Pharm-Olam was selected to provide Project Management, Monitoring, and Regulatory services for the sponsor of a Phase II dermatology study in glabellar lines. The recruitment timelines were very short (160 patients within 4 months, 8 sites). The challenges encountered in this study included performing SEV and submission in 3 weeks to ensure prompt recruitment and then to manage the high recruitment rate at each site.
Upon study completion Pharm-Olam: