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May 19, 2017
GCT is proud to announce that Phase II clinical trial was successfully completed!
Last week Dr. Eugene Selivra, CEO, and Dr. Alexey Vinogradov, Project Manager, visited investigator meeting in Sochi, Russia devoted to the successful Phase II Multiple Sclerosis project completion. During the formal part of the meeting an overview of promising study results was given by the Sponsor and a dynamic discussion on the future application of the study drug took place. After the official part was over, all participants proceeded to a lavish gala-dinner organized by the Sponsor to celebrate project success. Informal and very animated conversations continued, revolving around current standards of care, breakthrough therapies and market potential for the studied product.
April 12, 2017
As the start-up stage of an observational infant study is actively progressing, our multinational study team has attended a project-specific training held in Budapest by our colleagues from MAPI Group. GCT clinical department members from Russia, Ukraine and Hungary gathered to hold discussions on protocol-specific questions, study timelines and milestones overview, and a round table on enrollment strategies and investigator motivation tools.
The study is a follow up to an international Phase III clinical study in pre-term delivery which GCT is responsible for in CEE countries. The Sponsor for both projects has been our long-term partner, awarding studies to GCT since 2004. We believe this to be a perfect demonstration of the high quality of our work which maintains the trust of our clients for years and makes 80% of our business repeat.
April 11, 2017
GCT Russian team has performed all close-out visits for a double-blind multicenter placebo-controlled study of treatment naïve patients with relapsing-remitting multiple sclerosis. This Phase II study was conducted in Russia with participation of 21 sites which enrolled 227 subjects within 9 months.
For this project GCT provided a full cycle of services: project management, clinical monitoring, regulatory support, drug supply management, local safety reporting, site contracting and payments, central laboratory oversight, data management and statistical analysis.