Cromos Pharma on rare disease drug development An estimated 475 million people are affected by rare disease worldwide (WEFORUM), and only 5% of people with a rare disease have a treatment. This represents a significant unmet medical need. Rare disease clinical trials involve challenges above and beyond those encountered for large scale clinical studies for more common diseases. Operational and scientific challenges include: Limited pool
Reaping the benefits of eCONSENT for clinical trials Clinical research is made possible because patient volunteers give their consent to participate in clinical trials. Informed consent is an essential part of enrolling patients in a clinical trial. Through the consent process a potential participant receives all the information they need about their role in the clinical trial. eCONSENT While in the past consent was acquired
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
