Global Clinical Trials (GCT) is a premium contract-research organization (CRO) supporting Phase I-IV clinical studies and post-marketing activities for international and local Big Pharma, small and medium-sized biotech enterprises, groups and funds, as well as large universities and institutions.
The company was established in 2001 by experts in the pharmaceutical industry. Headquartered in Princeton, USA, GCT offers both local and global support in the USA, Europe, and Asia. GCT established 8 operational offices across the globe offering full-service clinical trial solutions in Bulgaria, Czech Republic, Hungary, India, Kazakhstan, Moldova, Poland, Romania, Russia, Slovakia, Ukraine, and the USA.
The GCT team now consists of over 100 full-time clinical research professionals. We guarantee a tailored approach for every project and provide our clients with both standalone services as a functional service provider (FSP) and excellent full-service support during study start-up, active project phase and study close-out. We stay fully compliant with the latest GCP, EMA and FDA guidelines, and local regulations. Please see the full list of services.
GCT has been a reliable partner for many local and international pharmaceutical and medical device companies. Our professional staff have been sharing their unique experience and utilizing established contacts with the KOLs. We have our Quality Management System based on the internally developed Standard Operational Procedures (SOP) and have successfully passed more than 65 regulatory inspections and external audits, including the ones by U.S. Food and Drug Administration (FDA).
GCT owns a 400 sq. m. (4300 ft.sq.) Drug Storage and Distribution facility in St. Petersburg, Russia. It is compliant with international standards, which has been confirmed during multiple audits. The depot is fully equipped, disaster protected and supports multiple modes of storage - ambient, climate-controlled, refrigerated and frozen. We provide packaging, labeling and assembly of the investigational product services, and laboratory kits and biosamples management.
Our high standards of service and customer satisfaction are guaranteed: more than 80% of our business comes from repeat clients. Furthermore, the number of our clients worldwide has increased dramatically in recent years.
We actively participate in specialized industry events worldwide. Since 2006, GCT is also an Exclusive Partner of “The White Nights” International ophthalmology congress in Russia.
Follow the GCT company page for more information about the work we do.
An office in St. Petersburg, Russia, is established
GCT initiates a first local clinical trial
US headquarters opened in Princeton, NJ
Clinical operations office in Bulgaria established
GCT becomes an exclusive partner of “The White Nights” international ophthalmology congress in CIS
New offices in Ukraine and Romania are set up
FDA inspectors visit GCT facilities in Russia while examining investigative sites participating in a GI phase III project; no major findings reported
Expansion to Hungary and the Czech Republic
GCT pioneers in a Russian government-sponsored pharmaceutical clinical development program
GCT Ukrainian office successfully passes a regulatory inspection by local authority (Ministry of Health)
Expansion to the Slovak Republic
New office in Budapest opened
GCT Russian office successfully passes a regulatory inspection by local authority (Federal Healthcare Surveillance Service)
Expansion to Poland — new office in Warsaw
Expansion to India — new office in Mumbai
Expansion to Moldova
Jeffrey Apter, MD, President
With 30+ years of executive oversight, management and conducting experience in over 300 clinical trials in Eastern Europe, Russia and USA, 40+ years of practice in Psychiatry and Neurology, and dozens of publications, Dr. Apter has internationally renowned expertise in clinical research.
Being the founding member of numerous professional associations and research institutions, he has the knowledge, authority and enthusiasm to navigate clinical research programs in various regions and therapeutic areas.
Eugene Selivra, MD, CEO
Having received his medical degree from Pavlov Medical School in St. Petersburg, Russia in 1985 and followed by heading a department at the prestigious Bekhterev Psychiatric Institute, making over 10 publications in CNS clinical research, Dr. Selivra has 25+ years of experience conducting and managing multi-therapeutic trials in US, Europe and Russia.
As a recognized expert in CNS field he retains a solid authority within clinical research community in the region.
Mission & Vision
Our priority is to provide our clients with the highest quality of clinical data in the shortest period of time while making the most of the opportunities offered by the regions we cover: loyal and interested patient population, motivated investigators, local legislation aligned with international standards, and competitive pricing.
We wish to unlock the region’s potential both for local and international Sponsors and thus offer our unparalleled expertise in cooperating with the national regulatory authorities, tackling logistical aspects of the trials, and ensuring strong project management throughout study execution.