Pharm-Olam provided global project management to the sponsor involving nearly 200 sites in 25 countries in a 600 patient, ICU-based, competitive recruitment study. Pharm-Olam was responsible for reviewing all regulatory packages, global medical monitoring, training and management of all vendors, which included 5 regional CROs.
This study was originally planned to be managed by a large global CRO, however the study sponsor was not pleased with their performance from a previous study and felt that their resources were over capacity. The sponsor selected Pharm-Olam to handle global Project Management for the study and to provide regional Regulatory and Monitoring.
Pharm-Olam was responsible for site selection, regulatory and monitoring in South Africa, USA, Hungary, Spain, Georgia, Estonia, Serbia, France, and Slovakia for a total of 57 sites. The average recruitment per site was 4.1 patients (including 13 sites in the USA), compared to the 5 regional CROs that covered 14 additional countries with over 100 sites and averaged 3.4 patients per site. The sponsor’s drug later received NDA approval.
Reference from Sponsor:
“Turnaround timelines for actions were consistently achieved and Pharm-Olam’s constant communication with the global teams and Vendors resulted in a smooth execution of study and on-site activities. Senior Management and Pharm-Olam teams were available and remained flexible at all times, responding quickly to all requests to ensure customer expectations were met throughout the study.” - Associate Director, Clinical Outsourcing