Our medical and PV experts evaluate benefits, risks and use of drugs used in real world conditions.
From performing systematic literature search and meta-analysis in assessing safety of pharmaceutical products to inform regulatory decision-making (as per CIOMS Working Group X Report) 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 and drug safety.
Our aim is to help you enhance the safety and benefits of medicines used in real world conditions.
- Methodological research from a safety perspective in pharmacoepidemiology and medication safety e.g., identify solutions for natural history studies when challenged by strict data protection/privacy regulations in Europe and US
- Epidemiological 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
- Epidemiological research to better characterize potential risk associated with the use of the product in pregnancy and breastfeeding. Provide advice on whether conducting a PASS may investigate specific risks to the embryo, fetus or child is a better option to implementing pure epidemiological 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.