SOURCE: Cutting Edge Information

Cutting Edge Information

May 11, 2016 00:00 ET

Eighty Percent of Surveyed Top 10 and Top 50 Teams Use Risk-Based Monitoring

Even Companies That Don't Formally Conduct RBM Activities Benefit From Some of Its Practices

RESEARCH TRIANGLE PARK, NC --(Marketwired - May 11, 2016) - Risk-based monitoring (RBM) presents an alternative to in-person monitoring for life science companies' clinical trials. According to data from primary intelligence firm Cutting Edge Information, RBM tactics are used by 80 percent of surveyed large and mid-sized companies. Only 38 percent of small and biotech companies, however, leverage this remote monitoring technique.

In many cases, constrained staffing and budgetary resources have persuaded companies to consider non-traditional forms of site management -- namely RBM. Surveyed teams at Top 10 and Top 50 organizations rated RBM less challenging than small and biotech teams and were, therefore, more likely to use it. According to interviewed executives, many companies are open to RBM but may be uncertain how to best utilize it. Additionally, cutting back on existing, in-person monitoring practices can be difficult.

"Even companies that don't formally conduct RBM activities benefit from some of its practices," said Sarah Ray, senior research analyst at Cutting Edge Information. "For example, teams are more likely to frequent sites that generate higher numbers of queries. Companies often review data and adjust planned monthly site visits based on what that data reveals."

According to Clinical Outsourcing: Leverage Sponsor-CRO Relationships to Accelerate Trial Timelines, cutting back on existing, in-person monitoring practices can be difficult. An interviewed executive at one medical device company noted that it may be hard for clinical monitors -- who have historically conducted 100 percent source data verification -- to shift to analyzing only key fields, such as patient safety. This executive estimates that before RBM can have a substantial impact on companies' site monitoring processes, trial monitors will first need to become more comfortable with spending less time off-site and with analyzing only selected, critical data.

Clinical Outsourcing: Leverage Sponsor-CRO Relationships to Accelerate Trial Timelines, available at http://www.cuttingedgeinfo.com/research/clinical-development/outsourcing-selection-strategy/, guides clinical executives through clinical outsourcing partnerships and planning. Report highlights include:

  • Metrics detailing clinical trial activities from pharmaceutical, device, CRO and site perspectives.
  • Data on surveyed teams' vendor selection process and preferred collaboration type (master services agreement versus functional service provider).
  • Best practice recommendations and projected costs associated with selected patient recruitment activities.
  • Profiles of 17 pharmaceutical, biotech, device and CRO-managed clinical trials, including overall trial costs, number of enrolled patients and sites and clinical team size.

For more information about clinical outsourcing practices, please visit http://www.cuttingedgeinfo.com/research/clinical-development/outsourcing-selection-strategy/.

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