FAMHP organises two information sessions to provide all sponsors and applicants for clinical trials with as much information as possible about the new Regulation. BeCRO is actively involved in the organisation of these workshops. The first information session took place on 23 September 2021.During this session, an update was given on the different aspects of the […]

EMA’s Management Board confirmed that the clinical trial EU Portal and Database, one of the main deliverables of the Clinical Trial Regulation and the key component of the Clinical Trial Information System (CTIS), is now fully functional and on track to go live by 31 January 2022. The Board confirmed that it has verified that the system meets the agreed requirements during an extraordinary […]

The latest update to the European Commission and European Medicines Agency’s guidance on managing clinical trials conducted during the COVID-19 pandemic (V4 04Feb21) expands the use and scope of remote source data verification (rSDV) in clinical trials. Now, in addition to trials involving the treatment or prevention of COVID-19, remote SDV may be considered for […]