Pharmacoepidemiology and Risk Management Solutions

Prospective observational research, Registries

We support clients in the design and implementation of prospective observational research approaches, including cohort studies, patient registries, and surveys of patients or HCPs, as part of risk management programs or plans.

This includes als steps of an observational study from protocol development and writing of plans or reports, to coordinating or leading the study. The clinical research experience of ERGOMED also allows us to offer support in managing study operations, and our regulatory affairs colleagues within Primevigilance can provide regulatory support, such as responses to regulatory authority questions if studies are conditions of marketing authorization.

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