Case Study 2
Hepatic Encephalopathy Trial
A US-based pharmaceutical company had partnered with a Global CRO to conduct a study with severe population of patients with hepatic encephalopathy. The Global CRO tried to add Russia to the slow enrolling trial since the other countries were not meeting enrollment goals. The Global CRO, lacking a significant physical presence in Russia, was on schedule to take more than 8 months to obtain regulatory approvals. The client decided to have ClinStar rescue this study in order to meet their end of year timelines. ClinStar received all approvals within 1.5 months and enrolled all 80 patients by the end of the year which allowed the Sponsor to close the enrollment that had been lasting for several years.
The Clinical Project Manager wrote to ClinStar. . .
"I mean these words…the ClinStar team has been the absolute BEST I have worked with! I hope that I will be on studies that have an international component as I will STRONGLY recommend ClinStar to work with! You and your team have been PHENOMENAL!!!!"
ClinStar enrolled 80 patients within 3 months Without ClinStar it would have taken the client 13 additional months to enroll the target number of patients.
