Pharm-Olam International - A Contract Research Organization

Type II Diabetes

Pharm-Olam completed enrollment of a type II diabetes study involving over 240 patients with sites in India and North America. Pharm-Olam provided assistance with IND preparation and other regulatory services, project management, monitoring, data management, and pharmacovigilance.

"We are now 3 months into the enrollment phase of the diabetes trial and we are very happy with the partnership we have made. Pharm-Olam organized and ran an excellent investigator meeting in India, secured the necessary regulatory approvals,

engaged highly qualified investigators, set up the database, depot and lab arrangements as quickly and efficiently as we have seen. I personally spent a week at the Pharm-Olam India office in Bangalore working with the staff there and I could not be happier with the professionalism and level of commitment I found to our project."

Senior Director Clinical Operations

Uterine Fibroids in pre-menopausal Women

Pharm-Olam conducted a proof of concept Phase Ib study involving 30 patients with uterine fibroids at a Phase I unit in Eastern Europe. The 3 month duration of treatment study included safety, PK, dose titration and efficacy endpoints.

The results were submitted to the FDA in an IND. From the initiation of the phase Ib study to start of phase II, all were accomplished in one year.

FDA Guidance Documents Related to Endocrinology


		Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Recommendations for Clinical Evaluation

Endocrinology Studies

Acromegaly
Diabetes, Type I
Diabetes, Type II
Diabetic Ulcers
Diabetic Nephropathy
Growth Hormone Therapy
Leiomyomata
Hypogonadism
Short Cervix
Uterine Fibroids

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)