DISCOVER MY CAPABILITIES
I help organizations use real-world data (RWD) to support decisions across R&D, safety, medical, and commercial teams.
My work focuses on practical approaches, aligned with regulatory requirements, internal priorities, and operation efficiency.
I take on projects across the full RWE lifecycle: assessing whether data can answer key questions, designing non-interventional studies (NISs), and producing evidence that guides business and scientific decisions.
The emphasis is on using data to inform decisions aligned with regulatory requirements and internal priorities.
Areas of expertise
Evidence & Data Strategy
Designing RWE programs and NISs that meet organizational needs, with clear links between study objectives, feasibility, and regulatory requirements.
Pharmacoepidemiology & Drug Safety
Supporting observational research and post-authorization safety studies (PASSs), using methods aligned with product safety, lifecycle evidence, and compliance standards.
RWD Feasibility & Proxy Outcomes
Assessing data quality and availability, developing proxy outcomes when needed, and translating feasibility findings into study designs that teams can apply effectively.
Data Governance & Regulatory Alignment
Advising on data governance, decision pathways, and alignment with GVP/GCP requirements, including EMA and FDA interactions for post-marketing commitments.
Scientific Communication & Thought Leadership
Explaining complex methods and operational issues to senior stakeholders in clear terms. Author of over 60 articles on RWE methods, data strategy, regulations, and feasibility.