Epidemiological studies evaluate the factors that lead to disease and other negative health outcomes. When you need to substantiate safety of your product for a new target market, to protect against claims, or for other strategies, clinical trials are neither the most cost effective nor scientifically valid studies for this purpose. Epidemiological research studies, such as case-control, retrospective or prospective cohort, cross-sectional, and ecological studies offer a cost effective approach that can confirm your product’s safety in relation to specific health outcomes.
Epidemiological studies may also be required as evidence for an IND or NDA application or to substantiate FTC claims. These studies provide valuable evidence regarding your product’s mechanisms of action, safety, potential clinical efficacy, and relationship to health outcomes in large communities. These studies can also help to identify potential avenues for further research you have not yet considered.
Our team can offer insight as to the suitability of epidemiological studies for your unique needs. We can also develop research protocols and conduct these studies for your company.