A Plea to RBM Tech Vendors


A risk-based approach to quality trial oversight, adopted by the FDA and EMA, has resulted in an array of new technology solutions being released.

With the release of the FDA and EMA Guidance on adopting a Risk-based approach to quality trial oversight, a plethora of new tech solutions have been released.   MANA RBM evaluates all new technology used for Risk Based Monitoring (RBM) and Remote Trial Management. While the tools all provide beautiful graphs on Key Risk Indicators (and some provide good tools for Risk Assessment and Issue Management), most do not provide any ability to develop ad hoc reports for trial oversight.     This is a major limitation for two reasons:

  • Each trial has protocol specific, high-risk data and processes that require oversight as part of the trial process. This functionality (a core Guidance premise) is missing from most tools available.  

  • When a risk threshold is reached, additional review of trial conduct for that site must be performed. For instance, if the rate of deviations is higher than expected at a site, it triggers reviewing the types of deviations and other aspects of trial conduct for that site. This additional review of data can and should be done remotely. When a trigger is reached, the automatic response is to fully understand that site’s (and the individual members of the site team) performance-not just send a monitor to the site as a knee jerk response. While a site visit may be required, a significant amount of work can and should be done before deciding whether a site visit is needed.

To truly accomplish responsible, comprehensive, proactive oversight of a trial remotely, we must be able to:

  • Access all data, document sources, and metrics remotely

  • Develop ad hoc reports that pull data from any/all data sources

  • Design reports specifically for the trial requirements, including visualizations for Source Data Review, and not just use a tool that provides beautiful visualizations but lacks the ability to delve deeper into the data

We are thrilled the technology vendors are providing some wonderful, new tools. We hope they will listen to our industry’s needs and provide tools and implementation support to help sponsors adopt the FDA and EMA Guidance and the new ICH changes in Good Clinical Practice that become final this year (2016).   Penelope Manasco, MD is CEO of MANA RBM and can be reached at Pmanasco@manarbm.com

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