Preparing Monitors For Tomorrow's Clinical Trials

By Lauren Garson, Senior Director, Clinical Strategy, Veeva Systems

CRAs have a difficult job – from the extensive travel to the tedious time spent preparing for onsite visits and completing trip reports. For an average phase III trial for large pharma, monitors can spend up to 18 hours on just this task alone. With many top 20 pharma averaging over 40,000 monitoring trip reports per year, it’s not surprising that 25%-30% of total clinical trial costs are attributed to site monitoring.

One way to achieve significant time and cost savings, and increase study quality, is a sound RBM strategy that incorporates quality by design and centralized remote monitoring. Focusing on risks specific to a study’s critical data allows sponsors and CROs to be more productive and allocate resources more effectively. This risk-based approach also conforms with ICH GCP guidelines, enabling faster processes and workflows, and improving study quality.