Xcellerate Risk Review

Value it Brings to the Outcome of a Trial

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:

Overview:

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