Our medical and PV experts evaluate benefits, risks and use of drugs employed in real world conditions.
From performing systematic literature search and meta-analysis to reviewing study protocols and ensuring data quality and scientific rigor across all facets of epidemiology projects, our team of experts can assist you in pharmacoepidemiology (PE) and drug safety.
Our aim is to help you improve the safety and bolster the benefits of medicines used in real world conditions. Real World Evidence (RWE) derived from well-designed studies, with application of rigorous epidemiologic methods, can offer robust evidence on safety and effectiveness.
Focus Areas
- Methodological research from a safety perspective in PE and medication safety e.g., identify solutions for natural history studies when challenged by strict data protection/privacy regulations in Europe and US taking into consideration the ENCePP Guide
- Epidemiologic research to identify the incidence, cause and risk factors for adverse drug reactions and medication errors e.g., provide advice on the design of cohort and/or case-control studies as part of an additional PV Plan for safety specification as requested by EMA, FDA and PMDA
- Epidemiologic research to better characterize potential risk associated with the use of the product in pregnancy and breastfeeding. Provide advice on whether conducting a PASS to investigate specific risks to the embryo, fetus or child is a better option to implementing pure epidemiologic designs, such as pregnancy (exposure) registries
- Epidemiology of the medical condition(s) or risk factors that reflect the authorized indication(s) in regions other than the EU have been analyzed and information is transposed to RMPs requested by other ICH regions
- Quantitative and qualitative research into the causes of adverse drug reactions and medication errors.
