What Is All the Uproar About Risk?

By Gayle Hamilton, Director, RBQM, Digital Trial Management Suite

A few questions to ponder… Do you feel like your trial will be more at risk if you cut out 100% SDV or CRAs visiting sites every 6 weeks? What if we don't catch missed adverse events or something more important? SAEs, Quality Issues? Are there higher risks with the risk-based approach? Well… what if the system you were using automates the data with traceability well enough that these potential issues are mitigated?