Case Study - Endocrinology

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Type II Diabetes

Pharm-Olam has completed enrollment of a type II diabetes study involving over 240 patients with sites in India and the USA. 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 POI 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

Download Endocrinology Brochure

Studies include

Acromegaly
Diabetes, Type I
Diabetes, Type II
Diabetic ucler
Hypogandism
Short Cervix

Cost Effective Diabetes Coverage

The table below shows examples of the cost-effective coverage Pharm-Olam can provide based on diabetes prevalence rates and population of where our offices are located. Many areas have underreported cases and competition for patients also varies, so contact us conduct a free feasibility study that is specific to your protocol to use in your resource planning.

Prevalence Data Type 2 Diabetes Mellitus	Metro Population (millions)	Pharm-Olam Related Experience
Mexico Mexico City (Age 20+) 14.9% 1	Mexico City 18.4	Our Clinical Operations Manager at our Mexico City office has served as an investigator on 4 diabetes mellitus studies, Phase II-IV. Monitors with diabetes mellitus experience are available.
India Bangalore (Age 20+) 12.4% 2 Chennai (Age 20+) 14.3% 2 , 15.5% 3	Bangalore 6.58 Chennai 7.3	One of our PMs at our Bangalore office has experience in adult and pediatric diabetes mellitus studies. Monitors with diabetes mellitus experience are available.
Brazil Sao Paulo (Age 30-69) 12% 4	Sao Paulo 19.1	Our office in Sao Paulo has monitors with experience in diabetes mellitus, along with a full time regulatory specialist to ensure a smooth approval process.
United States (national) Mexican Americans (Age 20+) 25.7% 1 African Americans (Age 20+) 19.8% 1 Non-Hispanic Whites (Age 20+) 12.7% 1	Houston 4.7 (25% African American, 37% of the total population is Hispanic)	POI's global headquarters is located in Houston were we have several clinical staff with clinical trial experience in diabetes mellitus. POI also has regional staff in other areas with high levels of diabetes, including Dallas and San Antonio.
Europe (national Age 20-79) 5 Germany 11.8% Bulgaria 10.1% Hungary 9.8% Czech Republic 9.7% Romania 9.4% Poland 9.1%	Munich 1.7 Sofia 1.1 Budapest 2.1 Prague 1.2 Bucharest 2.0 Warsaw 2.0	POI has talented project managers and monitors at our local offices throughout Western and Eastern Europe to provide cost effective coverage. Many have prior experience with both type 1 and type 2 diabetes.

Sources
1. Incidence and prevalence of diabetes mellitus in the Americas Barcelo, Rajpathak PAHO 2001
2. India MoH 2007 Prevalence Report – Development and Updation of the Diabetes Atlas of India
3. Type 2 Diabetes in India: regional disparities – British Journal of Diabetes and Vascular Disease Vol 7 Issue 1, 2007
4. Prevalence of diabetes mellitus and impaired glucose tolerance in the urban population aged 30-69 years in Ribeirão Preto (São Paulo), Brazil. (1988)
5. EU prevalance data 2006. International Diabetes Federation Diabetes Report 2008

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 Poland. 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.