CTR/CTIS · 22. April 2024
EMA has set 18 June 2024 as the go-live date for revised transparency rules in CTIS, prioritising transparency, protecting confidential information, and limiting public access to certain documents. This shift aims to streamline processes, reduce administrative burdens, and enhance operational efficiency, benefiting sponsors, CROs, and patients alike.
CTR/CTIS · 08. April 2024
The EU's new Clinical Trials Regulation (CTR) and CTIS portal bring fresh changes to the clinical trial landscape. This blog post, aimed at Regulatory Affairs professionals, explores the similarities to the past CTD implementation and the new complexities introduced by CTIS.
Clinical Trials · 22. March 2024
This blog post examines key takeaways from the February 2024 CTAG meeting for Regulatory Affairs and Study Start-Up professionals. The focus is on proposed changes to streamline applications for substantial modifications and adding new EU member states to trials. Additionally, the post explores resources to aid sponsors transitioning from the Clinical Trials Directive to the CTR.
Clinical Trials · 21. March 2024
European clinical trials have their own set of regulations. The Clinical Trial Coordination and Advisory Group (CTAG) plays a key role in shaping these regulations. This post explores CTAG's function and its impact on clinical trials in Europe.
CTR/CTIS · 19. March 2024
Substantial changes (SMs) to your linical trial require a formal process. This blog post highlights the Dutch CCMO templates, to help you navigate SMs.
CTR/CTIS · 12. March 2024
The Europen Commission just updated key clinical trial guidance documents (March 2024) in EudraLex Vol 10. Here's what you need to know for compliance.
Clinical Trials · 05. March 2024
The updated recommendations endorsed by the CTAG in March 2024 provide comprehensive guidance for stakeholders navigating the utilization of Auxiliary Medicinal Products (AxMPs) in clinical trials, ensuring adherence to evolving regulatory standards, particularly the Clinical Trials Regulation (CTR EU 536/2014).
CTR/CTIS · 22. February 2024
Dive into Mat Parowicz's latest blog article as he discusses the urgent transition to compliance with the Clinical Trials Regulation (CTR). Explore the importance of timely action, preparation, and expert guidance for sponsors and CROs navigating this transformative period in clinical trials regulation.
CTR/CTIS · 28. January 2024
New EU Clinical Trial Regulation (CTR) got you lost? We've got you covered! This guide breaks down key changes for sponsors & CROs. The CTR simplifies approvals, strengthens transparency & safeguards participants. Master the CTIS application platform & stricter reporting requirements.