Pharm-Olam International - A Contract Research Organization

Crohn's Disease (Rescue)

The study sponsor required 595 patients and selected several regional CROs involving over 170 sites in 28 countries. After their Eastern European CRO experienced problems with regulatory delays and drug importation, the sponsor turned to Pharm-Olam for help after only 83 patients were recruited in 3 months.

Pharm-Olam took over responsibility of existing sites in Eastern Europe, resolved the shipment problems and initiated additional sites in 3 other countries. Pharm-Olam met the recruitment deadline 1 week early, recruiting 234 patients in 4 months. Top Recruiting Countries: Czech Republic (79), Russia (77), Poland (51).

Crohn's Disease

Pharm-Olam recruited 183 patients in 28 sites within Eastern Europe over a period of 8 months in a Crohn's study

to prevent flare while allowing steroid withdrawl in steriod dependent patients. The patient recruitment target was exceeded by 43 patients.

"The most impressive part about working with POI is that they can be trusted to deliver what they promise. Before POI, I had not worked with a CRO that was able to predict enrollment any better than the investigators(which is poorly). We performed 4 studies with POI. Each finished on-time (or early). Their efficiency allowed us to confidently report results when promised."

Sr. VP of Clinical Operations - Crohn's and UC Studies

Ulcerative Colitis (Rescue)

This phase II study was in patients with active, distal ulcerative colitis and involved dose escalation, double-blind, placebo aspects to test of the efficacy and safety of enema.

Pharm-Olam was asked to rescue this study ongoing at in France and Belgium. We recommended a country in Eastern Europe to the sponsor and began regulatory submission promptly. Our goal was 20 patients in 12 weeks of enrollment with 5 sites. All patients were enrolled in just 8 weeks.

FDA Guidance Documents Related to Gastroenterology


		Irritable Bowel Syndrome -- Clinical Evaluation of Products for Treatment

Gastroenterology Studies

Abdominal Infections
Chemo-Induced Nausea
Crohn's Disease
Gastritis
Hepatic Impairment
Irritable Bowel Syndrome
Liver Cirrhosis
Traveler's Diarrhea
Ulcerative Colitis

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)