Pentara is redefining “data integrity” by utilizing sophisticated anomaly detection to identify site-level risks and paradoxical patient patterns before they impact your trial’s primary endpoints. The integrity of clinical trials is currently under threat from increasingly sophisticated fraudulent practices, which flourished in the post-COVID environment. Research indicates that in Alzheimer’s studies not requiring PET scans, approximately 10% of sites may have anomalies in up to 20-30% of enrolled subjects. Deceptive practices range from "professional patients" to simulated clinical outcome data, and can jeopardize data integrity and introduce a significant negative bias. Left unchecked, these practices can reduce the observed effect size and increase variability, potentially canceling out a true treatment effect and cause a viable, life-changing therapeutic to fail its clinical trial.
Pentara offers a specialized "Data Anomaly Detection and Monitoring" toolbox designed to identify and mitigate these risks where traditional regulatory audits and standard data management fail. Our team utilizes advanced, blinded statistical algorithms and medical audit methods to detect issues that remain invisible to conventional oversight. By incorporating deep medical expertise and targeted data analysis, we help sponsors protect their investment, safeguard vulnerable populations, and ensure that the true efficacy of a drug is clearly observed. Partnering with Pentara means moving beyond basic compliance to an effective data-driven defense of your trial’s success. To read how our team is using ML-based detection to identify site-level fraud in Alzheimer’s trials see our paper published in Alzheimer’s & Dementia Journal.
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