EVIDENCE GENERATION STRATEGIES

 

I develop evidence generation strategies that turn real-world data (RWD) into meaningful clinical, regulatory, and scientific insight. The focus is on generating evidence, and on ensuring that it is relevant, robust, and usable for decision-making across the product lifecycle.

 

This includes supporting study design, protocol development, and statistical analysis planning, ensuring alignment with both scientific standards and regulatory expectations. I work across non-interventional studies (NISs), hybrid designs, and large-scale post-marketing programs, including safety studies such as Post-Authorization Safety Studies (PASSs).

 

My experience spans global evidence generation, integrating data and insights from different regions and healthcare systems. This allows to build strategies that are both scientifically sound and operationally feasible at scale.

 

A key part of my work is also translating results into clear scientific outputs, whether for regulatory submissions, health authority responses, ethics committees, or publications. I focus on making sure that evidence is not only generated, but also communicated in a way that supports real decisions. This includes the development of regulatory documents, scientific publications, proposals and bid defense materials, and responses to health authority queries (e.g., PSURs and ethics committees).

 

Ultimately, the goal is to ensure that real-world evidence is fit-for-purpose: credible, consistent, and directly useful for regulatory, payer, and clinical stakeholders.