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.
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 contact us.
This whitepaper provides an overview of the evolution of the new EMA guideline on computerised systems and electronic data, its scope, and its impact.Read the whitepaper
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 whitepaper to understand the impact and strategic considerations for sponsors.Read the whitepaper
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.Watch the webinar
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.Read the whitepaper
EU CTR insights gained from working with sponsors on a variety of indications, patient populations and investigational product types.
When it comes to translations, the EU CTR has a significant impact on the requirements for clinical trials conducted in the EU.
The new Clinical Trial Information System allows applicants to submit a single, integrated clinical trial application dossier.