Risk Based Monitoring

Risk-Based Monitoring

Achieve ICH E6 (R2) Compliance

Maximize the benefits of your Risk-Based Monitoring strategy by utilizing out-of-the-box functionality for SDV, Data Review and eSignature. Datatrak EDC and CTMS can generate KRIs, KPIs, and sponsor defined metrics for every step of clinical trial workflow, customizable to align with your processes and resource needs. This functionality allows the creation, implementation, and monitoring of both static and dynamic plans in real-time. These metrics are supported with dashboards that provide study health, recruitment, monitoring, data cleanliness status and reports.  

Features of RBM with Datatrak:
  • Percentage of overall data calculated automatically based on data quality monitoring, critical data and safety data.
  • User quality scores based on data points entered, data points SDV’d, and queries that caused data change. 
  • Remote data cleaning supports secure and centralized management of study documentation.
  • Our powerful ad-hoc reporting module let you configure your reports to the specifics of your RBM plan to identify early data trends and quality issues.
  • Edit checks activate upon data entry, reducing time, cost, and the amount of queries across the trial.
  • Operations insights provide real-time data aggregation of trial data across systems and across protocols.
  • Risk Based Management provides and end-to-end solution for Risk Based Monitoring, aligned with the most recent ICH E6 (R2) guidelines.
  • Portfolio oversight gives transparent reporting of progress across a portfolio of trials without vendor or CRO dependency.
  • Remote Monitoring allows surveillance of clinical trial progress with focus on risks, delays and inspection readiness.

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