Advanced Analytics and Central Review Enhance Assessment Quality

In a large-scale Phase III neurology trial, a global pharmaceutical company faced the monumental challenge of maintaining assessment quality across 200+ sites and 1,500+ patients in 14 countries with multiple complex clinician-reported outcome measures, including the primary endpoint.

This massive global trial created significant endpoint data quality monitoring challenges, where maintaining correct administration procedures and accurate scoring throughout the study was essential to achieve endpoint reliability and optimize signal detection potential across diverse international locations.

The solution? Signant implemented PureSignal Analytics alongside independent central review of audio recorded rating interviews, providing comprehensive, real-time endpoint data quality oversight through proprietary analytics that continuously monitored administration procedures and scoring patterns.

The results? Rapid detection of problematic assessment patterns and timely delivery of corrective interventions, with independent expert review of assessment recordings enabling immediate feedback to site raters when administration or scoring errors were identified.

The approach also helped validate the use of integrated analytics and central review in large-scale global trials, proving that comprehensive quality oversight can successfully manage complex ClinRO assessments across hundreds of sites while maintaining consistent data quality standards.

See how Signant's combined PureSignal Analytics and central review solution enabled real-time quality monitoring across 6 COAs in 12 languages, provided immediate corrective feedback to site raters, and delivered the highest quality clinical outcome assessment data in this challenging global neurology trial environment.