Satisfy Regulatory Requirements With Help From Our Perinatal Pharmacoepidemiology Research Team
The safety of medical products when used in pregnancy is often not well characterized at the time of marketing authorization unless they are specifically developed to treat conditions related to pregnancy. If you have a new drug, biologic, vaccine, or medical device entering the market, or have approval for a new indication for an existing product, you will likely be required by regulatory agencies to assess the safety of your product if pregnant persons might use it. Typical requests from regulatory agencies include studies with prospective data collection and studies that make secondary use of existing data sources—using real-world data to generate real-world evidence (RWE).
We have extensive experience in perinatal pharmacoepidemiology and have reviewed study approaches typically required by regulatory authorities, so you can confidently partner with us to conduct the regulatory RWE research needed to meet these requests. Our studies use real-world data in their native format or transformed into a common data model. Our team can also assist you with studies to describe the natural course of diseases as well as other research, including literature reviews and RWE studies with primary data collection to help you ensure you have reliable data to inform your internal decision-making process.
In addition to helping our clients address their regulatory requirements, we also conduct independent academic research and have contributed to the ENCePP Guide on Methodological Standards in Pharmacoepidemiology; we co-authored its annex on methods for research in pregnancy and breastfeeding. We have experience coordinating multidatabase studies and are members of the VAC4EU and the SIGMA consortia. We have also taken the role of research site analyzing data and providing epidemiological and statistical support to the study coordinating team.