EU Clinical Trial Regulation | Insights

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The EU CTR replaces the EU Clinical Trials Directive 2001/20/EC and the Voluntary Harmonisation Procedure.</strong></h3> <p> </p> <p>A primary feature of the EU CTR is the introduction of a single electronic portal, the Clinical Trials Information System (CTIS), which is mandatory for all EU CTR submissions effective 31st January 2023. CTIS is the single-entry point for submitting, assessing, authorising, supervising, and reporting a clinical trial in all Member States of the EEA and provides harmonised and simplified end-to-end electronic application procedures over the lifecycle of clinical trials across the EU/EEA.</p> <p>At ICON, we have updated our processes, working practices, and systems to ensure we adhere to the EU CTR and meet the respective timelines. We have optimised our workflows through our understanding of the requirements and the knowledge gained over the past 18 months. Training has been rolled out to all key stakeholders within our organisation, and we continue to work with our sponsors and sites to support their implementation needs. This enables ICON to proactively address challenges and mitigate risks at the time of submissions. To learn more, please <a href="/contact/" target="_self"><strong>contact us</strong></a><strong>.</strong>  </p> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="47dc1b8b-9c10-4d27-bbb7-9724caf48f40"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--text-left-picture-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6 order-sm-2"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/vgo0e4trfg/web/Featured%20Section_1110x678_EU%20whitepaper.jpg?crop=yes&w=1110&h=678&a=0,0&itok=GunqrmLV 1x, https://icon.widen.net/content/vgo0e4trfg/web/Featured%20Section_1110x678_EU%20whitepaper.jpg?crop=yes&w=1110&h=678&a=0,0&itok=GunqrmLV 2x" media="(min-width: 1400px)" width="555" height="339"/> <source 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src="https://icon.widen.net/content/vgo0e4trfg/web/Featured%20Section_1110x678_EU%20whitepaper.jpg" width="1110" height="678" alt="EU whitepaper" title="EU whitepaper" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6 col-sm-pull-6"> <div class="text-picture__text"> <h2></h2> <h3>Demystifying EU CTR, MDR and IVDR</h3> <div><p>Download now and demystify the EU regulation process for medical devices, in vitro diagnostic devices and combined studies.</p></div> <a class="btn btn-primary btn-md" href="/insights/regulatory-intelligence/demystifying-eu-ctr-mdr-and-ivdr" target="_self" title="Read the whitepaper"> Read the whitepaper </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="f047d188-4a84-4c34-82e1-23e5b21dbffa"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--picture-left-text-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/kuinlm5bty/web/ICON_Insights-Articles.png?crop=yes&w=555&h=339&a=0,0&itok=DbNW00lK 1x, https://icon.widen.net/content/kuinlm5bty/web/ICON_Insights-Articles.png?crop=yes&w=555&h=339&a=0,0&itok=DbNW00lK 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/kuinlm5bty/web/ICON_Insights-Articles.png?crop=yes&w=555&h=339&a=0,0&itok=DbNW00lK 1x, https://icon.widen.net/content/kuinlm5bty/web/ICON_Insights-Articles.png?crop=yes&w=555&h=339&a=0,0&itok=DbNW00lK 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/kuinlm5bty/web/ICON_Insights-Articles.png?crop=yes&w=555&h=339&a=0,0&itok=DbNW00lK 1x, https://icon.widen.net/content/kuinlm5bty/web/ICON_Insights-Articles.png?crop=yes&w=555&h=339&a=0,0&itok=DbNW00lK 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/kuinlm5bty/web/ICON_Insights-Articles.png?crop=yes&w=555&h=339&a=0,0&itok=DbNW00lK 1x, https://icon.widen.net/content/kuinlm5bty/web/ICON_Insights-Articles.png?crop=yes&w=555&h=339&a=0,0&itok=DbNW00lK 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/kuinlm5bty/web/ICON_Insights-Articles.png?crop=yes&w=555&h=339&a=0,0&itok=DbNW00lK 1x, https://icon.widen.net/content/kuinlm5bty/web/ICON_Insights-Articles.png?crop=yes&w=555&h=339&a=0,0&itok=DbNW00lK 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/kuinlm5bty/web/ICON_Insights-Articles.png?crop=yes&w=555&h=339&a=0,0&itok=DbNW00lK 1x, https://icon.widen.net/content/kuinlm5bty/web/ICON_Insights-Articles.png?crop=yes&w=555&h=339&a=0,0&itok=DbNW00lK 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/kuinlm5bty/web/ICON_Insights-Articles.png" width="555" height="339" alt="ICON_Insights-Articles" title="ICON_Insights-Articles" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6"> <div class="text-picture__text"> <h2></h2> <h3>Update: EU Clinical Trials Regulation</h3> <div> <p>The European Union Clinical Trials Regulation 536/2014 (EU CTR) introduces fundamental changes for interventional clinical trial submissions and approvals in all 30 countries of the European Union and the European Economic Area. The EU CTR has established a harmonised approach for clinical trial applications, assessment and reporting with consistent rules. Read the <strong>updated</strong> whitepaper to understand the impact and strategic considerations for sponsors as well as experiences and lessons learned since the regulation went into effect.</p> </div> <a class="btn btn-primary btn-md" href="/insights/regulatory/eu-ctr/eu-clinical-trials-regulation" target="_self" title="Read the updated whitepaper"> Read the updated whitepaper </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="fc0fa01c-cbae-4de5-aab0-2680c8c61925"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--text-left-picture-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6 order-sm-2"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=6ilxksZ_ 1x, https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=6ilxksZ_ 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=6ilxksZ_ 1x, https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=6ilxksZ_ 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=6ilxksZ_ 1x, https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=6ilxksZ_ 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=6ilxksZ_ 1x, https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=6ilxksZ_ 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=6ilxksZ_ 1x, https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=6ilxksZ_ 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=6ilxksZ_ 1x, https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=6ilxksZ_ 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg" width="555" height="339" alt="ema-guideline-regulatory" title="ema-guideline-regulatory" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6 col-sm-pull-6"> <div class="text-picture__text"> <h2></h2> <h3>EMA guideline on computerised systems and electronic data in clinical trials</h3> <div> <p>This whitepaper provides an overview of the evolution of the new EMA guideline on computerised systems and electronic data, its scope, and its impact.</p> </div> <a class="btn btn-primary btn-md" href="/insights/regulatory/eu-ctr/ema-guideline-on-computerised-systems-and-electronic-data" target="_self" title="Read the whitepaper"> Read the whitepaper </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="cde68cf0-e542-45fe-8468-3ffc542d3d2d"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--picture-left-text-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/16e8cx8mmj/web/eu-ctr-webinar.jpg?crop=yes&w=555&h=339&a=0,0&itok=cHD_bnH6 1x, https://icon.widen.net/content/16e8cx8mmj/web/eu-ctr-webinar.jpg?crop=yes&w=555&h=339&a=0,0&itok=cHD_bnH6 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/16e8cx8mmj/web/eu-ctr-webinar.jpg?crop=yes&w=555&h=339&a=0,0&itok=cHD_bnH6 1x, https://icon.widen.net/content/16e8cx8mmj/web/eu-ctr-webinar.jpg?crop=yes&w=555&h=339&a=0,0&itok=cHD_bnH6 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/16e8cx8mmj/web/eu-ctr-webinar.jpg?crop=yes&w=555&h=339&a=0,0&itok=cHD_bnH6 1x, https://icon.widen.net/content/16e8cx8mmj/web/eu-ctr-webinar.jpg?crop=yes&w=555&h=339&a=0,0&itok=cHD_bnH6 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/16e8cx8mmj/web/eu-ctr-webinar.jpg?crop=yes&w=555&h=339&a=0,0&itok=cHD_bnH6 1x, https://icon.widen.net/content/16e8cx8mmj/web/eu-ctr-webinar.jpg?crop=yes&w=555&h=339&a=0,0&itok=cHD_bnH6 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/16e8cx8mmj/web/eu-ctr-webinar.jpg?crop=yes&w=555&h=339&a=0,0&itok=cHD_bnH6 1x, https://icon.widen.net/content/16e8cx8mmj/web/eu-ctr-webinar.jpg?crop=yes&w=555&h=339&a=0,0&itok=cHD_bnH6 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/16e8cx8mmj/web/eu-ctr-webinar.jpg?crop=yes&w=555&h=339&a=0,0&itok=cHD_bnH6 1x, https://icon.widen.net/content/16e8cx8mmj/web/eu-ctr-webinar.jpg?crop=yes&w=555&h=339&a=0,0&itok=cHD_bnH6 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/16e8cx8mmj/web/eu-ctr-webinar.jpg" width="555" height="339" alt="eu-ctr-webinar" title="eu-ctr-webinar" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6"> <div class="text-picture__text"> <h2></h2> <h3>Navigating the new EU CTR in early phase clinical trials</h3> <div> <p>During this webinar we outline the EU CTR regulatory review process in Europe– identifying the key differences and implications for your early phase study, outlining the efficiencies achieved within the EU CTR and Netherlands regulatory framework, and submission lessons learned and timeline to approval data based on our experience so far.</p> </div> <a class="btn btn-primary btn-md" href="https://webinars.iconplc.com/detail/videos/clinical-research-services_/video/6328895063112/navigating-the-new-eu-ctr-in-early-phase-clinical-trials?autoStart=true" target="_self" title="Watch the webinar"> Watch the webinar </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="74c51e44-d62f-4d70-b112-09c6cf8bb09d"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--text-left-picture-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6 order-sm-2"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=J8aGFutz 1x, https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=J8aGFutz 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=J8aGFutz 1x, https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=J8aGFutz 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=J8aGFutz 1x, https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=J8aGFutz 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=J8aGFutz 1x, https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=J8aGFutz 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=J8aGFutz 1x, https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=J8aGFutz 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=J8aGFutz 1x, https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=J8aGFutz 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg" width="555" height="339" alt="china-biotechs-insights" title="china-biotechs-insights" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6 col-sm-pull-6"> <div class="text-picture__text"> <h2></h2> <h3>Procedural and regulatory know-how for China biotechs in the EU</h3> <div> <p>In this white paper, ICON’s experts outline potential regulatory strategies and interaction plans for sponsors in China as a guide for marketing authorisation applications in the centralised procedure to the EMA, which allows the marketing authorisation holder to market a drug product in all European Union (EU) Member States, in addition, specific countries in European Economic Area (EEA), with a potential patient pool of approximately 500 million people. </p> </div> <a class="btn btn-primary btn-md" href="/insights/regulatory/procedural-and-regulatory-know-how-for-china" target="_self" title="Read the whitepaper"> Read the whitepaper </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="eb2cbbfa-6b87-43ec-8d72-ed471c9d2819"> <div class="bg-gray"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h2>Latest on Regulatory Intelligence</h2> <h3> </h3> <div> <p>If you would like to receive our regulatory email updates, including the latest on regulatory information please visit our <a href="/preferences/" target="_self">Preference Centre </a>webpage and select <strong>Regulatory Updates</strong> under <strong>Value Based Development</strong>.</p> </div> <a class="btn btn-primary btn-md" href="/preferences" target="_self">Receive Regulatory Intelligence email updates</a> </div> </div> </div> </div> </div> </div> </div> </div> </div><div id="20fa8f95-f258-4baa-94ae-364c729528eb"> <div class="group bg-white"> <div class="container-fluid container-fluid--xl"> <p class="group__text"> </p> <ul class="row card-list"> <li> <a href="https://prod.iconplc.com/insights/blog/2023/10/26/navigating-ctis-setting-clinical-trials-under-eu-ctr" class="block-link" target="_self"> <div class="card card--overlapping-img card--overlapping-img-blue"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/irgl6rdlk6/web/14033%20-%20069%20Navigating%20CTIS%20-%20blog%20Thumbnail_370x194.jpg?crop=yes&w=370&h=194&a=0,0&itok=pYK0uRcN 1x, https://icon.widen.net/content/irgl6rdlk6/web/14033%20-%20069%20Navigating%20CTIS%20-%20blog%20Thumbnail_370x194.jpg?crop=yes&w=370&h=194&a=0,0&itok=nJy6uB7c 2x" media="(min-width: 1400px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/irgl6rdlk6/web/14033%20-%20069%20Navigating%20CTIS%20-%20blog%20Thumbnail_370x194.jpg?crop=yes&w=370&h=194&a=0,0&itok=pYK0uRcN 1x, https://icon.widen.net/content/irgl6rdlk6/web/14033%20-%20069%20Navigating%20CTIS%20-%20blog%20Thumbnail_370x194.jpg?crop=yes&w=370&h=194&a=0,0&itok=nJy6uB7c 2x" media="(min-width: 1200px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/irgl6rdlk6/web/14033%20-%20069%20Navigating%20CTIS%20-%20blog%20Thumbnail_370x194.jpg?crop=yes&w=370&h=194&a=0,0&itok=bfS718-z 1x, https://icon.widen.net/content/irgl6rdlk6/web/14033%20-%20069%20Navigating%20CTIS%20-%20blog%20Thumbnail_370x194.jpg?crop=yes&w=281&h=194&a=45,0&itok=FdP9_Ayc 2x" media="(min-width: 992px) and (max-width: 1199px)" width="301" height="158"/> <source srcset="https://icon.widen.net/content/irgl6rdlk6/web/14033%20-%20069%20Navigating%20CTIS%20-%20blog%20Thumbnail_370x194.jpg?crop=yes&w=370&h=193&a=0,1&itok=0FSfof1f 1x, https://icon.widen.net/content/irgl6rdlk6/web/14033%20-%20069%20Navigating%20CTIS%20-%20blog%20Thumbnail_370x194.jpg?crop=yes&w=370&h=193&a=0,1&itok=soMviiO5 2x" media="(min-width: 768px) and (max-width: 991px)" width="226" height="118"/> <source srcset="https://icon.widen.net/content/irgl6rdlk6/web/14033%20-%20069%20Navigating%20CTIS%20-%20blog%20Thumbnail_370x194.jpg?crop=yes&w=370&h=194&a=0,0&itok=Jm7AYJMS 1x, https://icon.widen.net/content/irgl6rdlk6/web/14033%20-%20069%20Navigating%20CTIS%20-%20blog%20Thumbnail_370x194.jpg?crop=yes&w=370&h=194&a=0,0&itok=eoDB9m8l 2x" media="(min-width: 576px) and (max-width: 767px)" width="400" height="210"/> <source srcset="https://icon.widen.net/content/irgl6rdlk6/web/14033%20-%20069%20Navigating%20CTIS%20-%20blog%20Thumbnail_370x194.jpg?crop=yes&w=370&h=194&a=0,0&itok=wS6cO2Ej 1x, https://icon.widen.net/content/irgl6rdlk6/web/14033%20-%20069%20Navigating%20CTIS%20-%20blog%20Thumbnail_370x194.jpg?crop=yes&w=370&h=194&a=0,0&itok=F6hdJugP 2x" media="(max-width: 575px)" width="400" height="210"/> <img src="https://icon.widen.net/content/irgl6rdlk6/web/14033%20-%20069%20Navigating%20CTIS%20-%20blog%20Thumbnail_370x194.jpg?crop=yes&w=370&h=194&a=0,0&itok=wS6cO2Ej" width="400" height="210" alt="14033 - 069 Navigating CTIS - blog Thumbnail_370x194" title="14033 - 069 Navigating CTIS - blog Thumbnail_370x194" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body overlapping-comp" data-mh="card-body"> <i aria-hidden="true" class="icon-ui-arrow-right"></i> <h4 class="card-title">Blog: Navigating CTIS - Setting up clinical trials under EU CTR</h4> <div class="card-text small"> <div><p>The EU CTR Nº 536/2014 came into force, improving the harmonisation of clinical trials regulation throughout the EU and European Economic Area (EEA).</p></div> </div> </div> </div> </a> </li> <li> <a href="/insights/blog/2023/06/13/eu-ctr-practical-experience" class="block-link" target="_blank"> <div class="card card--overlapping-img text-left card--overlapping-img-blue-light"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/zjmtcqpjuf/web/eu-ctr-lessons-learned.jpg?crop=yes&w=370&h=194&a=0,0&itok=JGBnarUu 1x, https://icon.widen.net/content/zjmtcqpjuf/web/eu-ctr-lessons-learned.jpg?crop=yes&w=370&h=194&a=0,0&itok=wc6LhCLf 2x" media="(min-width: 1400px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/zjmtcqpjuf/web/eu-ctr-lessons-learned.jpg?crop=yes&w=370&h=194&a=0,0&itok=JGBnarUu 1x, https://icon.widen.net/content/zjmtcqpjuf/web/eu-ctr-lessons-learned.jpg?crop=yes&w=370&h=194&a=0,0&itok=wc6LhCLf 2x" media="(min-width: 1200px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/zjmtcqpjuf/web/eu-ctr-lessons-learned.jpg?crop=yes&w=370&h=194&a=0,0&itok=gJ1ZhcnL 1x, https://icon.widen.net/content/zjmtcqpjuf/web/eu-ctr-lessons-learned.jpg?crop=yes&w=281&h=194&a=45,0&itok=m-hnNwiO 2x" media="(min-width: 992px) and (max-width: 1199px)" width="301" height="158"/> <source srcset="https://icon.widen.net/content/zjmtcqpjuf/web/eu-ctr-lessons-learned.jpg?crop=yes&w=370&h=193&a=0,1&itok=Ak-K4zE0 1x, https://icon.widen.net/content/zjmtcqpjuf/web/eu-ctr-lessons-learned.jpg?crop=yes&w=370&h=193&a=0,1&itok=sgZuGYJT 2x" media="(min-width: 768px) and (max-width: 991px)" width="226" height="118"/> <source srcset="https://icon.widen.net/content/zjmtcqpjuf/web/eu-ctr-lessons-learned.jpg?crop=yes&w=370&h=194&a=0,0&itok=XTB9FjLQ 1x, https://icon.widen.net/content/zjmtcqpjuf/web/eu-ctr-lessons-learned.jpg?crop=yes&w=370&h=194&a=0,0&itok=vwrDvH4W 2x" media="(min-width: 576px) and (max-width: 767px)" width="400" height="210"/> <source srcset="https://icon.widen.net/content/zjmtcqpjuf/web/eu-ctr-lessons-learned.jpg?crop=yes&w=370&h=194&a=0,0&itok=1doOceE2 1x, https://icon.widen.net/content/zjmtcqpjuf/web/eu-ctr-lessons-learned.jpg?crop=yes&w=370&h=194&a=0,0&itok=t7pkFwDo 2x" media="(max-width: 575px)" width="400" height="210"/> <img src="https://icon.widen.net/content/zjmtcqpjuf/web/eu-ctr-lessons-learned.jpg?crop=yes&w=370&h=194&a=0,0&itok=1doOceE2" width="400" height="210" alt="eu-ctr-lessons-learned" title="eu-ctr-lessons-learned" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body overlapping-comp" data-mh="card-body"> <i aria-hidden="true" class="icon-ui-arrow-right"></i> <h4 class="card-title">Blog: EU CTR - Practical experiences and lessons learned</h4> <div class="card-text small"> <div> <p>EU CTR insights gained from working with sponsors on a variety of indications, patient populations and investigational product types.</p> </div> </div> </div> </div> </a> </li> <li> <a href="/insights/blog/2023/04/18/the-impact-of-the-new-eu-clinical-trial-regulation" class="block-link" target="_blank"> <div class="card card--overlapping-img text-left card--overlapping-img-blue-light"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source 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