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.

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

Glaucoma project

GCT proudly announces the award of a multi center phase III Glaucoma project.

This project marks the 2^nd Ophthalmology project from this client; the first successful trial was performed in the Ukraine. We are excited to be working once again with this client, their belief in our capabilities to get the job done reflects well on our quality and our commitment to our clients.

The project continues to expand our growing experience in Ophthalmology making GCT one of the most experienced CROs in the region in this therapeutic area. The trial, which will run entirely in Russia, will enroll 180 patients across 7 sites.

August, 2009; St. Petersburg, Russia

International Alzheimer's program

During the Month of June Global Clinical Trials initiated work for one of the top Pharmaceutical Companies in the world, to support their global Alzheimer's program in Russia, Ukraine and Bulgaria. In all, 26 sites across these three countries were selected to take part in this phase II global program. Dr. Eugene Selivra, CEO of GCT, is excited by the opportunity to work with such a large and dynamic organization. "Though we have worked with other similar organizations this opportunity helps demonstrate our growth as a company, having been selected to manage such a significant piece of a global project. We feel very comfortable in being able to meet the needs of the sponsor and developing a long term relationship that will benefit both organizations," said Dr. Selivra.

June, 2009; Princeton, NJ, USA

Enrollment completion

Global Clinical Trials announces the completion of enrollment for two large women's health projects. During the month of May we have successfully completed enrollment of two studies in Mixed Bacterial Vaginosis / Vulvovaginal Candidiasis Infections. The first trial required 29 sites to enroll 393 patients and the second trial required 20 sites to enroll 209 patients. GCT will continue to monitor both projects through to their successful completion this summer.

May, 2009; Moscow, Russia

Industry meetings

The month of April concluded with GCT attending the 18^th Annual Partnerships Meeting in Orlando, Florida. GCT shared a booth with our US partner, ResearchPoint Global, promoting our shared capabilities to provide global trial support. During the end of March we have attended and exhibited at the 21^st Annual European DIA meeting in Berlin, Germany.

The meetings gave us the opportunity to promote our services to both current and potential clients and catch up on Industry trends and changes. Both meetings proved to be successful and well attended. Our next meeting will be at the end of May for the ASCO meeting in Orlando, Florida. If you would like to meet with us at any meeting please submit your request. We look forward to seeing both old and new clients at ASCO.

April, 2009; St. Petersburg, Russia

Previous postings

• Oncology program completion
• New project in Russia
• Oncology study in Ukraine
• FDA audit
• Global Clinical Trials makes management changes
• GCT expands Drug Storage and Central Pharmacy capabilities
• Investigator Meetings in September
• Enrollment completed ahead of schedule

Older postings are in the archive

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