Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Not A Smooth Ride: How One Of The First Studies Navigated The EU Clinical Trial Portal

Executive Summary

From grappling with a never-ending list of conflicting national requirements to dealing with numerous technical issues, a research project manager at Norway’s Oslo University Hospital talks about the hiccups faced by their multinational COVID-19 platform trial that was among the first studies submitted for approval under the EU Clinical Trial Regulation.

You may also be interested in...



Centralized Templates To Help Harmonize Trial Dossiers Requirements Across The EU

Following feedback from its clinical trials expert group, the European Commission has published new and updated templates that sponsors can use to prepare study applications that would be acceptable in all the EU member states.

Straightforward But Technical: Transferring Existing Studies To EU Clinical Trial Portal

At a webinar organized by the European Medicines Agency, EU member states discussed their experiences with reviewing the requests made by trial sponsors to switch existing studies to the Clinical Trial Regulation.

EU Offers Advice On Running Complex Clinical Trials Under CTR

New EU-wide guidance describes the factors that sponsors should consider when designing and conducting trials with complex innovative designs. 

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS146805

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel