Data transparency: Why it’s important to post trial results on EudraCT or CTIS

While there is much focus on transparency in the Clinical Trial Regulation, it’s important that sponsors understand their data transparency obligations for trials that were conducted in the EU and that will be wrapped up under the Clinical Trial Directive. Sponsors are expected to ensure results from those studies that do not need to transition […]

Allowing time for the legal rep evaluation in the move to CTR

The Clinical Trials Regulation (CTR) has added some complexities for non-EU sponsors, including with regard to the role of the legal representative. Sponsors who are not based in the EU must appoint a representative within the EU to act as a legal representative. While this has always been a requirement, under the CTR the legal […]

Understanding what’s required to work in CTIS

Before making a submission to the CTIS, sponsors transitioning clinical trials previously approved under the EU Clinical Trials Directive must take several preparatory steps. These can be time consuming and are not always well-understood so it’s important that you take time to prepare yourself before making the transition. To get started, you will need to […]

The multiple steps involved in the transition to CTR

There is a lot for sponsors to think about before they can even start transitioning their clinical trials to the Clinical Trial Regulation (CTR) and accessing the various portals. First, there are practicalities of how they will manage their ongoing studies to ensure they are suitable to transition to CTR. While this is something most […]