A: GIVEN THE POTENTIAL TO POSITIVELY IMPACT the quality and cost of clinical monitoring, the implementation of risk-based monitoring (RBM) with analytics and cloud-based approaches needs to be accelerated. But implementation is not simply retrofitting existing approaches, but a fundamental change to the process via QbD principles (e.g., development of monitoring plans that incorporate real-time data and analytics to trigger monitoring visits). What is required is industry change management, including extensive collaboration among regulators, sponsors, CROs, and clinical trials sites. If you are to disrupt the clinical trial process, you need to ensure there are no gaps in training, processes, or technologies that could negatively impact data quality or patient safety.
JOHN HUBBARD, PH.D.
John is a member of the board of Agile Therapeutics and CEO of Bioclinica. He has over three decades of experience, including executive-level positions with Pfizer, ICON, PAREXEL, and Hoechst Marion Roussel Pharmaceuticals.