So Far So Good: EU Member States On ‘Limited’ Experience With Clinical Trial Portal
At a recent webinar on the EU Clinical Trial Information System (CTIS), representatives from different EU member states said the new system was working well and highlighted certain “good practices” for study sponsors to consider.
You may also be interested in...
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.
Notably more clinical trial applications were submitted to the new Clinical Trial Information System in July compared with previous months, according to new data that also shed light on how many submissions have been approved or rejected.
A senior European Commission official has a clear answer for those expecting the mandatory phase of the EU Clinical Trial Regulation to be delayed. There is no such plan on the cards.