Xcellerate Risk Review

Xcellerate® Risk Review enables comprehensive risk assessment at the site, country and study levels. With full support for operational workflows and adaptive and triggered monitoring interventions, study teams can implement timely risk mitigation at the correct level to ensure that emerging risks do not become issues for a study.

Xcellerate Risk Review’s periodic automatic assessment uses configured risk indicators to calculate combined risk score and generate recommendations to prioritize, increase or decrease monitoring intervention for each site. It provides a holistic review that allows study teams to implement timely mitigations at the correct level, providing significant quality and efficiency benefits:

  • 46% reduction in critical findings from monitoring oversight visits
  • 28% reduction in important protocol deviations
  • 34% reduction in on-site monitoring time

Throughout the execution of a clinical trial, issues are generated from a variety of disparate and unconnected systems. This lack of uniformity leads to compliance issues, process inefficiencies and lack of transparency into the progress of the study.

Xcellerate Risk Review provides a single custom-built user interface independent of underlying trial management systems, allowing study teams to:

  • Monitor risks and performance of clinical sites through ongoing review of key risk indicators and supporting data
  • Quickly identify sites with elevated risks and review their performance
  • Adjust site monitoring strategies based on observed risks and assign actions within the system
  • Employ standard and study-specific risk indicators
  • Document compliance with risk-based monitoring strategies

Benefits of Xcellerate Risk Review:  

  • Agnostic: integrates into existing trial management source systems
  • Compliant: supports adherence to ICH GCP and other guidelines through audit trails and history tracking
  • Easy-to-use: provides user-centric web and mobile user interfaces 
  • Effective: offers fast access to critical information with visualizations for metrics reporting and trending
  • Efficient: accelerates and automates issue resolution through an advanced workflow engine 
  • Future-proof: scales to current and future data volumes via state-of-the-art architecture