Davide Gaudesi

Background

About Davide Gaudesi

Clinical Data Expert & Innovator with 15+ years of experience driving data quality, compliance, and efficiency across more than 150 global clinical studies. I specialize in turning complex data challenges into scalable solutions: from EDC and CRF design (>100 CRFs) to protocol review and development (>80 protocols), and from data validation edit checks implemented) to automation through R and SAS. My work consistently reduces timelines and improves data integrity, ensuring studies meet both regulatory standards (ICH GCP, CDISC, 21 CFR Part 11, GDPR) and scientific goals. Beyond operations, I contribute to the scientific community as a writer and thought leader: more than 300 posts on Clinical Data Management, 10+ articles, and 13 peer-reviewed papers, alongside successful grant applications and SOP frameworks (>30 SOPs). What drives me is a vision: elevating Clinical Data Management from a support function to a strategic partner in clinical research. By combining regulatory insight, technology adoption, and cross-functional collaboration, I aim to make clinical data not only compliant, but also actionable, interoperable, and future-proof. Always open to discussing how digital health, automation, and data science are reshaping the landscape of clinical research.