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Pediatric Asthma (Rescue) Pharm-Olam rescued this study by recruiting 197 patients from 12 sites in Poland in 2.5 months, allowing our sponsor to meet their enrollment target on time. This Phase III double blind, placebo controlled study used a metered dose inhaler once daily for 12 weeks in treatment of children with persistent asthma. POI selected the sites, recruited patients, and handled regulatory affairs for the sponsor. "The recruitment challenges were considerable based on the required age and inclusion/exclusion criteria of participants. In order to obtain the necessary number of patients, we asked POI to basically double their enrollment numbers half way through the trial and still meet the original times. The team successfully met this challenge." Manager, Respiratory Medicine (Pediatric Asthma Study)
Rhinoconjunctivitis (Cat Allergy) Pharm-Olam conducted a rhinoconjunctivitis study for a desensitizing vaccine using 2 sites in Germany. Recruitment closed on time, with 88 randomized patients in 22 weeks. This study involved multiple cohorts, escalating doses, and Late-Phase Allergic Skin Reaction (LPSR) measurement. Services provided to the sponsor included regulatory, project management, monitoring, data management, and biostatistics.
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