Our expertise

The experts at the PHARMO Institute, part of Lumanity, perform tailor-made observational research using real world data to help our clients to effectively bridge the gap between clinical trial data and real world evidence. Our staff consists of academically trained specialists in epidemiology, pharmacotherapeutics, medicine, and informatics.

The PHARMO Institute acts as a coordinating center in multi-country studies, developing common protocols and programming that run on both our in-house data and our partner data sources. Our global studies provide critical evidence in the context of emerging standards for study design, database and analysis operations, and quality assurance. Specifically, we help our clients with:

• Post-authorization safety and efficacy (PASS, PAES) and drug utilization review (DUR)
• Incidence/prevalence, treatment patterns, and patient pathways
• Comparative effectiveness, including synthetic control arms
• Healthcare resource use and cost of illness research
• Validation of surrogacy outcomes
• AI patient finding, classification, and disease progression prediction

We regularly collaborate across Lumanity to leverage deep scientific, clinical, medical, regulatory, and commercial expertise in support of complex client decision-making and execution throughout the asset value creation and demonstration journey. These industry-leading experts, jointly with our epidemiologists and statisticians, ensure that our clients’ investments in real world evidence are optimized to meet the expectations of the U.S. Food and Drug Administration, European Medicines Agency, and payers/health technology assessment bodies. We work together to carefully define methods of cohort selection, outcomes ascertainment, and demonstration of relative intervention effects, improving the likelihood of a study to achieve our clients’ underlying scientific aims.  

The PHARMO Institute adheres to high standards throughout the research process based on robust methodologies, transparency, and scientific independence. Our internal standardized procedures and quality guidelines are in accordance with the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology, the ENCePP Code of Conduct, and good pharmacovigilance practice (GVP) to guarantee high quality services.