Xcellerate Risk & Issue Management

Value it Brings to the Outcome of a Trial

Xcellerate Risk & Issue Management provides a holistic repository for risks, actions, protocol deviations, issues and decisions, with escalation capabilities, meeting minutes and reporting. This agnostic system allows Clinical Research Associates (CRAs), central monitors, project managers and the rest of the study team to manage all risks, actions, protocol deviations, issues and decisions (RAPIDs) from a single custom-built user interface independent of the underlying trial management systems.

Using Xcellerate Risk & Issue Management can increase operational efficiency and compliance while reducing risk and providing significant quality benefits, including a 60% increase in issues resolved within 20 days.

Overview:

When issues are generated throughout the execution of a clinical trial using a variety of disparate and unconnected systems, there is an inherent risk of compliance issues, process inefficiencies and lack of transparency into the progress of the study.

Xcellerate Risk & Issue Management creates a single system of record for the study team to create, view and manage issues, including those generated from quality by design, central monitoring and on-site/remote monitoring activities in near real-time. Fully 21 CFR Part 11 compliant, Xcellerate Risk & Issue Management enables custom and automated escalation, cascading actions across sites, conversion between issues and protocol deviations.

Benefits of the Xcellerate Risk & Issue Management:

• 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