Orphan, FIM, MTD
The study was having difficulty recruiting patients with 3 sites in the USA (managed by the sponsor) which randomized only 1 patient after several months of enrollment which required 20 patients.
Pharm-Olam was asked for help in enrollment and recommended 2 sites overseas in Georgia due to short regulatory review and our previous success enrolling patients there. Regulatory/Ethics services were provided by Pharm-Olam in Georgia which took 6 weeks from initial submission to final approval. We also provided Monitoring and Project Management and an initial target enrollment of 12 patients. After meeting this goal, enrollment was extended to 19 patients after the sponsor-managed sites in the USA failed to enroll any additional patients.
The study sponsor later selected Pharm-Olam to run a solid tumor study in Georgia for another compound. Pharm-Olam provided Pharmacovigilance services in addition to Regulatory, Monitoring, and Project Management for this study.