Site take over and supporting
The sponsor of this Phase III study in Crohn’s disease required 595 patients globally which was conducted by several regional CROs involving over 170 sites in 28 countries. The study sponsor was not satisfied with the performance of their Eastern European CRO and chose to transfer responsibility to Pharm-Olam.
The sponsor’s original plan was to recruit 300 patients with 66 sites in 9 countries. The original CRO had selected 40 sites in Russia, Ukraine, Belarus, and Czech Republic. After problems with regulatory delays and drug importation which slowed recruitment, the sponsor turned to Pharm-Olam after only 83 patients were recruited in 3 months.
Pharm-Olam resolved the problems with drug shipments, and recommended sites in Poland, Georgia, and Bulgaria where Pharm-Olam handled all Regulatory Submissions, Monitoring, and Pharmacovigilance. Pharm-Olam was able to meet the tough recruitment deadline 1 week early, recruiting a total of 234 patients in 4 months using 50 sites and monitored at total of 317 patients. The top recruiting countries for this study were Czech Republic (79), Russia (77), and Poland (51 with an average recruitment per site of 6.3 patients. The data from this study was later used to support a successful FDA application.