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Clinical Study Design Preparation
MedSci Consulting and Excellence™
Consulting and Regulatory Support
Drug Safety and Pharmacovigilance
Project Management and Monitoring
Clinical Data Management
Biostatistics for Clinical Studies
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Project Management and Monitoring

For project management in clinical trials, OCT applies a single-window approach to the communication flow between sponsors and project managers, streamlining clinical trial operations and providing seamless CRO site management.

To ensure efficiency for project management in clinical trials, we implement a single-window approach with a streamlined communication between a project manager and our client. Both OCT project managers and clinical trial research associates (CRAs) are certified doctors, pharmacists, biologists or chemists. When monitoring, we apply a risk-based approach to perform CRO site management tasks, balancing between on-site and remote monitoring of the study site activities.

Our goal is to become your trusted partner. If you work with us, all issues are resolved instantly, only a phone call or an email away, within 24 hours.

Andrei Stefashin
Senior Project Manager

Risk-Management Approach

Sponsors can fully rely on OCT in terms of successful clinical trial conduct from “a” to “z” with a proactive management of timelines and risks. Our specialists are trained to foresee pitfalls and uncertainties:

-due to our vast experience of almost 15 years, we can anticipate many challenges at the study design development stage;

-we always perform a thorough feasibility analysis to ensure a realistic assessment of the possibility to conduct a clinical trial;

-close monitoring of sites allows for reliable quality control.

Our project managers prepare, in a timely manner, a prognosis of possible bottlenecks, analyze tendencies and give recommendations, as well as preparing options to overcome the hurdles. Sponsors determine their extent of involvement in the project and our team takes over all other tasks and responsibilities within the clinical study.

Single-Window Communication

We place high value on effective communication with our clients. To that end, we apply a single-window approach to the “sponsor-project manager” communication flow. Our clients have a single point of contact – a highly competent project manager who provides a timely response and proactive approach. Our project managers have an average experience of over 5 years in the industry, and many of them have worked for global CROs and Big Pharma.

Clinical trial management system

At OCT, we run our projects in BSI clinical trial management system (CTMS). STREAM is the name of the customized version of CTMS. In addition to a wide functionality aimed at strict compliance of the project with the deadlines, the system includes the eTMF function that allows sponsors to monitor their study online with a 24/7 access from anywhere in the world, which essentially brings the quality of a project’s workflow to a new level.

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