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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.
March 29, 2017
A leading Russian pharmaceutical company appointed GCT as the CRO of choice for managing their government-sponsored program aimed at bringing a generic inhalational anaesthetic to the local market.
This Phase III multi-center double-blind study is to be conducted in patients undergoing abdominal surgery and is currently in final stages of the Ministry of Health review.