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Chris Moore shares top tips for US biotechs setting up clinical studies in Europe

clinical studiesAn article authored by Chris Moore, Clinical Project Manager at Boyds, has been featured by Clinical Leader.

The piece: ‘Top 10 considerations for US biotechs setting up clinical studies in Europe’ outlines important items for US companies to consider, particularly in light of the EU’s implementation of the Clinical Trial Regulation (CTR) and the set-up of the Clinical Trial Information System (CTIS) for the submission of combined Clinical Trial Applications (CTA) to EU countries.

Any company that currently has a trial running in Europe under the Clinical Trial Directive (CTD) has until 30 January 2025 to transfer the study from CTD to CTR. If sponsors complete the CTR transition before 16 October 2024, they can submit their currently approved package, and the EMA will review it within the expedited 22 days. After this date, the standard timelines for review will apply.

Click here to read the full article on Clinical Leader.

For further advice or support, get in touch with the Boyds clinical and medical affairs team.

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