Post-Operative Pain

The Sponsor’s hemorrhoidectomy study with another CRO was struggling with recruitment at 9 United States based sites. Pharm-Olam was asked to help with enrollment for this dose finding study with multiple cohorts and randomized 63 patients in 16 weeks (over 60% of total) with only 3 sites in Eastern Europe and less time to enroll.

Impressed by our performance the sponsor awarded their entire Phase III study to Pharm-Olam. We provided a full service solution, including Pharmacovigilance, Medical Monitoring, and Data Management (EDC). The Sponsor had very aggressive timelines for set up and recruitment which took place during the holiday season. 190 patients were randomized in 17 weeks at 12 sites in 3 countries in Eastern Europe. The study drug later received US NDA approval for post-surgical pain.

“Pharm-Olam performed a special population phase I study and pivotal phase III surgical analgesic study in Eastern Europe for which they provided full service support. The studies were completed on time and on budget. Each project was very well managed by their study team and their communication with our internal teams was excellent.” - Chief Medical Officer