Case Study: Onychomycosis Phase II

A leading pharmaceutical company specializing in dermatology approached Novella Clinical to conduct a large Phase II onychomycosis study involving approximately 440 to 460 patients across 25 US and Canadian sites. Novella’s Dermatology Division was selected because of its reputation as a provider of quality clinical trial management services in addition to its proven patient recruitment process with a record of rapid enrollment for specialty treatment populations.Based on the sponsor’s historical data and prior experience with onychomycosis,the sponsor estimated that full enrollment of 460 subjects should take approximately 52 weeks. Novella’s analysis indicated that with a robust Recruitment Management Plan (RMP), enrollment of the minimum number of subjects could be completed in as little as 33 weeks, saving substantial time and money.