Global Clinical trials (GCT) was established in 2001 by experts in the pharmaceutical industry, and KOLs in the CNS field – Jeffrey T. Apter, MD and Eugene Selivra, MD.
We have been a reliable partner for biotech, pharmaceutical and medical device companies, including the top 10 companies in the industry worldwide. Headquartered in Princeton, NJ, USA, GCT operates through 12 offices offering top-notch clinical services in the USA, Europe, and Asia. See our coverage.
Our mission to date is to provide a tailored approach for every project, whether managing the entire study or assisting with a standalone service as a functional service provider. Check our services.
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 our potential both to local and international Sponsors and thus offer our unparalleled expertise in cooperating with the national regulatory authorities globally, tackling logistical aspects, and ensuring strong project management throughout study execution.
Reasons why companies choose to outsource their projects to GCT:
Our professional staff have been sharing their unique experience and utilizing established contacts with the key opinion leaders (KOLs) and top recruiting sites. GCT project managers with many different backgrounds and specialties each have a minimum of 5 years Industry experience supporting and managing clinical programs. Our CRAs all have on average 3 years of industry experience.
Quality Management System based on the internally developed Standard Operational Procedures (SOP) and have successfully passed more than 90 regulatory inspections and external audits, including the ones by the U.S. Food and Drug Administration (FDA) and regulatory inspections in Russia and Ukraine by local authorities (Ministry of Health).
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 have 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.
We are working to proactively assess each study’s needs in any situation to keep to your project timelines and goals.