Our initial goal was to enroll 50 patients over a period of 6 weeks using 5 sites in an European country. Pharm-Olam achieved this goal 2 weeks early and the sponsor extended enrollment.

Over a 5 month period Pharm-Olam enrolled 242 patients before the total target was achieved globally. In the end, Pharm-Olam enrolled over 60% of the patients with less time and fewer sites.

The study drug later received marketing authorization.

POI 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). Challenges of 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.
• 176 patients recruited instead of 160, 5 weeks ahead of schedule
• Percentage of dropouts was only 1%
• DB lock done 2.5 months in advance ahead of schedule
• Study audited by sponsor with no significant findings
• The study was completed (files returned to the Sponsor) 4 months ahead of schedule.