Pharm-Olam was contracted to perform and manage all aspects of a phase I/II study to evaluate the PK response of the study compound implanted in patients with Acromegaly. The study was conducted in 5 sites in Russia and Bulgaria. Pharm-Olam provided a full-service solution that included Data Management, CRF development, Clinical Monitoring, Project Management, Safety Monitoring, and Medical Writing.
With the approval of the sponsor, Pharm-Olam enrolled 4 patients over the initial target and randomized 34 patients. The sponsor later awarded Pharm-Olam their Phase III Acromegaly study and an extension study.