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