Since 1996 ICH-GCP has proven to regulators considerable advances in technology. Monitoring and identifying risk has justified all efforts to accomplish safety and compliance of clinical trials, which makes it both beneficial- pharma industry and patients.
Looking at the future of the clinical research world, TransCelerate Biopharma Inc., an independent non-profit organization focused on accelerating the development of new medicines and solving fundamental issues pharmaceutical companies face in bringing new therapeutics to market, believes that their Risk-Based Monitoring (RBM) methodology will have significant impact on clinical trial site monitoring efficiencies. They have just submitted a second update on their manual and their are back to us with a brand new Risk-Based-Monitoring training. You can find it online and it is completely free: