CTR/CTIS

CTR/CTIS · 22. April 2024

Transparency Rules Changes in CTIS Submissions: A Guide for Sponsors and CRO Colleagues

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

Been There, Done That: A Regulatory Affairs Pro Navigates the New EU Clinical Trial Landscape

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.

CTR/CTIS · 19. March 2024

Substantial Modifications in Your EU Clinical Trial: A Resource Guide

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 Latest EU Clinical Trial Guidances: A Detailed Look (March 2024 Update)

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.

CTR/CTIS · 22. February 2024

Navigating the Transition: Ensuring Compliance with the Clinical Trials Regulation (CTR)

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

The EU Clinical Trial Regulation: A Streamlined Guide for Sponsors & CROs

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.