Exom starts an observational prospective multicenter study to assess the long-term effectiveness and tolerability of a new PCSK9-I inhibitor in the real life clinical practice, in a severe hypercholesterolemic population resistant to full dosage statins.
The study will last for about six year and will enroll 800 patients from 40 selected hospitals.
The most advanced digital solutions will be implemented for the conduction and oversight of this trial, from the eFeasibility to the eTMF and electronic Informed Consent. Moreover the risk for the occurrence of quality and safety issues will be regularly and centrally monitored through the use of the “Risk Based Monitoring platform, Genius RIBAM™.
