Taking Advantage Of EMA Clinical Trial Regulations For eCOA Studies In EU

By Bryan McDowell, M.Sc., M.B.A. – VP, eCOA Science and Consulting, and Valdo Arnera, M.D. – Medical Scientific Advisor and General Manager Geneva Office

The EMA Clinical Trials Regulation (CTR), which became effective in late January 2023, aims to streamline and promote extensive clinical trials within the European Union and bolster the quantity of clinical studies conducted in the region. However, in order to achieve the CTR's objective, the industry will need to work together to encourage European EC harmonization.

One way sponsors are looking to save time and effort is by applying for clinical trial authorization once across the EU with the Clinical Trials Information System (CTIS). Learn more about this opportunity to accelerate EC submissions by accessing the full article below.