SOURCE: Cutting Edge Information

Cutting Edge Information

October 25, 2016 08:17 ET

86% of All Health Care and Device Companies Report Clinical Operations Groups Involvement in Risk-Based Monitoring Activities

RESEARCH TRIANGLE PARK, NC--(Marketwired - October 25, 2016) - Although drug and device companies do not view dedicated risk-based monitoring (RBM) teams as a necessity, their clinical operations teams often have the functionality needed for conducting RBM activities, according to industry research published by Cutting Edge Information.

Provided that companies have strong lines of communication throughout trial duration, clinical operations teams can initiate risk-based monitoring programs without realigning their existing structures.

The study, Risk-Based Monitoring: Inject Remote Risk Assessment to Optimize Clinical Trial Outcomes, revealed that 89% of clinical operations groups within pharmaceutical and medical device companies are involved in risk-based monitoring activities. Half of the surveyed scientific and medical affairs units in these businesses reported contributing to these risk-based monitoring activities.

However, outsourced RBM tends to be a popular choice, according to the study's data. In fact, 73% of surveyed CROs claimed that they have dedicated risk assessment teams, clinical trial investigators, and clinical operations units that are involved in risk-based monitoring activities. These centralized teams leverage the combined expertise of data managers, statisticians, drug safety and clinical research associates and consolidate them under a single oversight role. A smaller percentage of other groups from CROs admitted involvement in risk-based monitoring activities:

  • Drug safety teams (36%)
  • Regulatory affairs (36%)
  • Scientific/medical affairs (18%)

"The idea behind risk-based monitoring is to develop a practice that helps companies maintain their clinical trial protocols without creating more work for sponsor or CRO teams," said Sarah Ray, Senior Research Analyst at Cutting Edge Information. "Part of the challenge lies not in the RBM strategy itself, but rather in companies' collective tendency to overcomplicate their approaches."

Many organizations are moving forward with RBM strategies in hopes of lowering overall spending. Companies must be prepared to update their technology to undertake RBM initiatives. Risk-Based Monitoring: Inject Remote Risk Assessment to Optimize Clinical Trial Outcomes, available at, provides information on budgets and staffing for risk assessment teams and RBM activities.

The study includes:

  • RBM best practices
  • Industrywide RBM trends in a changing clinical monitoring landscape
  • Key steps to help implement RBM to help executives reduce overall clinical costs
  • RBM framework and tactics to allow clinical teams to remotely track sites' progress during trials
  • Profiles of life sciences companies that participate in risk-based monitoring

For more information on Cutting Edge Information's clinical operations or risk-based monitoring research visit

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