Glabellar Lines (Phase II)

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:

• Delivered 176 patients, 16 over the originally requested amount, 5 weeks ahead of schedule
• Managed the percentage of dropouts to be only 1%
• Locked the database 2.5 months ahead of schedule
• Supported a intense sponsor audit with no significant findings
• Completed the study (files returned to the Sponsor) 4 months ahead of schedule