More Tools & Data Sources: More Insights for RBM?

Risk-based monitoring (RBM) was codified into clinical research by the November 2016 Integrated Addendum to the ICH GCP Guideline (E6[R2]). Many organizations now face challenges in implementing RBM in an R&D environment which is simultaneously (and increasingly) impacted by machine learning and artificial intelligence. “Process automation has advanced to make large numbers of tasks ‘invisible,’ ‘behind the scenes’ in the computer and that leaves only the tasks that matter most available for us as humans to execute,” explains Gregg Larson, Vice President of Clinical Operations at Ultragenyx Pharmaceutical, Inc. “Technology has not yet evolved to the point of thinking for humans. We still have to do the thinking.”