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Statistical Monitoring for Safer, Smarter Clinical Trials

Explore how advanced statistical tools improve clinical trial safety by detecting data anomalies, reducing risk, and enhancing trial monitoring efficiency.

Healthark
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Statistical Monitoring for Safer, Smarter Clinical Trials

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  1. CASE STUDY Clinical Trial Safety Monitoring Using Statistical Analysis

  2. THE CHALLENGE Global CRO Advancing Safety Monitoring with RWD Integration in Clinical Trials Our client is a globally renowned CRO specializing in real world data (RWD) solutions & clinical research. Headquartered in the US, the organization supports pharmaceutical clients in Europe & the US by leveraging cutting-edge technologies to analyze datasets. The client was conducting a large-scale clinical trial to assess the safety and efficacy of an investigational therapy. The study aimed to capture detailed adverse event (AE) data and clinical test results to evaluate patient safety. This information was critical for ongoing safety oversight by the Data Safety Monitoring Board (DSMB) & to support key regulatory submissions.

  3. HEALTHARK’S ROLE Statistical Safety Assessment Framework Healthark developed a structured analytics approach to streamline AE evaluation and ensure clear safety reporting for DSMB meetings. Requirements Gathering Cohort Mapping QA/QC Statistical Analysis

  4. THE IMPACT High-Impact Trial Safety Insights Generated 12+ safety profiles, 15 frequency reports, & 10 data-backed DSMB recommendations, enabling early detection of safety signals & accelerating trial phase decisions.

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