Pharm-Olam International - A Contract Research Organization

Rheumatoid Arthritis (Rescue)

The sponsor of a first-in-man, biological was having difficulty recruiting patients with another CRO that recruited only 21 patients with 12 sites in the United Kingdom.

Pharm-Olam was asked to rescue to the study and quickly started regulatory approval in Eastern Europe. Pharm-Olam delivered 98 out of the required 119 patients, more than 75% of all patients, despite the fact that the other CRO had more sites and 6 months longer to recruit patients.

Systemic Lupus Erythematosus (Rescue)

Pharm-Olam was approached for supplemental enrollment with an initial target of 48 patients and the task of handling regulatory, site selection, monitoring, project management and medical monitoring in Eastern Europe.

Recruitment was difficult because the protocol required SLE patients with a history of Lupus Nephritis and other criteria. 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. In the end Pharm-Olam randomized 137 patients allowing global enrollment targets to be achieved.

"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 of the study were extensive and had to accomodate various national reporting requirements. Pharm-Olam's medical team provided truly expert service and worked very professionally with our in-house Pharmacovigilance personnel."

Executive VP and CMO and VP of Regulatory and Clinical Operations

FDA Guidance Documents Related to Inflammation


		Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) Systemic Lupus Erythematosus --Developing Drugs for Treatment

Rheumatology Studies

Arthritis, Psoriatic
Arthritis, Rheumatoid
Epicondylitis, Acute Lateral
Epicondylitis, Chronic
Gout
Osteoarthritis
Systemic Lupus Erythematosus

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)