Epidemiological and observational studies
Observational studies are increasingly used in drug development. They allow us to study the actual behavior and reactions in real populations. The purpose of observational studies is often to gather information on aspects that cannot be captured by traditional randomised experimental studies. One can for example be interested in compliance, health economics or adverse events in the population in which the drug will be launched. While a randomised study is ideal for the study of causality, such conclusions are difficult to draw in observational studies.
To meet this challenge, epidemiological methodology should be used for statistical analyses. At SDS, we have a solid background in epidemiological statistics, both in applied projects and in method development.