Cromos Pharma committed to patient centricity in clinical trials Over the last few years, patient centricity has moved from buzzword to an imperative. Sponsors are now increasingly willing to offer a patient centric approach to studies. However, there remains some confusion over what this means and how to implement it. In this article Cromos Pharma looks at some of the strategies that can be
Cromos Pharma explains new EU Medical Device Regulation The EU Medical Device Regulation (Regulation (EU) 2017/745) came into effect on 26 May 2021, following a four-year transition period. From this date manufacturers must comply with the new regulation when bringing new medical devices to market. The legislation aims to improve the safety of medical devices in the EU. A growing market for medical
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
