What will the upcoming Clinical Trial Regulation mean for the conduct of trials in the EU? The long-awaited European Union (EU) Clinical Trial Regulation (Regulation (EU) No 536/2014) (CTR) will come into effect in early 2022. The CTR is intended to improve the submission and review processes for clinical trials via a centralized portal. In recent weeks, the European Medicines Agency (EMA) has confirmed that the clinical trial EU Portal and Database, the
Decentralized Clinical Trials: Are they here to stay? Decentralized clinical trials (DCTs) have been central to the continuation of vital clinical studies throughout the COVID-19 pandemic. Previously the uptake of decentralized models has been slow, but the pandemic changed this. There is now consensus among industry leaders that DCTs are here to stay and may have a central role in advancing research especially
Cromos Pharma’s US BDD on COVID’s impact on clinical research and recover for clinical trials sector It has been over a year and a half since the COVID-19 pandemic hit, causing the deaths of almost 4 million people worldwide[i]. It also precipitated multiple shutdowns of economies and societies around the globe. Many countries, including the US are now well into a recovery phase. As of July 2021, just over 3.25 billion
