Pharm-Olam International - A Contract Research Organization

Acute Myeloid Leukemia (Rescue, orphan, FIM, MTD)

The study was having difficulty recruiting patients with 3 sites in the USA (managed by 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 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 for another compound. Pharm-Olam provided pharmacovigilance services in addition to regulatory, monitoring, and project management for this study.

Anemia (Rescue, pediatric)

The sponsor required 58 patients for their double-blind, efficacy study in pediatric hemodialysis patients receiving Epoetin. The sponsor had very poor recruitment with the 8 USA sites they chose and managed.

Pharm-Olam was approached to rescue this study and set up 16 sites in Latin America and Eastern Europe. We performed all the regulatory, monitoring, and project management for the ex-USA sites. Pharm-Olam randomized 50 patients, with the sponsor recruiting the remaining 8 patients.

By using the sites set up and initiated by Pharm-Olam, the sponsor was able to recruit the required number of patients within the desired timelines. They were very happy with the standard of work provided, and were particularly impressed by the quality of the data.

Essential Thrombocythaemia (rescue, orphan)

The sponsor an essential thrombocythaemia study did not like the performance of their CRO (a top 5 company) and selected Pharm-Olam for a complete handover of a phase IIIb and phase IV registry in the same indication.

Patients could not have been previously treated with a cytoreductive agent and or have taken on any anti-coagulant and anti-aggregant therapies.

The phase IIIb study involved 14 countries in Western and Eastern Europe with 22 sites and 180 patients. The phase IV registry study involved 146 sites in 13 countries. 3,668 high-risk ET patients taking cytoreductive therapy were enrolled in 18 months.

The sponsor was pleased with our performance and has since awarded Pharm-Olam a third study in pediatrics.

Hematology Studies

Anemia
Anemia in Chronic Kidney Disease Patients
Anemia following Chemotherapy
Essential Thrombocythaemia
Graft Versus Host Disease
Hemodialysis
Leukemia, Acute Myeloid
Lymphoma, Cutaneous
Multiple Myeloma
Myelofibrosis
Thromboembolism

Argentina (Buenos Aires), Belarus (Minsk), Belgium (Brussels), Brazil (São Paulo), Bulgaria (Sofia), Canada (Toronto), Croatia (Zagreb), Czech Rep. (Prague), Georgia (Tbilisi), Germany (Munich), Hungary (Budapest), India (Bangalore), Italy (Milan), Kazakhstan (Almaty), Mexico (Mexico City), Poland (Warsaw), Romania (Bucharest), Russia (Moscow, St. Petersburg, Novosibirsk), Serbia (Belgrade), Spain (Madrid), South Africa (Johannesburg), Ukraine (Kiev), United Kingdom (London), United States (Houston, Princeton, Research Triangle Park)