Pharm-Olam rescued this study by recruiting 263 children (age 6-11 years) across 10 centers in Poland in two seasons. The Phase III trial assessed the efficacy and safety of oral compound tablets in pediatric subjects for treatment of seasonal allergic rhinitis. Pharm-Olam was the highest performing enroller out of several competing CROs. Data from this study was used to support successful US NDA approval for pediatric indication.
“By the end of the study Pharm-Olam was the highest recruiter with 263 randomized patients. In fact, out of 15 countries participating in the study, Pharm-Olam recruited almost 30% of all patients. The patient data collected from Pharm-Olam sites was of high quality with less than 2 queries per randomized patient.” - Study Sponsor Manager