A Feasibility Analysis is a comprehensive assessment of a clinical trial, which includes risk stratification and contingency planning. Our Feasibility Experts review the study protocol, design, epidemiology data, investigate site and patients’ motivations, regulatory timelines, potential regulatory risks, logistical issues, comparator(s) availability and standards of care. Our Feasibility Experts assess the client’s needs on a country-by-country basis, in order to appropriately match studies with best sites and patient populations.
We offer a full line of Regulatory Affairs Specialist services for all levels of interest with US Food and Drug Administration (FDA) as well as European Medicine Agency (EMA) and Conformité Européene (CE Mark) submissions.
Our CRO will identify the most important Key Opinion Leaders in the US, UK, France, Netherlands, Sweden, Serbia, Croatia, Slovenia, Bosnia and Herzegovina, Montenegro, Macedonia, and Hungary for your study.
It is always valuable to have input on the study protocol from physicians who work with the study populations. Our internal and external experts can assist you with this very important stage of the study. If you need a complete study protocol written, our CRO medical experts are able to provide this service for your trial.
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