SOURCE: Cutting Edge Information

Cutting Edge Information

July 14, 2015 08:30 ET

Prepare Risk-Based Monitoring Plans Five Months Ahead of Clinical Trial Initiation, Suggests Cutting Edge Information

RESEARCH TRIANGLE PARK, NC--(Marketwired - July 14, 2015) - Risk-based monitoring (RBM) represents an extension and, at times, sophistication of existing trial monitoring techniques. According to primary intelligence provider Cutting Edge Information, companies construct RBM plans that outline the extent to which teams intend to implement statistical methods, trial technologies and other tools to assess, monitor and reduce trial risk.

As part of their RBM approach, teams may reduce the amount of source data verification (SDV) they perform. Others may also construct clinical thresholds that -- if surpassed -- signal the need for sponsor or contract research organization (CRO) teams to follow up with specific research sites.

Often, RBM plans cater to the needs of individual clinical studies. A reduced monitoring approach, for example, may be a better fit for studies with relatively non-complex or low-risk protocols. "Clinical teams may feel less comfortable deviating from reviewing 100% of informed consent documents or other trial materials for 'high-risk' studies," said Sarah Ray, senior research analyst at Cutting Edge Information. "By comparison, teams may choose to review a much smaller percentage of informed consent documents for trials considered low-risk."

Many life science companies map out RBM strategies well before trial initialization. Analysts found that surveyed pharmaceutical and device teams initiate RBM planning as early as a year before trials are underway. On average, surveyed teams begin constructing RBM plans 4.7 months ahead of trial launch.

Early planning equips teams with plenty of time to familiarize themselves with anticipated RBM monitoring activities. This is particularly important for teams with limited RBM experience. Teams that construct and finalize RBM plans ahead of schedule have greater opportunity to identify methodologies that may not work as well in practice -- and to propose new solutions -- before studies begin.

"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

Contact Information