{"id":7143,"date":"2025-09-18T16:34:17","date_gmt":"2025-09-18T16:34:17","guid":{"rendered":"https:\/\/mdxcro.com\/?post_type=service&#038;p=7143"},"modified":"2026-04-16T08:19:51","modified_gmt":"2026-04-16T08:19:51","slug":"ivd-clinical-studies","status":"publish","type":"service","link":"https:\/\/mdxcro.com\/fr\/services\/ivd-clinical-studies\/","title":{"rendered":"IVD Clinical Studies"},"content":{"rendered":"\n<section id=\"block_3c1f1e69f245a3b2ea88834827e811b8\" class=\"hero\">\n    <div class=\"hero--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/04\/sectors-MDx-CRO.webp\" fetchpriority=\"high\" class=\"no-lazy\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">IVD Clinical Performance Studies: End-to-End CRO Services for IVDR Compliance<\/h1>\n            \n                            <div class=\"description\"><p>MDx is a specialized IVD CRO (Contract Research Organization) providing expert-led clinical performance evaluation for IVDR, FDA, and global markets. Our IVD clinical studies services include comprehensive protocol development, site management, ethics committee submissions, and regulatory documentation.<\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"https:\/\/mdxcro.com\/contact\/?utm_source=ivd_clinical_studies\" class=\"button button--default\" target=\"_self\">\n                            Book a Discovery Call                        <\/a>\n                                            <a href=\"https:\/\/mdxcro.com\/running-clinical-studies-under-ivdr-what-you-need-to-know\/\" class=\"button button--secondary\" target=\"_self\">\n                            Read Our Clinical Study Guide                        <\/a>\n                                    <\/div>\n                            <\/div>\n            <\/div>\n<\/section>\n\n\n\n<section id=\"block_1a062af725d36cb618c22171085f9feb\" class=\"text-image text-image--video-player\" style=\"\">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Why IVD Clinical Studies Matter<\/h2><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\"><strong>Successful IVD clinical performance studies are critical for <span class=\"blue-highlight\"> market access <\/span> under IVDR, FDA, and global regulatory frameworks.<\/strong> <\/span><\/p>\n<p><span style=\"font-weight: 400\">Whether you&rsquo;re developing a high-risk Class D assay, a companion diagnostic <strong><span class=\"blue-highlight\"> (CDx) <\/span><\/strong>, or transitioning from IVDD to IVDR, MDx CRO ensures your clinical evidence meets regulatory expectations through rigorous clinical performance evaluation and strategic study design.<\/span><\/p>\n<p><span style=\"font-weight: 400\">Our team delivers <strong><span class=\"blue-highlight\"> end-to-end clinical study solutions <\/span><\/strong>-from IVDR Annex XIII\/XIV submissions and clinical performance study protocols (CPSP) to site management, ethics committee approvals, and final clinical performance reports. With expertise in ISO 20916 and IVDR compliance, we ensure your IVD receives timely approval with robust clinical evidence. <\/span><\/p>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><div class=\"video-player video-player--youtube\" data-youtube-url=\"https:\/\/www.youtube.com\/embed\/nKpFU7PGN5U?si=NIs7BU6aOYXYixgu\"><div class=\"youtube-container\"><div class=\"youtube-poster\"><img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/What-is-a-Clinical-Performance-Study-under-IVDR-2.jpg\" alt=\"Video Poster\" \/><button class=\"play-btn youtube-play-btn\"><\/button><\/div><div class=\"youtube-iframe-container\" style=\"display: none\"><!-- Iframe will be created here dynamically --><\/div><\/div><\/div><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"block_b328de7ccdd72f72489bda4e2f976347\" class=\"flip-cards flip-cards--three-columns flip-cards--grayscale \" style=\"padding-top: var(--wp--preset--spacing--regular); padding-bottom: var(--wp--preset--spacing--regular); \">\n            <div class=\"container\">\n        <div class=\"content\">\n            \n                            <h2 class=\"title\">Full-Service Clinical Study Design &#038; Execution<\/h2>\n            \n                            <div class=\"teaser wysiwyg\"><p>MDx delivers end-to-end IVD clinical performance services, managing every phase of your study lifecycle:<\/p>\n<\/div>\n            \n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--background-white card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">1.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Planning &amp; Strategy<\/div>\n                        <div class=\"back\"><ul>\n<li>IVDR clinical strategy and pathway<\/li>\n<li>Clinical performance study design (CPSP)<\/li>\n<li>Feasibility and study risk assessment<\/li>\n<li>ISO 20916-aligned planning and timelines<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">2.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Documentation &amp; Submissions<\/div>\n                        <div class=\"back\"><ul>\n<li>CPSP development<\/li>\n<li>Annex XIII\/XIV evidence planning and alignmen<\/li>\n<li>Ethics Committee \/ IRB submissions and packages<\/li>\n<li>Competent Authority documentation and interactions<\/li>\n<li>Investigator\u2019s Brochure creation<\/li>\n<li>EUDAMED performance study notifications<\/li>\n<li>TMF setup and maintenance<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">3.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Site Management &amp; Execution<\/div>\n                        <div class=\"back\"><ul>\n<li>Site and lab selection, qualification, and initiation<\/li>\n<li>Investigator training and site initiation visits<\/li>\n<li>Clinical monitoring (on-site and remote) to ISO 20916<\/li>\n<li>Biological sample logistics and accountability<\/li>\n<li>CRF\/eCRF design, build, and implementation<\/li>\n<li>Protocol adherence oversight and issue resolution<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">4.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Data Management &amp; Reporting<\/div>\n                        <div class=\"back\"><ul>\n<li>eCRF design and validation; data capture and QC<\/li>\n<li>Statistical analysis plan development and execution<\/li>\n<li>Clinical performance reports; final clinical evidence packages<\/li>\n<li>Device deficiencies tracking and reconciliation<\/li>\n<li>TMF completeness checks and close-out<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">5.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Regulatory Affairs, Safety &amp; Representation<\/div>\n                        <div class=\"back\"><ul>\n<li>Adverse event monitoring and safety reporting for performance studies<\/li>\n<li>Ongoing regulatory authority communications<\/li>\n<li>Coordination with Notified Bodies<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">6.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Global Representation<\/div>\n                        <div class=\"back\"><ul>\n<li>EU Legal Representative for non-EU sponsors;<\/li>\n<li>UK RP for non-UK sponsors<\/li>\n<li>Multi-country study harmonization<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section>\n\n\n<section id=\"block_37b61b210b09b17711d410864bf4c174\" class=\"text-image\" style=\"padding-bottom: var(--wp--preset--spacing--regular); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Regulatory Alignment<\/h2><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\">MDx ensures your IVD clinical studies comply with all relevant regulations:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>IVDR 2017\/746<\/b><span style=\"font-weight: 400\"> &#8211; Annex XIII, Annex XIV, Article 58, 61-69<\/span><\/li>\n<li style=\"font-weight: 400\"><b>ISO 20916:2024<\/b><span style=\"font-weight: 400\"> &#8211; Clinical performance studies for IVDs<\/span><\/li>\n<li style=\"font-weight: 400\"><b>FDA requirements<\/b><span style=\"font-weight: 400\"> for IVD clinical studies<\/span><\/li>\n<li style=\"font-weight: 400\"><b>ISO 14155<\/b><span style=\"font-weight: 400\"> principles where applicable<\/span><\/li>\n<li style=\"font-weight: 400\"><b>GCP principles<\/b><span style=\"font-weight: 400\"> adapted for IVD performance studies<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Local ethics committee<\/b><span style=\"font-weight: 400\"> requirements<\/span><\/li>\n<li style=\"font-weight: 400\"><b>National Competent Authority <\/b><span style=\"font-weight: 400\">requirements<\/span><\/li>\n<\/ul>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/scientific-validity-scaled.jpeg\" alt=\"Advanced medical data analysis using digital dashboards in a modern laboratory environment.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"block_22625113fda5f25aa5c4501b87f36c19\" class=\"content-columns content-columns--four-columns \" style=\"\">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">Study Types We Support<\/h2>\n                                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Clinical Performance Studies<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><p><span style=\"font-weight: 400\">Diagnostic sensitivity, specificity, PPV, NPV, PPA, NPA, clinical utility<\/span><\/p>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-black\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Scientific (peer-reviewed) literature<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><p><span style=\"font-weight: 400\">Literature-based evidence generation<\/span><\/p>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-blue\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Data based on routine diagnostic testing<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><p><span style=\"font-weight: 400\">EQA and published clinical data<\/span><\/p>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Post-Market Performance Follow-up (PMPF)<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><p><span style=\"font-weight: 400\">Continuous evidence collection<\/span><\/p>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-blue\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Performance Evaluation<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><p><a href=\"https:\/\/mdxcro.com\/fr\/services\/ivd-analytical-studies\/\"><span style=\"font-weight: 400\">Analytical<\/span><\/a><span style=\"font-weight: 400\"> and clinical data integration<\/span><\/p>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Companion Diagnostic (CDx) Studies<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><p><a href=\"https:\/\/mdxcro.com\/fr\/services\/precision-medicine-companion-diagnostics\/\"><span style=\"font-weight: 400\">Precision medicine<\/span><\/a><span style=\"font-weight: 400\"> assay validation<\/span><\/p>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-black\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Method Comparison Studies<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><p><span style=\"font-weight: 400\">Against established reference methods<\/span><\/p>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n\n\n<section class=\"table\"><div class=\"container\"><div class=\"headline\">Our clinical team has extensive experience across diagnostic platforms<\/div><div class=\"table-wrapper\"><div class=\"feature-column-wrapper\"><table class=\"feature-table\"><thead><tr><th class=\"feature-column\">Technology<\/th><\/tr><\/thead><tbody><tr><td class=\"feature-cell\"><strong>Molecular Diagnostics<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Immunoassays<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Histopathology<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Point-of-Care<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Software &amp; AI<\/strong><\/td><\/tr><\/tbody><\/table><\/div><div class=\"scrollable-columns-wrapper\"><table class=\"comparison-table\"><thead><tr><th class=\"column highlight\">Applications<\/th><\/tr><\/thead><tbody><tr><td class=\"cell highlight\">PCR, qPCR, digital PCR, NGS panels<\/td><\/tr><tr><td class=\"cell highlight\">ELISA, chemiluminescence, multiplex<\/td><\/tr><tr><td class=\"cell highlight\">IHC, ISH, digital pathology<\/td><\/tr><tr><td class=\"cell highlight\">Lateral flow, microfluidics, biosensors<\/td><\/tr><tr><td class=\"cell highlight\">Algorithm validation, SaMD, digital diagnostics<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n\n\n<section class=\"key-stats\"  style=\"\">\n    <div class=\"container\">\n          <div class=\"headline\">Results That Matter<\/div>\n    \n    <div class=\"main-wrapper\">\n              <div class=\"box-grid\">\n                                    <div class=\"box\">\n                                  <div class=\"value\">100+<\/div>\n                                                  <div class=\"legend\">IVD clinical performance studies designed <\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">60+<\/div>\n                                                  <div class=\"legend\">performance study submissions in multi-country trials<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">400+<\/div>\n                                                  <div class=\"legend\">essential study documents developed<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">30+ <\/div>\n                                                  <div class=\"legend\">IVDR studies across oncology, infectious diseases, and more<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">100%<\/div>\n                                                  <div class=\"legend\">success rate in performance study submissions<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">9.4\/10<\/div>\n                                                  <div class=\"legend\">client satisfaction rating<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">14<\/div>\n                                                  <div class=\"legend\">EU languages spoken by our team<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">20+<\/div>\n                                                  <div class=\"legend\">countries including EU\/US<\/div>\n                              <\/div>\n                              <\/div>\n      \n          <\/div>\n\n    <div class=\"data\">\n      \n          <\/div>\n  <\/div>\n<\/section>\n\n\n<section class=\"table\"><div class=\"container\"><div class=\"table-wrapper\"><div class=\"feature-column-wrapper\"><table class=\"feature-table\"><thead><tr><th class=\"feature-column\">Capability<\/th><\/tr><\/thead><tbody><tr><td class=\"feature-cell\"><strong>ISO 20916 Study Design<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>IVDR Clinical Evidence Expertise<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Ethics Committee &amp; CA Submissions<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Performance Study Monitoring<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Legal Representation in EU<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>IVD-Specific Documentation<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>EUDAMED Registration<\/strong><\/td><\/tr><\/tbody><\/table><\/div><div class=\"scrollable-columns-wrapper\"><table class=\"comparison-table\"><thead><tr><th class=\"column highlight\">MDx CRO<\/th><th class=\"column\">Other CROs<\/th><\/tr><\/thead><tbody><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Specialized expertise<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Limited experience<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Former NB\/CA experts<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Often lacking<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">100% success rate<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Variable experience<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">IVD-specialized monitors<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Often pharma-focused<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Full service available<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Rarely offered<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">CPSP, performance reports<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Generic templates<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Complete support<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Limited guidance<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n\n\n<section id=\"block_7d7752114ce9124fb76c035b6bb06f66\" class=\"testimonials\" style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/design-sponsor.jpg&#039;);\">\n        <div class=\"testimonials--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/design-sponsor.jpg\" \/>\n    <\/div>\n    <div class=\"container\">\n                    <div class=\"headline\">Client Testimonial<\/div>\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0Delegating device sponsor responsibilities to MDx significantly improved our clinical trial operations. It allowed us to streamline our studies, ensuring fast study approvals in several countries and compliance with ISO 20916. Their team&rsquo;s ability to fill our internal knowledge gap on deviceregulations was invaluable.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Senior Director, Clinical Projects                                                                <br>\n                                Top 10 Global IVD Manufacturer                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0MDx guided us through our first European performance study. Their knowledge of ISO 20916 requirements and their support with site training gave us confidence that nothing was overlooked.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Clinical Operations Manager                                                                <br>\n                                Mid-Size Molecular Diagnostics Company                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0What stood out was your responsiveness. Whenever questions came from investigators or regulators, MDx provided clear answers quickly. It kept our study on schedule and reduced stress for our team.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Head of Regulatory Affairs                                                                 <br>\n                                Specialty Diagnostics Firm                                        \n                            <\/p>\n                                            <\/div>\n                            <\/div>\n        \n        <div class=\"footer\">\n            <div class=\"slider-dots\"><\/div>\n            <div class=\"button-wrapper\">\n                            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"block_221e80d9392ade0f1c873e0f7853c78e\" class=\"faqs\" style=\"\">\n    <div class=\"container\">\n    <div class=\"content\">\n      <div class=\"column\">\n                  <h2 class=\"headline\">Frequently Asked Questions<\/h2>\n                          <a class=\"button button--default\" href=\"https:\/\/mdxcro.com\/contact\/?utm_content=service_ivd_clinical_studies\" target=\"\">\n            Ask us a Question          <\/a>\n              <\/div>\n      <div class=\"column\">\n                  <ul class=\"faq-list\">\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">What is the difference between a clinical trial and an IVD performance study?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">While both evaluate device performance, IVD performance studies follow specific regulations (IVDR, ISO 20916) rather than traditional clinical trial frameworks (ICH-GCP). IVD studies typically focus on evaluating an assay&rsquo;s clinical performance using existing or newly collected samples, rather than testing interventions on patients.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Can MDx handle ethics committee and competent authority submissions?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Yes, we manage all aspects of ethics committee (EC\/IRB) submissions and competent authority applications. Our team has a 100% success rate in obtaining approvals across multiple European countries for IVDR performance studies.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Does MDx offer legal representation for IVD clinical studies in Europe?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Yes, we provide full legal representation services for non-EU sponsors conducting studies under IVDR Article 58. This includes handling all regulatory communications, safety reporting, and compliance responsibilities.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\"> What is a CPSP under IVDR?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">A Clinical Performance Study Protocol (CPSP) is a mandatory document for IVD performance studies under IVDR. It details study design, objectives, participant selection, sample handling, statistical analysis, and quality procedures in compliance with ISO 20916 and IVDR Annex XIII\/XIV requirements.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">How does MDx handle safety reporting in IVD performance studies?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">We implement robust systems for monitoring and reporting adverse events and device deficiencies according to IVDR requirements, with clear escalation pathways, reporting timelines, and documentation procedures.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Can you support multi-country IVD studies?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Absolutely. We have extensive experience coordinating studies across multiple countries, harmonizing submissions, and managing site networks throughout Europe, North America, and APAC.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">What is an IVD CRO?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>An IVD CRO (In Vitro Diagnostics Contract Research Organization) is a specialized service provider that supports companies in developing, validating, and bringing diagnostic tests to market, tests that are performed on samples like blood or tissue outside the human body. These organizations help with <a href=\"https:\/\/mdxcro.com\/fr\/services\/clinical-research\/\">clinical research<\/a>, clinical studies, regulatory compliance (such as approvals from authorities like the <span class=\"hover:entity-accent entity-underline inline cursor-pointer align-baseline\"><span class=\"whitespace-normal\">FDA<\/span><\/span> or <span class=\"hover:entity-accent entity-underline inline cursor-pointer align-baseline\"><span class=\"whitespace-normal\">European Medicines Agency<\/span><\/span>), performance evaluation, and quality assurance. In simple terms, an IVD CRO acts as an external expert partner that guides diagnostic companies through the complex process of proving their tests are safe, accurate, and ready for commercial use.<\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                      <\/ul>\n              <\/div>\n    <\/div>\n  <\/div>\n<\/section>\n\n  <script type=\"application\/ld+json\">\n    {\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"What is the difference between a clinical trial and an IVD performance study?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"While both evaluate device performance, IVD performance studies follow specific regulations (IVDR, ISO 20916) rather than traditional clinical trial frameworks (ICH-GCP). 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We have extensive experience coordinating studies across multiple countries, harmonizing submissions, and managing site networks throughout Europe, North America, and APAC.\"}},{\"@type\":\"Question\",\"name\":\"What is an IVD CRO?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"An IVD CRO (In Vitro Diagnostics Contract Research Organization) is a specialized service provider that supports companies in developing, validating, and bringing diagnostic tests to market, tests that are performed on samples like blood or tissue outside the human body. These organizations help with clinical research, clinical studies, regulatory compliance (such as approvals from authorities like the FDA or European Medicines Agency), performance evaluation, and quality assurance. In simple terms, an IVD CRO acts as an external expert partner that guides diagnostic companies through the complex process of proving their tests are safe, accurate, and ready for commercial use.\"}}]}  <\/script>\n\n\n\n<section id=\"block_7fbb5cf339f130838bb39fb551bba45a\" class=\"call-to-action\" style=\"\">\n        <div class=\"call-to-action--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/mdx-cta-bg.png\" \/>\n    <\/div>\n    <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"content\">\n                                    <h2 class=\"title\">Partner with Europe&#039;s Leading IVD CRO Clinical Study Experts<\/h2>\n                \n                                    <div class=\"description wysiwyg\">\n                        <p><span style=\"font-weight: 400;\">Whether you&rsquo;re planning your first IVDR performance study or managing a global clinical evaluation program, MDx delivers the expertise, resources, and regulatory knowledge to ensure success.<\/span><\/p>\n<p><b>From Protocol to Performance Report. We Deliver.<\/b><\/p>\n                    <\/div>\n                            <\/div>\n\n                            <div class=\"button-wrapper\">\n                                                                        <a href=\"https:\/\/mdxcro.com\/contact\/?utm_content=service_ivd_clinical_studies\" class=\"button button--secondary\" target=\"\">\n                                Contact us                            <\/a>\n                                                                                                <a href=\"https:\/\/mdxcro.com\/running-clinical-studies-under-ivdr-what-you-need-to-know\/\" class=\"button button--tertiary\" target=\"\">\n                                Read Our Clinical Study Guide                            <\/a>\n                                                            <\/div>\n                    <\/div>\n    <\/div>\n<\/section>\n\n\n\n<script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"Service\",\n  \"serviceType\": \"IVD Clinical Studies and Performance Evaluation\",\n  \"provider\": {\n    \"@type\": \"Organization\",\n    \"name\": \"MDx CRO\",\n    \"url\": \"https:\/\/www.mdxcro.com\",\n    \"logo\": \"https:\/\/www.mdxcro.com\/wp-content\/uploads\/logo.png\",\n    \"description\": \"European CRO specializing in IVD and medical device regulatory consulting\"\n  },\n  \"areaServed\": [\n    {\n      \"@type\": \"Place\",\n      \"name\": \"European Union\"\n    },\n    {\n      \"@type\": \"Place\", \n      \"name\": \"United States\"\n    },\n    {\n      \"@type\": \"Place\",\n      \"name\": \"Asia\"\n    }\n  ],\n  \"description\": \"Comprehensive IVD clinical studies services including performance evaluation, analytical validation, and clinical evidence generation for IVDR compliance and market access in Europe.\",\n  \"hasOfferCatalog\": {\n    \"@type\": \"OfferCatalog\",\n    \"name\": \"IVD Clinical Studies Services\",\n    \"itemListElement\": [\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"IVDR Performance Evaluation\"\n        }\n      },\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"Clinical Evidence Generation\"\n        }\n      },\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"Analytical Validation Studies\"\n        }\n      }\n    ]\n  }\n}\n<\/script>\n","protected":false},"featured_media":0,"parent":0,"menu_order":0,"template":"","meta":{"_acf_changed":true},"class_list":["post-7143","service","type-service","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>IVD CRO Services: IVDR Clinical Performance Studies | MDx CRO<\/title>\n<meta name=\"description\" content=\"MDx CRO delivers end-to-end IVD clinical performance studies under IVDR and ISO 20916. 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