Mitigating the Challenges of Clinical Trial Monitoring: A Technology- | Page 6

Scheduling on-site monitoring visits based on elapsed time (every 4 or 6-weeks) leads to less efficient deployment of resources than Just-in-Time monitoring Example Study: 20 sites, 138 subjects, active enrollment period of 8 months with 1 month of treatment/follow-up Takeaway: With JIT monitoring, you’re no longer over-monitoring low-enrolling sites, but focusing on high-enrolling sites (those most likely to be audited) 70.0 Hours per Subject (Q6) Hours per Subject (JIT) 50.0 20 Subjects Enrolled 15 40.0 30.0 10 20.0 Number of Subjects 60.0 Monitoring Hours per Subject 25 Hours per Subject (Q4) 5 10.0 0.0 3 1 5 Total Monitoring Hours 9 9% 11 Site Number 13 15 17 19 0 { 36% Hours Required On-Site 7 Maximizing Efficiency: Saving Time and Costs » Q4 Wk Optimize Site Visits and Productivity. Digital trial technology enables optimal use of resources, deploying the minimally effective number of Q6 Wk individuals for trial monitoring and management. Since a considerable amount of data collection and trial oversight can be done remotely, JIT greater reliance on technology enhances productivity while reducing 0 500 1000 1500 Hours 2000 2500 3000 site visits and travel costs. The technology has changed the paradigm for monitoring visit frequency from an elapsed duration, such as every clinipace.com 5