Delivered High-Performance Statistical Computing To Transform Complex Rwe Data Into Actionable Insights
Overview
A global leader in medical devices, with over 5.4 million treatments delivered and 150,000+ patients treated, required expert support in harnessing real-world evidence (RWE) and real-world data (RWD) to assess the effectiveness of treatments for Major Depressive Disorder (MDD) and associated anxiety symptoms. The client sought a reliable partner not only to streamline and analyze vast, complex datasets but also to enable high-impact publication efforts.
ACL Digital Life Sciences was selected for its in-depth expertise in statistical computing, data analysis, and regulatory-compliant documentation, thereby forming a strategic extension of the client’s internal team.
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Challenges
The project’s scope was ambitious and technically demanding. These complexities necessitated a solution that combined scalable infrastructure, robust statistical expertise, and dynamic team collaboration
Highly intricate and layered database structures designed to track depressive episode severity
Data from approximately 140,000 active patients, each with a minimum of 36 treatment sessions, stored across ~130 relational tables
Widespread data inconsistencies and significant missing information
Need to integrate and relate multiple tables to extract accurate, relevant insights
Continual evolution of client needs and frequent ad hoc reporting requests
Solution
ACL Digital Life Sciences empowered the client to transform raw, disparate RWE data into clinically valuable insights that informed both strategic decisions and scientific publications. Leveraging robust statistical infrastructure, deep domain expertise, and an agile, solutions-driven approach, the engagement enhanced the client’s ability to analyze complex datasets and deliver publication-ready outputs. To achieve this, ACL Digital Life Sciences implemented a comprehensive, multi-disciplinary strategy:
- Discovery Phase: Conducted an in-depth assessment of all data sources, dependencies, and analytical use cases.
- Secure Computing Environment: Established a high-performance statistical computing setup with VPN, sFTP portal, and SAS software to ensure secure and efficient data processing.
- Statistical Analysis Plan (SAP): Drafted a detailed SAP outlining objectives, study design, population analysis, treatment effectiveness, and course durability aligned with client specifications.
- Data Integration and Cleanup: Linked primary and foreign key variables across tables and identified and eliminated discrepancies to ensure only legitimate data were analyzed.
- Advanced Statistical Modeling: Applied correlation and regression models to study treatment efficacy about gap days between sessions.
Outcomes
ACL Digital’s high-caliber team of biostatisticians, statistical programmers, and medical writers delivered impactful results:
- Generated Summary Tables: Using MEAN, FREQ, ANOVA, and CORR procedures, ACL Digital produced comprehensive statistical summaries including mean, median, standard deviation, and p-values
- Effectiveness Metrics: Calculated responder and remission rates using PHQ-9 scores to measure therapeutic outcomes
- Visualized Insights: Developed bar charts, scatter plots, and correlation graphs to illustrate relationship
- Insightful Data Interpretation: Biostatisticians leveraged these visual and statistical outputs to uncover actionable insights
- Publication Support: Medical writers transformed technical outputs into a publication-ready manuscript, now under peer review
