Pharm-Olam conducted a phase II study in pain treatment after open abdominal surgery with 14 sites in three Eastern European countries. The study design was randomized, double-blind, with placebo and active controls, to find optimal dose and evaluate efficacy.
We provided Regulatory, Monitoring, Project Management, Data Management, Pharmacovigilance, and Medical Monitoring services. Pharm-Olam was able to meet the enrollment goal 1 week early despite changes in study design and delays in IMP shipments due to flight cancellations from a volcano eruption in Iceland. The original target was 460 randomized patients and Pharm-Olam met this goal early and enrolled an additional 36 patients to complete the study.