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 St. Petersburg and Moscow, Russia; Sofia, Bulgaria; Bucharest, Romania and Kiev, Ukraine.

DIA in Washington

At the recent 46^th 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

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

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

BizAcumen publication and upcoming DIA meeting

Global Clinical Trials, LLC was featured recently in the BizAcumen Report on Contract Research and Outsourcing. The article highlights our growth over the last few years, providing detailed insight into our success. It demonstrates our position as one of the most experienced and customer focused CROs, capturing our regional focus and multi-therapeutic capabilities.

See more information about this report or request your copy.

In other news, our Vice President of Business Development, Richard Leach, has been selected to chair a session at the upcoming United States DIA held in Washington this coming June. The session that Mr. Leach has been asked to chair will highlight the value of regional CROs in performing global projects.

He will be joined by several other speakers from both Pharmaceutical and Biotech organizations that have experience with the Regional Service Provider (RSP) model. Mr. Leach will provide his own insights on the usage of the model, as learned from his own successful implementation. It is widely accepted that working with regional CROs will save you both time and money over the "overhead intensive" and more expensive Global CROs. The challenge, however, is the management of the process and the construction of a unified team working together across country/company lines. This session will discuss the many ways our speakers have addressed these challenges and were able to complete their projects on time and under budget, sharing their various stories of success and tribulation.

November, 2009; Princeton, NJ, USA

Women's health program

In the month of October GCT has accomplished the selection of 20 sites in Russia for an extensive women's health program for a US-based Pharmaceutical Company.

This milestone marks five years with this Company being our oldest Sponsor, with more than fifteen hundred patients enrolled in various studies.

We are looking forward to continue this collaboration, which has already greatly contributed to the mutual success of both Companies.

October, 2009; Princeton, NJ, USA

Expansion to South America

Global Clinical Trials is pleased to announce our expansion into Argentina, South America.

Argentina has been one of the fastest growing countries in the region for clinical research. In 2008 Argentina harmonized its clinical trial regulatory requirements to conform with international best practices making the country more desirable for clinical research and bringing it in line with global programs.

“Our clients help provide direction on where we need to be.” Said Dr. Jeffrey Apter, President of GCT. “Based on client feedback and requests they help to identify the countries with the best the enrollment opportunities and Argentina fits that bill. The sites are experienced and the patients are motivated to participate creating an excellent environment for clinical research.”

Argentina provides our clients a location in the Southern Hemisphere where they can be confident in the professionalism and experience of the sites.

September, 2009; Princeton, NJ, USA

Previous postings

• Glaucoma project
• International Alzheimer's program
• Enrollment completion
• Industry meetings
• Oncology program completion
• New project in Russia
• Oncology study in Ukraine
• FDA audit

Older postings are in the archive

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