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 Russia, Ukraine, Belarus and Czech Republic, resolved the shipment problems and initiated additional sites in Poland, Georgia, and Bulgaria. 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).

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Studies include

  • Crohn's Disease
  • Gastritis
  • Hepatic Impairment
  • Liver Cirrhosis
  • Irritable Bowel Syndrome
  • Reflux Esophagitis
  • Ulcerative Colitis
Crohn's Disease  

Pharm-Olam recruited 183 patients in 28 sites within Hungary, Czech Republic, Poland , and Bulgaria 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)


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