RADIAL CTIS Part I approved & MHRA Submission done!
Utrecht, 21 July 2022
Very good news: Trials@Home has received approval from the regulators on the CTIS part I submission of the RADIAL trial!
The approval was received on the 18th of July.
This milestone is a true demonstration of where good teamwork within a consortium can lead to!
This was the first step in the formal approval process, where all EU countries in which we want to execute RADIAL have reviewed the protocol. They have shared their comments, which we addressed, and now they have given the green light to proceed with part II of the approval process. CTIS part 2 submission is planned for August.
More good news is that today, 21 July, the initial CTA application to MHRA was also completed.
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 831458. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Notes for editors – not for publication
If you would like more information, please contact the spokesperson at the UMC Utrecht.
Joris Prinssen: +31 6 2571 0234