Bridging the Regulatory Gap: Real-World Data Quality in Cancer Research

Real-world data holds immense potential to strengthen oncology research, regulatory decisions, and clinical care, but raw electronic health record (EHR) data must undergo continuous standardization and rigorous validation before it can generate reliable evidence. In this interview, Dr. Jessica Paulus explores how Ontada operationalized FDA and EMA data quality frameworks across its ON.Genuity platform, moving data quality from subjective review to continuous, measurable governance across 4 million patient records. Read the full accompanying article on Oncology Data Advisor: https://bit.ly/4AQPjW2 What You’ll Learn in This Episode: 🔹 Shift to Enterprise Data Quality: How FDA Q-CARD and EMA Data Quality Frameworks (DQF) transition quality evaluation from one-off study checks to platform-wide, reproducible measurement. 🔹 Operationalizing Frameworks in ON.Genuity: Standardizing 250+ oncology variables using FHIR and mCODE principles across 4 million patients and 700+ community oncology clinics. 🔹 External Survival Validation: Assessing data accuracy by comparing EHR-derived overall survival against National Death Index (NDI) mortality data in metastatic pancreatic cancer. 🔹 Quality Monitoring in Action: Interpreting standard edit checks, discrepancy resolution, and why identifying logical conflicts proves continuous monitoring is working. 🔹 Defining Fitness for Purpose: Evaluating how level of completeness and quality must align with specific regulatory, clinical, or payer decision-making needs. Chapter Timestamps: About the Speaker: Jessica Paulus, ScD, is the Vice President of Real-World Research at Ontada, where she leads real-world evidence research initiatives and the operationalization of data quality frameworks across oncology datasets. Stay Connected: Subscribe for more expert discussions on oncology practice, research, and technology.