Cerba Research performed a randomized, double-blind, placebo-controlled, trial to evaluate the efficacy and safety of a new therapy for post-exposure prophylaxis of covid-19 and other viral respiratory illnesses (vri)
The challenge was mainly due to the Covid-19 outbreak, as a flexible and quick approach was required for every aspect of the trial. New assays needed to be developed despite stability and testing information not being complete. Protocol changes were introduced during the study set-up, due to new FDA requirements. Shipments needed to be turned around quickly upon the sponsor’s “Go” decision. Multiple last-minute changes occurred.
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