Pharm-Olam International - A Contract Research Organization

Coronary Artery Disease

Pharm-Olam's enrollment target of 200 patients for a phase II coronary artery disease study in the North America and Eastern Europe was met three weeks before schedule. The sponsor extended the recruitment and an additional 195 patients were recruited in 5 weeks.

Pharm-Olam provided full service to the sponsor including: regulatory, site selection, project management, monitoring, pharmacovigilance, and data management.

The sponsor awarded Pharm-Olam another coronary artery disease study involving 137 patients where the enrollment target was achieved 3 weeks early and enrolled 17 additional patients.

Thromboembolism

This Phase 3 study for patients with thromboembolism following hip surgery was conducted with 26 sites in Eastern Europe. Over 950 patients were required globally, and Pharm-Olam was given a target of 345 patients. We recruited 400 patients staying ahead of schedule through the duration of the trial before the global target was achieved.

Pharm-Olam performed regulatory, site selection, project management, and monitoring services.

Angina

This phase II angina study involved 30 sites across Eastern Europe. 100 patients were recruited in 4 weeks (following regulatory approval). Data from the trial needed to be queried by a DSMB before recruitment could resume. Because the drop out rate was lower than expected, 37 patients were recruited over the target.

Cardiology Studies

Angina
Atrial Fibrillation
Blood Loss
Chronic Heart Failure
Congestive Heart Failure
Coronary Artery Disease
Hyperlipidemia
Imaging Studies
Intermittent Claudication
Pacemaker
Pulmonary Hypertension
Myocardial Infarction, Acute
Stent
Thromboembolism
Ventricular Dysfunction

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)