Client Background
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 and clinical research. Headquartered in the US, the organization supports pharmaceutical clients in Europe and 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) and to support key regulatory submissions.
Challenge
Limited Clarity on Safety Signals
The client faced difficulty in drawing consistent, statistically valid conclusions from AE data due to missing records, test inconsistencies, and complex cohort structures. These issues delayed DSMB reviews, created risk exposure, and limited the ability to make informed go/no-go decisions during trial phases.
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 Collaborated with cross-functional teams to identify safety-critical data and align with clinical endpoints.
- Cohort Mapping Mapped trial subjects to protocol-defined cohorts to ensure analytical consistency.
- QA/QC Performed comprehensive data cleaning, imputation of missing values, and outlier detection.
- Statistical Analysis Conducted both descriptive and inferential analysis to highlight AE trends and test result variations.
Empowering Tomorrow's Healthcare
This case study showcases how Healthark’s statistical expertise optimized clinical trial monitoring for a global sponsor. Through structured data validation, robust analysis, and efficient safety profiling, we enabled faster, evidence-based decision-making, reduced risk exposure, and supported clinical trial continuity.
Want to learn more about Healthark’s expertise in RWE & clinical data analytics? Explore our website or contact us today!
