Corporate profile

Global Clinical Trials, LLC (GCT) is an International Regional CRO with its headquarters located in Princeton, New Jersey in the USA. GCT has worked to develop a strong reputation providing clinical research services across Eastern Europe and Russia. Operating from its regional offices in Russia (RCT), Bulgaria (BCT), Romania (RoCT), and the Ukraine (UCT) GCT is well positioned to support clinical research across the breadth of the Russian Federation, former Soviet Republics and Eastern Europe.

Since 2003 GCT has expanded its experience across numerous therapeutic areas working with international clients from across the globe. Whether you are looking for full clinical support to include site selection, monitoring, project management, regulatory, import/export, drug storage, and medical writing; or only interested in an individual service to address an urgent need, you can count on GCT to handle your requirements professionally and completely.

GCT was established initially by a group of research professionals focused on introducing regional patients to Western medicines that were out of reach for the majority of the local population. GCT understood the synergistic benefits of providing these patients access to both current and experimental medicines while recognizing the value in providing Western Pharmaceutical and Biotech Companies access to a large, eager, educated and compliant patient population.

To develop this global service capability GCT has concentrated on establishing processes to expedite the regulatory process, provide logistical oversight for international shipments, and establish SOPs that incorporate good clinical practices. The end result is a project management driven organization focused on the needs of our global clients and the regulatory authorities they each need to satisfy.

We offer a strong understanding of both local and international regulations as well as access to hundreds of qualified sites in numerous therapeutic areas. Our data base identifies over 2 800 sites throughout the region by indication and experience. Our pre-qualification process includes a review of ICH/GCP as well as local law to determine if additional site training is required; and if so GCT provides it.

Our monitors and project managers are all certified clinicians experienced in clinical research; many having previously been investigators themselves. As an organization, GCT maintains strong ongoing relationships with our investigators as well as the officials of the numerous regulatory bodies throughout the region. This helps GCT to develop reliable feasibilities and stay abreast of the changes in governmental regulations that may impact on clinical research. As your “In Country Advocate”, GCT will represent your organization with the kind of professionalism and attention to detail you would expect from your own team, except with the regional knowledge and local experience that can only come from years of working within the Region.

For details about GCT’s Global Capabilities please see the Global Coverage section.