With the upcoming application of the new EU Clinical Trials Regulation (‘CTR’), the conduct of clinical trials in the European Union (‘EU’) will soon undergo a major change. From 31 January 2022, the CTR will standardise the procedures for conducting clinical trials throughout the EU, introducing a single Clinical Trials Information System (‘CTIS’) as well as other key variations to the regulatory framework established by the 2001 Clinical Trials Directive (‘CTD’). As the CTR application date approaches, this report provides an overview of the main changes brought by the new regulation which pharmaceutical companies sponsoring clinical trials in the EU and other stakeholders should be aware of. 

Read the full report here and for further information, please get in touch.