Global Clinical Trials (GCT) - Drug Technology and Development

Global Clinical Trials (GCT) is a full service contract research organization (CRO), with a provincial focus and global perspective. Established in 2001 in St Petersburg, Russia, GCT has grown into a strong and experienced regional CRO focused in Eastern Europe.

In 2003 GCT’s corporate headquarters were moved to Princeton, NJ, USA to better serve the needs of clients. In addition, there are five full service offices in Russia, the Ukraine, Bulgaria, and Romania, delivering experienced clinical, regulatory and logistical support to clients from all over the world.

Managed by a team of clinical research professionals with over 50 years of combined industry experience, GCT maximizes the benefits of the region with a complete understanding of international research standards, and the specific challenges that these types of trials present.

CLINICAL MANAGEMENT

Global Clinical Trials maintain a staff of project managers who are all medical doctors with various different backgrounds and specialities. Experienced in clinical research and patient care services, GCT project managers each have a minimum of five years industry experience supporting and managing clinical programmes.

In addition to the medically trained programme managers, our CRA's also have secondary medical degree’s, and on average have three years of industry experience. GCT invests in on-going staff training in good clinical practice, general monitoring and project management activities.

Our team of dedicated professionals continue to develop strong relationships with each site, based on mutual respect and a scientific understanding among peers.

GCT takes employee training to another level. In addition to the standard training curriculum on GCP and project training, GCT also offer cross-training opportunities; allowing our employees to develop a stronger understanding of the clinical research process, and see first-hand how their current position and the work they perform may affect other areas of service.

CLINICAL TRIAL REGULATORY SUPPORT

Global Clinical Trials provide complete regulatory services for each country where we have an office or an affiliate is situated covering Eastern Europe and the former Soviet States.

Each trial is assigned a regulatory associate to work with the clinical team and maintain daily communications with the numerous regulatory bodies.

Everything from protocol, submission and approval, to processing of amendments, generating annual reports, and responding to specific regulatory queries and requests, are handled effectively by our experienced and supportive regulatory team members.

We work hard to keep the regulatory process moving, often completing submission deadlines ahead of projection.

MARKET APPROVAL

With the knowledge and experience of our dedicated regulatory unit, GCT can now support your post-marketing regulatory needs. In addition to regulatory services associated with clinical research, GCT offers full regulatory support for drug and medical device registration in Russia.

Once you've proven your product is safe and effective, let GCT help you provide access to the growing Russian market.

DRUG STORAGE AND DISPENSARY DEVELOPMENT

To expordite importation and exportation of clinical materials, Global Clinical Trials has developed a separate logistics group to support importation and exportation of study materials for drug development.

Within Russia, GCT owns and operates its own storage facility and drug dispensary. Ownership of this facility helps GCT to maintain costs, while providing quality services in line with good clinical practice guidelines.

In other countries, GCT has on-going contracts with third-party storage facilities that have made commitments to quality, local and international storage and shipping requirements.

GCT will handle all importation and exportation requirements for your trial from the beginning to the end. For those instances where our clients need to ship study materials, GCT will carefully and completely walk you through the labelling and shipping procedures required for each country we support. Let our local experience be your international strength.

CLIENT FOCUS

Global Clinical Trials is a customer-focused service organization that emphasizes communications and pre-study planning to ensure trial success and client satisfaction.

The bulk of the projects that GCT have been awarded has come from repeat clients. More than 80% of clients that have used GCT have come back with additional work. Our flat management structure provides easy access for our clients to interact with our senior management.

Our experienced and medically trained project managers are empowered to supervise their project while maintaining constant communications with our clients.

Our clinical research associates are all medically trained and educated to doctorate level, with the ability to predict potential hurdles, and recommend the necessary adjustments to keep the project moving forward successfully.

REGIONAL FOCUS WITH GLOBAL PERSPECTIVE

Global Clinical Trials is an experienced regional full service clinical research organization with a track record of success. Let GCT introduce you to this exciting and successful region, and let us demonstrate why, with GCT, this is the best area in the world for quality clinical research.