When you need a reliable solution to ensure data integrity, look to YPrime’s data monitoring services.
Questionnaire and instrument compliance are mission critical when eCOA data support key endpoints. Data monitoring is a specialized service that provides an early warning system for pivotal studies to alert study teams of potential compliance risks that may escalate into liabilities. YPrime’s data science team applies targeted algorithms to enable rapid, automated eCOA data review that flags trends of interest or anomalies. YPrime can also implement a combination of automation and clinical expertise for targeted, manual review of select data points.
Within eCOA data sets, data monitoring can help identify questionnaire and instrument compliance patterns that are below or near threshold levels, allowing for additional analysis to evaluate the scope and severity of the issue. Clinical expertise is available to assess the issue in the context of protocol requirements. Our data science team can help identify missing data, inconsistent data, data outliers, unexpected lack of variability and protocol deviations. We also examine data trends such as the range, consistency, and variability of data within and across sites.
Data monitoring not only allows study teams to address current compliance or safety risks in real-time but also provides the ability to reduce future risks, and help studies run more efficiently. Once enough data are gathered, predictive risk-based modeling can anticipate non-compliance situations and trigger preemptive actions. Insights gained from data monitoring in real-world usage can lead to better protocol designs in the future.