Lays Leonel

Background

About Lays Leonel

Epidemiology Research associate at IQVIA- Brazil RWE team. As an epidemiologist, I collaborate closely with global clients and various functional groups, offering leadership in real-world studies across a broad spectrum of designs and approaches. My work spans from early clinical development to the post-approval stage, encompassing the natural history of disease, external comparators, and the comparative safety and effectiveness of drugs, biologics, and devices. Under the guidance of senior staff, I design methodologically sound studies to meet project objectives and stakeholder requirements, including regulatory bodies and payers. I provide input on data elements and the design of electronic case report forms (eCRFs) when applicable, and I contribute to feasibility assessments and data landscaping. My role involves conducting and reviewing analyses, evaluating studies, and reporting findings. The complexity of my assignments varies, from feasibility input to the development of study protocols and clinical study reports, ensuring data quality and scientific rigor throughout all real-world studies. Additionally, I may contribute to new business development to maintain and strengthen our client base.