Sezal Panchal

Led real-world data (RWD) management and advanced clinical data analytics for 12 national registries (650,000+ patients, 200+ sites) under ICH-GCP and DSGVO compliance. Designed validation frameworks ensuring 99%+ data quality, performed survival analysis, multivariate modeling, and propensity score methods. Enabled evidence generation, site performance monitoring, and cross-functional collaboration to support clinical research, benchmarking, and regulatory-grade insights.

Generated real-world evidence (RWE) to support market access, reimbursement, and regulatory submissions across European markets. Conducted systematic literature reviews and observational research for robust evidence synthesis. Developed HTA documentation, study protocols, and analytic plans aligned with EMA and payer requirements. Collaborated cross-functionally to drive evidence-based decision-making and scientific communication.

Managed end-to-end pharmacovigilance operations at a global CRO, including ICSR processing, MedDRA coding, case assessment, and expedited reporting. Ensured compliance with ICH-GCP, GVP, and global regulatory requirements. Maintained safety databases (Argus), TMF/PSMF readiness, and signal detection activities. Supported regulatory submissions, audits, and cross-functional safety monitoring across clinical trials and post-marketing programs.

Completed a Master of Science in International Health at Charité – Universitätsmedizin Berlin, focusing on epidemiology, global health systems, and evidence-based research. Conducted a thesis on COVID-19 mathematical modeling through systematic review. Gained strong expertise in biostatistics, epidemiology, public health research, and data-driven healthcare analysis, supporting clinical research, policy evaluation, and international health initiatives.