Global Clinical Trials, LLC is a Contract Research Organization with operations in Russia, former Soviet Republics and Eastern Europe. GCT is headquartered in Princeton, NJ, USA with full service offices in
New projects, team expansion
Alexandra Zaichenko in her new office
GCT was awarded an ophthalmology trial in dry eye syndrome which will randomize fifty patients in Russia. The trial is scheduled to be launched in early October, 2010.
GCT was awarded a phase II trial in Hematology to be conducted in 5 sites across Russia. The project is planned to be submitted to the regulatory authorities during the 1st week of September, 2010.
GCT is proud to highlight another addition to the GCT team. Alexandra Zaichenko, M.Sc., joined GCT as Director of Business Development. Alexandra comes to GCT with 6 years of experience in the Pharmaceutical industry serving both Pharma and Biotech Clients. Prior to GCT she was in responsible for global business development for medium sized international CRO in Russia.
August 2010; St. Petersburg, Russia
July news
Global Clinical Trials recently completed enrollment of 185 patients for an ongoing Glaucoma trial one month ahead of schedule. In meeting the needs of the client, GCT leveraged their relationships with the sites to maximize their individual patient data bases and exceed the enrollment goals of the trial. The project is now well positioned to complete early and stay ahead of their development schedule.
GCT was selected to perform regulatory services and clinical support for an international project requiring 5 sites in the Russian Federation. This multi-national phase III trial in Alzheimer's Disease is scheduled to begin recruitment this Fall.
July 2010; St. Petersburg, Russia
DIA in Washington
Plenary session
At the recent 46th DIA in Washington, D.C., Global Clinical Trials was more than just another exhibitor. Vice President Richard Leach was selected by DIA to chair a session titled: "Risks and Benefits in Utilization of the Regional Service Providers (RSP) Model when Conducting Global Programs".
Through the use of case studies and the interaction of experts from both CROs and Sponsors, they presented the attendees with a balanced perspective on the real challenges and benefits of this Global model.
When asked about the potential value in performing trials using the RSP model Mr. Leach explained, "Clinical Research Today is a global endeavor requiring expertise in study management and coordination in countries throughout the world. To address this growing need many sponsors have elected to work with large global CROs with global offices and incredible infrastructure driving their rates higher without necessarily adding value to the project. Think of the benefits of paying local rates to experienced regional service providers who have the specific expertise of managing your trial across a few countries where enrollment is at a premium. The potential in savings can be quite serious".
If you would like to receive a copy of the presentation please e-mail rl@gctrials.com and a PDF version will be forwarded.
June 2010; Princeton, NJ, USA
Ophthalmology trial enrollment
Global Clinical Trials would like to congratulate Ophthalmology sites in our current glaucoma trial. The study which was planned for 6 months enrollment has already met 50% of it's enrollment goal of 180 patients after only one month.
We look forward seeing our Investigators at the upcoming 16th International Ophthalmology Congress "The White Nights", which will take place in Saint Petersburg, Russia, May 31st through the 4th of June. GCT is a proud sponsor and informational partner of the Congress for the last 3 years.
April, 2010; St. Petersburg, Russia
EPC Publication
GCT is proud to announce that Dr. Adrian Iancu, General Director of our Romanian Office, has placed an article (PDF) in the current March Edition of EPC Journal (European Pharmaceutical Contractor). In this article Dr. Iancu researches the many benefits associated with performing clinical trials in Romania. Dr. Iancu has been with GCT since 2007 having accumulated more than 11 years experience performing clinical research in Romania.
March, 2010; Bucharest, Romania
Investigator Meeting
CRF completion training
GCT has set up and managed an Investigator Meeting in St. Petersburg for a 180 patients phase III Glaucoma project.
An important milestone in the study, the event has been visited by Russia's top opinion leaders in Glaucoma, which allowed direct contact between the Sponsor, Investigators and GCT teams facilitating open dialog and productive cooperation.
February, 2010; St. Petersburg, Russia
First patients in Alzheimers' program
Microscopy image of a neurofibrillary tangle, conformed by hyperphosphorylated tau protein
Global Clinical Trials is proud to announce the first enrolled patients for an International Alzheimers' program. This program, from one of the largest pharmaceutical companies in the world, is planned to enroll more than 300 patients at 27 different sites across Russia, Ukraine and Bulgaria.
The CEO of Global Clinical Trials, Dr. Eugene Selivra, expressed strong support for the project team. "This project team was tasked with starting up a challenging international project within a very narrow window to get the first patient enrolled by the end of the year. The teams customer focus, regulatory expertise and attention to detail made this possible and I congratulate the team in their achievement."
December, 2009; Moscow, Russia
Previous postings
- BizAcumen publication and upcoming DIA meeting
- Women's health program
- Expansion to South America
- Glaucoma project
- International Alzheimer's program
- Enrollment completion
- Industry meetings
- Oncology program completion
Older postings are in the archive
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