SOURCE: Cutting Edge Information

Cutting Edge Information

November 04, 2015 12:04 ET

41 Percent of Surveyed Life Sciences Companies Report Using Dedicated Groups in Risk-Based Monitoring Operations

In-House Capabilities and Expertise Facilitate Remote Clinical Risk Assessments, but Many Teams Overcomplicate Their Approach

RESEARCH TRIANGLE PARK, NC--(Marketwired - November 04, 2015) - Risk-based monitoring (RBM) has emerged as a solution for trial sponsors to stay abreast of clinical trial progress across all enrolled sites, without necessarily requiring teams to visit each site on a monthly or quarterly bases. The idea behind RBM is to develop a practice that helps life sciences companies maintain their trial protocols without generating more work for sponsor or contract research organization (CRO) teams. According to primary intelligence provider Cutting Edge Information, 41 percent of surveyed life sciences teams and 73 percent of CRO teams report involving dedicated groups in their RBM operations.

A surveyed executive at one CRO has developed and operated under risk-based monitoring approaches for more than 15 years. She noted that pharmaceutical companies may become intimidated by RBM as a new practice, rather than examining the core of its functionality. Part of the challenge lies not in the RBM strategy itself, but rather in companies' collective tendency to overcomplicate their approach.

According to the executive, instating a sound risk-based strategy is not about building the fanciest platform or developing the most complicated risk-threshold scheme. Instead, building a robust RBM strategy boils down to one key practice: adapting in-house capabilities and expertise to facilitate remote clinical risk assessments.

"Many surveyed organizations -- particularly large and mid-sized pharmaceutical organizations -- reported establishing dedicated risk-assessment teams," said Sarah Ray, senior research analyst at Cutting Edge Information. "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."

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 http://cuttingedgeinfo.com/.

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