Case Studies | EGeen International Corporation: Full-service CRO for Speed, Quality and Cost

Case Study: Psychiatry

In a Phase II schizophrenia study, EGeen was in a competitive enrollment scenario with a larger pan-European CRO operating Western and Eastern European countries. Engaging only 5 sites in Estonia and Latvia, EGeen enrolled 120 patients via close collaboration with hospitals compared to the competitor’s 10 patients during the same enrollment period of 5 months. The study has been successfully concluded on time to enable the Sponsor to raise the next round of financing over 30 million euros.

Case Study: Oncology

In two head and neck cancer phase III trials, EGeen was brought in to rescue the study. Despite no precedent for similar trials in drug/device combinations in our territories, we were able to obtain regulatory approvals and initiate 14 sites within 4 months. In the first phases of the studies, EGeen was able to complete recruitment of 75 patients in 6 months in Latvia, Lithuania and Ukraine versus 20 patients in 20 months across the world by a global CRO prior to our involvement. Through proactive project management and by using a variety of creative recruitment strategies, the project team met the recruitment and study goals. The Sponsor subsequently extended the contract to the next phase of this pivotal study for an FDA approval of the drug-device combo. Additionally, the Sponsor awarded the two Phase I trials in breast and pancreatic cancer indications.

Case Study: Oncology Diagnostics

In a phase III study for a novel oral cancer diagnostics, EGeen was asked to screen 1,600 subjects to select 400 subjects eligible for testing of the diagnostics in development. Due to the extent of EGeen’s network in Ukraine and project management capabilities, EGeen was able to successfully conclude the program within 4 months.

Case Study: Autoimmune Disease 1

In multiple sclerosis Phase III trial, EGeen was able to complete recruitment of 100 patients in 8 months in Baltics and Ukraine versus 60 patients in rest of the world by a much larger CRO.

Case Study: Autoimmune Disease 2

In ulcerative colitis Phase III trials, EGeen was brought in to expand the study by a US specialty pharma. EGeen was able to obtain regulatory approvals and initiate 9 sites in Ukraine within 3 months, which subsequently recruited over 120 patients in 9 months. Subsequently, the Sponsor extended the studies in other Eastern European countries (Estonia, Latvia, Lithuania and Romania) and Turkey with additional 26 sites, which recruited over 240 patients within 10 months.