Project Management and Monitoring

To achieve smooth and effective project management, the company uses a ‘one-stop shop’ approach in which all communications with the Sponsor go through one appointed project manager.

Both project managers and clinical research monitors at OCT are certified doctors, pharmacologists and chemists. When monitoring, a risk-based approach is used, and if necessary, specialists resort to remote monitoring of the activities of the research site.

Risk assessment

Sponsors can fully rely on the company's experts to successfully conduct research to a high standard, in a timely manner and with effective risk management.

  • Our experience gained over 19 years in the industry means we can predict any potential risks and obstacles at the design development stage and circumvent them in advance.
  • A thorough feasibility analysis allows us to assess the possibility of conducting a particular clinical trial as realistically as possible.
  • Proper monitoring of research sites ensures reliable quality control.

OCT project managers provide prompt reports with forecasts of possible obstacles, analyze trends, and offer recommendations on how to eliminate identified risks. The sponsors themselves determine the level of their involvement in the project, while OCT assumes responsibility for the remaining tasks within the study.

One-Stop-Shop Approach

For effective communication with clients, the following strategy is applied: a project manager is assigned to each client, and they ensure prompt and effective resolution of any issues throughout the project.

OCT project managers have on average more than 5 years of experience in the industry, while most employees have worked in global CROs and world TOP-10 pharmaceutical companies.

Clinical Research Management System

All projects supervised by OCT are coordinated using the certified Clinical Trial Management System (BSI CTMS). Our customized version of the software is called STREAM. In addition to the extensive functionality aimed at strict compliance within specified deadlines, system options include the eTMF function, which allows Sponsors 24-hour access from anywhere in the world to control the workflow during research, which significantly increases the quality of the project.

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