus{background-color:var( --e-global-color-secondary );}@media(max-width:1024px){.elementor-widget-theme-post-featured-image .widget-image-caption{font-size:var( --e-global-typography-text-font-size );}.elementor-widget-theme-post-excerpt{font-size:var( --e-global-typography-text-font-size );}}@media(max-width:767px){.elementor-widget-theme-post-featured-image .widget-image-caption{font-size:var( --e-global-typography-text-font-size );}.elementor-widget-theme-post-excerpt{font-size:var( --e-global-typography-text-font-size );}}<\/style>\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"5310\" class=\"elementor elementor-5310 e-loop-item e-loop-item-7617 post-7617 page type-page status-publish has-post-thumbnail hentry\" data-elementor-post-type=\"elementor_library\" data-custom-edit-handle=\"1\">\n\t\t\t<div class=\"elementor-element elementor-element-945d7a9 e-flex e-con-boxed e-con e-parent\" data-id=\"945d7a9\" 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-6554424 elementor-widget elementor-widget-theme-post-featured-image elementor-widget-image\" data-id=\"6554424\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-featured-image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"800\" height=\"480\" src=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/03\/triga-s-Beitragsbild_Auftragsanalytik-und-applikation-1000x600-2-1024x614.webp\" class=\"attachment-large size-large wp-image-7619\" alt=\"A scientist wearing blue gloves and safety glasses examines samples on a slide through a microscope in a laboratory, conducting ivdr performance studies with scientific equipment visible in the background.\" srcset=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/03\/triga-s-Beitragsbild_Auftragsanalytik-und-applikation-1000x600-2-1024x614.webp 1024w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/03\/triga-s-Beitragsbild_Auftragsanalytik-und-applikation-1000x600-2-300x180.webp 300w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/03\/triga-s-Beitragsbild_Auftragsanalytik-und-applikation-1000x600-2-768x461.webp 768w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/03\/triga-s-Beitragsbild_Auftragsanalytik-und-applikation-1000x600-2-1536x922.webp 1536w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/03\/triga-s-Beitragsbild_Auftragsanalytik-und-applikation-1000x600-2.webp 2000w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-37ab487 e-con-full e-flex e-con e-child\" data-id=\"37ab487\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-45cfdc7 elementor-widget elementor-widget-theme-post-excerpt\" data-id=\"45cfdc7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-excerpt.default\">\n\t\t\t\t\tFrom study planning through execution to submission-ready reports: TRIGA-S supports you with specialised expertise, a modular service portfolio, and a dedicated point of contact.\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8e4d8fb elementor-widget elementor-widget-button\" data-id=\"8e4d8fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/diagnostics\/\" id=\"read-more-button\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Merh erfahren<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\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\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"5310\" class=\"elementor elementor-5310 e-loop-item e-loop-item-7380 post-7380 page type-page status-publish has-post-thumbnail hentry\" data-elementor-post-type=\"elementor_library\" data-custom-edit-handle=\"1\">\n\t\t\t<div class=\"elementor-element elementor-element-945d7a9 e-flex e-con-boxed e-con e-parent\" data-id=\"945d7a9\" 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-6554424 elementor-widget elementor-widget-theme-post-featured-image elementor-widget-image\" data-id=\"6554424\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-featured-image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"800\" height=\"480\" src=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_pharma-1000x600-1-1024x614.webp\" class=\"attachment-large size-large wp-image-7384\" alt=\"A scientist wearing safety goggles, gloves, and a lab coat stands in a laboratory specializing in pharma services, holding a piece of lab equipment and smiling at the camera. Shelves and lab supplies are visible in the background.\" srcset=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_pharma-1000x600-1-1024x614.webp 1024w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_pharma-1000x600-1-300x180.webp 300w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_pharma-1000x600-1-768x461.webp 768w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_pharma-1000x600-1-1536x922.webp 1536w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_pharma-1000x600-1.webp 2000w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-37ab487 e-con-full e-flex e-con e-child\" data-id=\"37ab487\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-45cfdc7 elementor-widget elementor-widget-theme-post-excerpt\" data-id=\"45cfdc7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-excerpt.default\">\n\t\t\t\t\tFrom exploratory R&amp;D analytics to submission-ready CDx validation: We support pharmaceutical companies with modular, IVDR-specialised services and dedicated points of contact.\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8e4d8fb elementor-widget elementor-widget-button\" data-id=\"8e4d8fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/pharma-services\/\" id=\"read-more-button\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Merh erfahren<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\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\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"5310\" class=\"elementor elementor-5310 e-loop-item e-loop-item-8895 post-8895 post type-post status-publish format-standard has-post-thumbnail hentry category-cro-wiki\" data-elementor-post-type=\"elementor_library\" data-custom-edit-handle=\"1\">\n\t\t\t<div class=\"elementor-element elementor-element-945d7a9 e-flex e-con-boxed e-con e-parent\" data-id=\"945d7a9\" 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-6554424 elementor-widget elementor-widget-theme-post-featured-image elementor-widget-image\" data-id=\"6554424\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-featured-image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"480\" src=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-TMF-1000x600-1-1024x614.webp\" class=\"attachment-large size-large wp-image-8896\" alt=\"Two people sit at a table with open laptops, one pointing at a screen while the other looks on, suggesting a collaborative work session focused on organizing the trial master file.\" srcset=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-TMF-1000x600-1-1024x614.webp 1024w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-TMF-1000x600-1-300x180.webp 300w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-TMF-1000x600-1-768x461.webp 768w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-TMF-1000x600-1-1536x922.webp 1536w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-TMF-1000x600-1.webp 2000w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-37ab487 e-con-full e-flex e-con e-child\" data-id=\"37ab487\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-45cfdc7 elementor-widget elementor-widget-theme-post-excerpt\" data-id=\"45cfdc7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-excerpt.default\">\n\t\t\t\t\tWhat is the TMF (Trial Master File) and why is it crucial for studies? Find out why it is considered the \u201cmemory\u201d of a study and which regulatory requirements it must meet.\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8e4d8fb elementor-widget elementor-widget-button\" data-id=\"8e4d8fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/trial-master-file\/\" id=\"read-more-button\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Merh erfahren<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\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\t\t<\/div>\n\t\t\t\t<\/div>\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<div class=\"elementor-element elementor-element-a8b55dc e-flex e-con-boxed e-con e-parent\" data-id=\"a8b55dc\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-bc798ac e-con-full e-flex e-con e-child\" data-id=\"bc798ac\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5614427 elementor-widget__width-initial elementor-widget elementor-widget-n-accordion\" data-id=\"5614427\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-9020\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-9020\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Abbreviations <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fontello fontelloarrow-up-right\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fontello fontelloarrow-down-right\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-9020\" class=\"elementor-element elementor-element-d303422 e-con-full e-flex e-con e-child\" data-id=\"d303422\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4859b11 elementor-widget elementor-widget-text-editor\" data-id=\"4859b11\" 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>BfArM: Federal Institute for Drugs and Medical Devices<\/p><p>CDx: Companion Diagnostics<\/p><p>CPSP: Clinical Performance Study Plan<\/p><p>eTMF: electronic Trial Master File<\/p><p>GCP: Good Clinical Practice<\/p><p>ICF: Informed Consent Form<\/p><p>ISO: International Organization for Standardization<\/p><p>IVD: In vitro diagnostic<\/p><p>IVDR: In Vitro Diagnostic Regulation<\/p><p>MDCG: Medical Device Coordination Group<\/p><p>TMF: Trial Master File<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\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>What are Companion Diagnostics (CDx)? Find out why they are a cornerstone of personalised medicine and what requirements they need to meet.<\/p>\n","protected":false},"author":3,"featured_media":8920,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[25],"tags":[],"class_list":["post-8915","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cro-wiki"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Companion Diagnostics: Requirements for CDx<\/title>\n<meta name=\"description\" content=\"Companion Diagnostics (CDx) performance studies follow IVD regulations \u2013 with additional CDx-specific requirements. An overview of what applies.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/companion-diagnostics\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"TMF (Trial Master File) and eTMF: Overview of requirements\" \/>\n<meta property=\"og:description\" content=\"Companion Diagnostics (CDx) are essential for personalized medicine. The requirements for their performance studies are fundamentally the same as for IVDs.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/companion-diagnostics\/\" \/>\n<meta property=\"og:site_name\" content=\"Triga-S Homepage\" \/>\n<meta property=\"article:published_time\" content=\"2026-04-09T10:49:47+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-06-11T13:44:02+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-companion-diagnostics-1000x600-V2.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"2000\" \/>\n\t<meta property=\"og:image:height\" content=\"1200\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"author\" content=\"maria.schaab\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:title\" content=\"TMF (Trial Master File) and eTMF: Overview of requirements\" \/>\n<meta name=\"twitter:description\" content=\"Companion Diagnostics (CDx) are essential for personalized medicine. The requirements for their performance studies are fundamentally the same as for IVDs.\" \/>\n<meta name=\"twitter:image\" content=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-companion-diagnostics-1000x600-1-1024x614.webp\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"maria.schaab\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/en\\\/cro-wiki\\\/companion-diagnostics\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/en\\\/cro-wiki\\\/companion-diagnostics\\\/\"},\"author\":{\"name\":\"maria.schaab\",\"@id\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/#\\\/schema\\\/person\\\/a224c2f816c9500adb7683c670f0d81c\"},\"headline\":\"Companion Diagnostics: requirements for CDx briefly explained\",\"datePublished\":\"2026-04-09T10:49:47+00:00\",\"dateModified\":\"2026-06-11T13:44:02+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/en\\\/cro-wiki\\\/companion-diagnostics\\\/\"},\"wordCount\":630,\"publisher\":{\"@id\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/en\\\/cro-wiki\\\/companion-diagnostics\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/triga-s-Beitragsbild_Beitrag-companion-diagnostics-1000x600-V2.webp\",\"articleSection\":[\"CRO Wiki\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/en\\\/cro-wiki\\\/companion-diagnostics\\\/\",\"url\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/en\\\/cro-wiki\\\/companion-diagnostics\\\/\",\"name\":\"Companion Diagnostics: Requirements for CDx\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/en\\\/cro-wiki\\\/companion-diagnostics\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/en\\\/cro-wiki\\\/companion-diagnostics\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/triga-s-Beitragsbild_Beitrag-companion-diagnostics-1000x600-V2.webp\",\"datePublished\":\"2026-04-09T10:49:47+00:00\",\"dateModified\":\"2026-06-11T13:44:02+00:00\",\"description\":\"Companion Diagnostics (CDx) performance studies follow IVD regulations \u2013 with additional CDx-specific requirements. An overview of what applies.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/en\\\/cro-wiki\\\/companion-diagnostics\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/en\\\/cro-wiki\\\/companion-diagnostics\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/en\\\/cro-wiki\\\/companion-diagnostics\\\/#primaryimage\",\"url\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/triga-s-Beitragsbild_Beitrag-companion-diagnostics-1000x600-V2.webp\",\"contentUrl\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/triga-s-Beitragsbild_Beitrag-companion-diagnostics-1000x600-V2.webp\",\"width\":2000,\"height\":1200,\"caption\":\"A person wearing blue gloves and a white lab coat places a test tube into a rack, surrounded by other test tubes in a companion diagnostics laboratory setting.\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/en\\\/cro-wiki\\\/companion-diagnostics\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Companion Diagnostics: requirements for CDx briefly explained\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/#website\",\"url\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/\",\"name\":\"TRIGA-S Homepage\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/#organization\",\"name\":\"Triga-S Homepage\",\"url\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/wp-content\\\/uploads\\\/2026\\\/01\\\/Triga-S-Logo-Color.webp\",\"contentUrl\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/wp-content\\\/uploads\\\/2026\\\/01\\\/Triga-S-Logo-Color.webp\",\"width\":1460,\"height\":369,\"caption\":\"Triga-S Homepage\"},\"image\":{\"@id\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/#\\\/schema\\\/person\\\/a224c2f816c9500adb7683c670f0d81c\",\"name\":\"maria.schaab\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/84ecf33396ba41c0b7cecf4ec639ad2064e7f0e29c951de791ddadde3f5d9155?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/84ecf33396ba41c0b7cecf4ec639ad2064e7f0e29c951de791ddadde3f5d9155?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/84ecf33396ba41c0b7cecf4ec639ad2064e7f0e29c951de791ddadde3f5d9155?s=96&d=mm&r=g\",\"caption\":\"maria.schaab\"},\"url\":\"https:\\\/\\\/trigas-trigas-kunden.digitalspital.de\\\/en\\\/author\\\/maria-schaab\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Companion Diagnostics: Requirements for CDx","description":"Companion Diagnostics (CDx) performance studies follow IVD regulations \u2013 with additional CDx-specific requirements. An overview of what applies.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/companion-diagnostics\/","og_locale":"en_US","og_type":"article","og_title":"TMF (Trial Master File) and eTMF: Overview of requirements","og_description":"Companion Diagnostics (CDx) are essential for personalized medicine. The requirements for their performance studies are fundamentally the same as for IVDs.","og_url":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/companion-diagnostics\/","og_site_name":"Triga-S Homepage","article_published_time":"2026-04-09T10:49:47+00:00","article_modified_time":"2026-06-11T13:44:02+00:00","og_image":[{"width":2000,"height":1200,"url":"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-companion-diagnostics-1000x600-V2.webp","type":"image\/webp"}],"author":"maria.schaab","twitter_card":"summary_large_image","twitter_title":"TMF (Trial Master File) and eTMF: Overview of requirements","twitter_description":"Companion Diagnostics (CDx) are essential for personalized medicine. The requirements for their performance studies are fundamentally the same as for IVDs.","twitter_image":"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-companion-diagnostics-1000x600-1-1024x614.webp","twitter_misc":{"Written by":"maria.schaab","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/companion-diagnostics\/#article","isPartOf":{"@id":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/companion-diagnostics\/"},"author":{"name":"maria.schaab","@id":"https:\/\/trigas-trigas-kunden.digitalspital.de\/#\/schema\/person\/a224c2f816c9500adb7683c670f0d81c"},"headline":"Companion Diagnostics: requirements for CDx briefly explained","datePublished":"2026-04-09T10:49:47+00:00","dateModified":"2026-06-11T13:44:02+00:00","mainEntityOfPage":{"@id":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/companion-diagnostics\/"},"wordCount":630,"publisher":{"@id":"https:\/\/trigas-trigas-kunden.digitalspital.de\/#organization"},"image":{"@id":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/companion-diagnostics\/#primaryimage"},"thumbnailUrl":"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-companion-diagnostics-1000x600-V2.webp","articleSection":["CRO Wiki"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/companion-diagnostics\/","url":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/companion-diagnostics\/","name":"Companion Diagnostics: Requirements for CDx","isPartOf":{"@id":"https:\/\/trigas-trigas-kunden.digitalspital.de\/#website"},"primaryImageOfPage":{"@id":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/companion-diagnostics\/#primaryimage"},"image":{"@id":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/companion-diagnostics\/#primaryimage"},"thumbnailUrl":"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-companion-diagnostics-1000x600-V2.webp","datePublished":"2026-04-09T10:49:47+00:00","dateModified":"2026-06-11T13:44:02+00:00","description":"Companion Diagnostics (CDx) performance studies follow IVD regulations \u2013 with additional CDx-specific requirements. An overview of what applies.","breadcrumb":{"@id":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/companion-diagnostics\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/companion-diagnostics\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/companion-diagnostics\/#primaryimage","url":"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-companion-diagnostics-1000x600-V2.webp","contentUrl":"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-companion-diagnostics-1000x600-V2.webp","width":2000,"height":1200,"caption":"A person wearing blue gloves and a white lab coat places a test tube into a rack, surrounded by other test tubes in a companion diagnostics laboratory setting."},{"@type":"BreadcrumbList","@id":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/companion-diagnostics\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/trigas-trigas-kunden.digitalspital.de\/"},{"@type":"ListItem","position":2,"name":"Companion Diagnostics: requirements for CDx briefly explained"}]},{"@type":"WebSite","@id":"https:\/\/trigas-trigas-kunden.digitalspital.de\/#website","url":"https:\/\/trigas-trigas-kunden.digitalspital.de\/","name":"TRIGA-S Homepage","description":"","publisher":{"@id":"https:\/\/trigas-trigas-kunden.digitalspital.de\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/trigas-trigas-kunden.digitalspital.de\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/trigas-trigas-kunden.digitalspital.de\/#organization","name":"Triga-S Homepage","url":"https:\/\/trigas-trigas-kunden.digitalspital.de\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/trigas-trigas-kunden.digitalspital.de\/#\/schema\/logo\/image\/","url":"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/01\/Triga-S-Logo-Color.webp","contentUrl":"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/01\/Triga-S-Logo-Color.webp","width":1460,"height":369,"caption":"Triga-S Homepage"},"image":{"@id":"https:\/\/trigas-trigas-kunden.digitalspital.de\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/trigas-trigas-kunden.digitalspital.de\/#\/schema\/person\/a224c2f816c9500adb7683c670f0d81c","name":"maria.schaab","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/84ecf33396ba41c0b7cecf4ec639ad2064e7f0e29c951de791ddadde3f5d9155?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/84ecf33396ba41c0b7cecf4ec639ad2064e7f0e29c951de791ddadde3f5d9155?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/84ecf33396ba41c0b7cecf4ec639ad2064e7f0e29c951de791ddadde3f5d9155?s=96&d=mm&r=g","caption":"maria.schaab"},"url":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/author\/maria-schaab\/"}]}},"_links":{"self":[{"href":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/wp-json\/wp\/v2\/posts\/8915","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/wp-json\/wp\/v2\/comments?post=8915"}],"version-history":[{"count":0,"href":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/wp-json\/wp\/v2\/posts\/8915\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/wp-json\/wp\/v2\/media\/8920"}],"wp:attachment":[{"href":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/wp-json\/wp\/v2\/media?parent=8915"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/wp-json\/wp\/v2\/categories?post=8915"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/wp-json\/wp\/v2\/tags?post=8915"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}