Antifungal drug in gynecology

Background: Our company was involved in the organization of a phase III clinical trial of an antifungal medicine in patients with candidiasis vulvovaginitis.

About a trial: Our services for the project included biostatistics, selection and monitoring of sites, data management, submission and programming of electronic diaries (ePRO) and preparation of the final report. An additional request of the Sponsor was the organization of medical monitoring, including approval of subject inclusion and evaluation of deviations from the study protocol.

Challenges: The Client had very strict requirements to the timing of the study, so at the stage of selecting centers we were very careful about the speed of enrollment announced by the centers. As a result, 220 subjects in five sites were included in the study in one month.