Implementing Risk-Based Approaches During Longer Clinical Trials Maximizes Financial Impact

RESEARCH TRIANGLE PARK, NC–(Marketwired – March 29, 2017) – Life science firms look to risk-based monitoring (RBM) to reduce costs associated with clinical studies, according to a study by business intelligence firm Cutting Edge Information.

According to the study, “Risk-Based Monitoring: Inject Remote Risk Assessment to Optimize Clinical Trial Outcomes,” the largest potential for financial impacts come from longer RBM trials — often Phase 2 or Phase 3 studies. Surveyed companies report the greatest savings during Phases 3 and 4 — at an average 21% and 22% total savings, respectively. These data are significantly impacted by an outlier, a device company reporting 80% total savings during Phases 1 and 4 — the highest percentage saved by any company in any development phase.

This device company’s reported savings influence the small and device company average as well as the overall average. Top 10 and Top 50 pharmaceutical companies reveal that their greatest savings occur during Phase 3 (where the longest trials typically happen) at 32%. Surveyed CROs report similar savings during Phases 3 and 4, following the overall trend. These companies average 21% and 23% savings from risk-based monitoring, respectively.

“Employing an RBM 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.”

Whereas on-site monitoring is a significant expense for clinical trials, RBM approaches allow monitors to communicate remotely with well-adjusted clinical sites rather than using valuable man-hours traveling for on-site visits. Reducing the time necessary to work with each site often means that teams need to employ fewer site monitors or CRAs per study, greatly impacting the overall potential trial costs. In longer studies — typically Phase 2 and 3 trials — Cutting Edge Information’s study found that clinical teams can significantly reduce the number of on-site visits and increase the number of sites per monitor. As the number of on-site visits decreases, so does the necessary headcount to perform these visits. However, for short clinical studies, RBM strategies may only reduce on-site monitoring visits by one or two instances — limiting potential savings.

The study, Risk-Based Monitoring: Inject Remote Risk Assessment to Optimize Clinical Trial Outcomes, available at, provides benchmarks on budgets and staffing for risk assessment teams and RBM activities. The report also includes risk-based monitoring best practices amid industrywide trends in a changing clinical monitoring landscape. 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 also includes:

  • Key steps to help implement RBM to help clinical operations executives reduce overall costs by balancing existing budget and staffing resources
  • Strategies to help clinical operations executives avoid implementing overly complicated RBM techniques
  • RBM framework and tactics to allow clinical teams to remotely track sites’ progress during trials and map out clinical strategy well before trial initialization
  • Profiles of company that implement risk-based monitoring tactics

For more information about clinical trials benchmarking research, please visit

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Elio Evangelista
Senior Director of Commercialization
Cutting Edge Information
[email protected]