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