Systemic Lupus Erythematosus with Lupus Nephritis (Orphan)
Pharm-Olam was involved as a CRO with one of the largest Systemic Lupus Erythematosus global trials, with 950 patients in over 160 sites in 20 countries. The sponsor had enrollment challenges among the 6 different CROs working on the study because the protocol required SLE patients with a history of Lupus Nephritis and other criteria.
Pharm-Olam’s role in the study was to support supplemental enrollment efforts. Pharm-Olam was tasked with an initial target of 48 patients and the management of regulatory, site selection, monitoring, project management and medical monitoring in Eastern Europe. Impressed by the speed and quality of our start-up, the sponsor asked Pharm-Olam to take over the monitoring of sites in the USA and extended medical monitoring to cover Western Europe. At study completion, Pharm-Olam managed 39 sites and enrolled 137 patients.
“Pharm-Olam’s performance in meeting our dynamic study requirements was outstanding. The project was very well managed and monitored by the Pharm-Olam study team, who worked seamlessly across multiple time zones and ensured near-constant communication with our staff. The medical monitoring needs for the study were extensive and had to accommodate various national reporting requirements. Pharm-Olam’s medical team provided truly expert service and worked very professionally with our in-house Pharmacovigilance personnel.”