The way clinical trials are conducted in the European Union (EU) will undergo a major change when (EU) No 536/2014 comes into effect in January 2022. This new regulation is binding across all member states.
Intrinsic to the new regulation is the simplification of procedures – with only one submission required vs. up to 31 under the old directive – which are streamlined to remove duplication and delays in launching new clinical studies, the introduction of a lighter regulatory regime for trials conducted with medicines that have already been authorized, and the simplification of reporting requirements.
But just being compliant with the regulation should not be considered enough for any forward-looking organization. The regulation provides sponsors and CROs alike with opportunity to rethink how technology plays an important part in bringing efficiencies to clinical trials, by reducing failures and driving operational changes beyond compliance.