SOURCE: Cutting Edge Information

Cutting Edge Information

November 03, 2014 05:00 ET

Risk-Based Monitoring: Pharma Doesn't Need to Reinvent the Wheel

Study Finds That 41% of Biopharma and Medical Device Organizations Have Dedicated RBM Teams

RESEARCH TRIANGLE PARK, NC--(Marketwired - November 03, 2014) - Encouraged by favorable FDA and EMA publications, a significantly increasing percentage of life sciences companies have begun implementing risk-based monitoring (RBM) strategies, according to a new Cutting Edge Information study. 

While contract research organizations (CROs) and academic institutions are each no stranger to RBM, implementing the methodology has historically represented a strategic overhaul for large and mid-sized pharmaceutical teams. Although pharmaceutical and biotechnology organizations have the necessary in-house expertise -- from data managers to biostatisticians -- rarely do these clinical roles sit within a dedicated RBM group.

Using guidance proposed by industry group TransCelerate as a springboard, pharmaceutical and device teams have worked to repurpose existing clinical groups into dedicated teams, well-positioned to support centralized, triggered, remote and reduced risk-based monitoring tactics. Yet, a year later, many surveyed pharmaceutical teams have yet to implement dedicated RBM groups. Cutting Edge Information's recent study found that compared with the 73% of surveyed CROs with dedicated risk assessment teams, similar structures are present at only 41% of surveyed life sciences organizations. But that percentage is steadily growing.

Companies that presently lack dedicated groups may opt instead to expand the responsibilities associated with existing clinical roles. For example, teams lacking a formal statistician may incorporate similar duties into data managers' job descriptions. While the former approach more aptly represents guidance proposed by TransCelerate, Cutting Edge Information's research found that avoiding a structural overhaul, by redefining individual clinical roles may provide similar RBM support, at a lower operational cost.

Cutting Edge Information's recently-released 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 study 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 overcomplicating RBM techniques
  • Balance existing budget and staffing resources
  • Map out clinical strategy well before trial initialization

For more information about clinical trial management research, contact Elio Evangelista at 919-403-6583.

Contact Information

    Elio Evangelista