Ethics

In developing GCT our founders wanted to create a special research organization focusing on the needs of our clients and our employees above all else.

We have established a reputation for honesty and integrity by following a few basis rules:

1. Never over commit to a client
We never accept a project unless adequate resources are available to complete the project successfully. This simple rule of not over committing has allowed us successfully accomplish the projects even under the most stringent of timelines.

2. Empower our people
All of our Project Managers are experienced in effectively and efficiently managing clinical studies. Being given full responsibility for the success of the trial they have the authority to act internally as an advocate for the sponsor making available the full potential of GCT's resources. To help determine the needs of any trial the Project Manager will develop a project plan based on the parameters of the program supplied by the sponsor. This plan fully reflects the staffing and roles of each team member. We believe this structure makes our project teams focused and proactive in facing the changing circumstances often encountered during the conduct of a multinational clinical study. Issues we find critical to the successful management of a clinical project are:

The early identification of potential study issues and problems, so that clear contingency strategies can be in place to reduce or eliminate any negative impact;
An efficient communications plan that meets the sponsors needs;
A clear allocation of responsibilities between GCT and the sponsor;
A defined project plan identifying the tasks involved in the project and the timing of key milestones that mark overall progress.

By providing an experienced, flexible operations team, managed by strong Project Managers and management teams, GCT can successfully address any issue that may arise.

3. Provide interactive site management support
We provide high quality site management support with user-friendly tools that are responsive to the needs of the sites. Our Clinical Monitors are assigned to projects only after completion of intensive in-house and field training. We also provide comprehensive training on the specific protocol, indication, and compound prior to each study. GCT has also adopted a comprehensive training program that is implemented across all functions. In our work model our Monitors are responsible for each of their sites in terms of data quality, payments, start up, enrollment, SAE support, etc… and are empowered to act on their behalf.

4. Act as a strong “in country” advocate for our Sponsors
We act as an advocate for our sponsors in interactions with the Russian Health Authorities. As soon as the necessary regulatory documents are collected, a regulatory affairs manager is assigned who is responsible for approval from the Health Authorities. This manager will oversee the submission and track the approval process while carefully working with the Health Authorities to quickly answer questions and provide feedback to the study team.

Additional support is provided by an in-house group which provides administrative, quality control and quality assurance services to the monitoring team and project management staff. Our QC team is practiced at overseeing our work and ensuring that it meets the highest of standards. The quality of the work performed by GCT and its staff is monitored and audited throughout the life of the project. To support this role a QA auditor is assigned to the study as a fully independent team member reporting directly to the director general.

5. Remain employee focused and client friendly
We invest in a rigorous selection process to ensure that we hire with a standard of excellence. Then, we treat our people with respect, appreciation and caring. We ensure that they stay up to date in their therapeutic knowledge, monitoring practices and understanding of all applicable professional and legal guidelines of conducting clinical research through an investment in regular mentoring and training programs.

At GCT we have created a very positive, comfortable and friendly working atmosphere for our employees. By providing training opportunities, to include cross-training, we encourage employee growth and celebrate their value to our organization. Through empowerment our employees take ownership of the projects providing for greater job satisfaction and increased client awareness; ultimately leading to less turn-over.