SOURCE: Cutting Edge Information

Cutting Edge Information

December 16, 2014 09:03 ET

Decrease Clinical Trial Budgets With a Risk-Based Monitoring Strategy

Implement During Phase 2 and Phase 3 Trials for Largest Financial Impact

RESEARCH TRIANGLE PARK, NC--(Marketwired - December 16, 2014) - Many life science companies utilize risk-based monitoring (RBM) to reduce costs associated with clinical studies, according to pharmaceutical business intelligence provider Cutting Edge Information. Whereas onsite monitoring comprises up to 60% of clinical trial costs, RBM strategies allow monitors to communicate remotely with well-adjusted clinical sites rather than using valuable man hours to travel for onsite visits. 

The largest potential financial impact comes from longer trials -- often Phase 2 or Phase 3 studies. As the number of site visits decreases, so does the necessary headcount to perform these visits.

"Employing an RBM monitoring strategy will create new expenses like statistical monitoring programs and associated personnel," said Sarah Ray, Senior Research Analyst at Cutting Edge Information. "However, these costs pale in comparison to the savings that arise from reducing onsite monitoring throughout a clinical trial."

Monitors also review only a percentage of source data to verify accuracy, further reducing the time needed to validate site data. Reducing the time necessary to work with each site often means that teams need to employ fewer site monitors or clinical research associates (CRAs) per study, greatly impacting the overall potential trial costs.

"Risk-Based Monitoring: Inject Remote Risk Assessment to Optimize Clinical Trial Outcomes" by Cutting Edge Information provides benchmarks on budgets and staffing for risk assessment teams and RBM activities. The report also includes best practices for implementing RBM strategy and tactics associated with risk-based monitoring usage. The report segments companies' existing use of risk-based monitoring strategy by therapy and trial phase to showcase RBM's role in efficient clinical trial management

The study will help clinical operations executives:

  • Avoid implementing overly complicated RBM techniques
  • Balance existing budget and staffing resources
  • Map out clinical strategy well before trial initialization

To learn more about Cutting Edge Information's research report offerings and CEIConnect subscription services, please visit

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