How to adapt the ecosystem of clinical trials by adapting the manner of managing risk, in accordance with the recommendations of the EMA for Risk Based Monitoring (R.B.M.)?
Two studies refer to the institutions concerned: OPTIMON (OPTimisation of MONitorage) and ADAMON (ADAptation of MONitorage). OPTIMON makes the observation that clinical monitoring, as it stands, is not optimal. ADAMON (Brosteanu, 2013) is a proposal for a tool that can systematize risk assessment and implementation of targeted measures for the management of clinical data quality by parsimoniously articulating remote monitoring, onsite monitoring and offsite monitoring.
Yannick BARDIE, MSc, PhDf
Professor University of Montpellier and researcher in pharmaceutical safety at Montpellier Research Management