US group Coté Orphan is expanding into the contract research field to help clients navigate the clinical trials process for orphan drugs “through the lens of regulatory affairs”. 

The company has now launched a Clinical Research Organisation (CRO) service that will design clinical trials for orphan drugs to fit the current regulatory frameworks set by the Food & Drug Administration and European Medicines Agency.

“By designing trials processes that are already in compliance with current regulations, we are helping to drastically cut the time to market for these types of drugs,” said Timothy Coté, the group’s chief executive, and one-time Director of the FDA’s Office of Orphan Product Development.