Analytics Insights Allow Mitigation of Fraudulent Data in Global Trial
In a Phase II dermatology trial, a global biopharmaceutical company faced the challenge of monitoring data quality across 110 sites in 10 countries with 350 patients—a scenario where traditional monitoring methods struggle to detect subtle quality risks.
This multi-site, multi-country design created significant monitoring challenges, with rapid recruitment occurring simultaneously and relatively small patient numbers per site making it difficult to identify patterns that might indicate data quality concerns or fraudulent data.
The solution? Signant's PureSignal Analytics provided specialized, end-to-end monitoring of both clinician-reported and patient-reported outcomes across all study sites, deploying proprietary analytics to detect potential issues, outliers, and anomalies in real-time.
The results? Immediate identification, investigation, and mitigation of COA data concerns during study conduct, with ongoing clinician-driven reviews enabling evidence-based intervention recommendations to ensure high-quality endpoint data.
The approach also helped validate the use of advanced analytics in complex global trials, proving that sophisticated monitoring solutions can successfully manage data quality across large, dispersed study networks while maintaining inter-rater consistency.
See how Signant's PureSignal Analytics solution enabled proactive identification of data quality concerns, including fraudulent patterns, provided real-time monitoring across 10+ COAs in 10 languages, and delivered swift interventions to protect trial integrity in this challenging multi-site environment.
