Targeted Data Quality Assessment

Targeted Data Quality Assessment focuses on a monthly analysis to pinpoint potential quality aspects that really matter within clinical and operational data. The sponsor can also determine its future Key Risk Indicators(KRIs) based on the output and identify discrepancies with extreme data scores that are observed.

This approach allows users to select critical domains within a study, such as safety data or primary /secondary endpoints, with a view to analyzing only these data that matter.  The CluePoints engine will analyze every variable pertaining to these critical elements and surface all significant anomalies across sites. The resulting visualization of results enables Clinical Operations staff or Data Managers to easily drill down into outliers and determine the corrective action required.

This is a more comprehensive analysis of important data but still easily interpretable by stakeholders within the study to find and remediate errant data and other anomalies.

Overall Data Quality Assessment

Overall Data Quality Assessment (DQA) identifies atypical centers, countries, regions and patients. All data is comprehensively analyzed every two to six months to get a quality stamp on data submitted. This ensures that data submitted to Regulatory Authorities is of the appropriate quality and affords sponsors with the ultimate risk mitigation tool to enable Risk-Based Monitoring (RBM)

Whilst this rigorous interrogation of all the clinical data is more sophisticated than both the KRIs or Targeted Data Quality Assessment solutions, it is still an unsupervised and automated analysis of all clinical data that allows users a complete assessment of the quality and integrity of clinical data.

When put in the hands of Data Managers or Biostatisticians, the Overall Data Quality Assessment is the ultimate risk mitigation tool that regulatory authorities recommend to detect anything from unintentional errors (miscalibrated equipment), propagation of patient data, site training issues, misunderstanding of protocols and, ultimately, fraud.