Clinical Study Design Preparation
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Clinical Study Design Preparation

At OCT, clinical study planning includes a thorough feasibility analysis, efficient patient enrollment and ongoing CRO site management.

We approach every project with a clear understanding that careful planning and detailed foresight is crucial for a successful study. With that in mind, it is critical to optimize clinical trial design in order to deliver according to the plan. Due to our vast experience of over 15 years, we can anticipate most of the risks and pitfalls at the study design development stage. Our clinical trial methodology is built with a strong focus on reaching the positive outcome of a study.

We never settle for a compromise when choosing between quality, timeline and budget. We always deliver the best on all three. This approach is built on the accumulated experience of the team of professionals and procedures polished throughout the years.

Irina Petrova, MD
Director of Clinical Operations

Feasibility

At OCT, study planning always starts with a thorough feasibility analysis to ensure a realistic assessment of the possibility to conduct a clinical trial. Our feasibility evaluation includes such steps as thorough protocol and inclusion/exclusion criteria review, feasibility questionnaire preparation, patient population assessment, development of successful patient recruitment techniques, analysis of investigator and site experience, and checking the availability of equipment and facilities required for a successful conduct of the study.

Patient Enrollment

We approach patient enrollment profoundly and with precision. Our goal is to recruit eligible patients within the stated timeline and budget, and develop a plan to implement patient engagement solutions throughout the full duration of the study.

CRO Site Management

Efficient monitoring of sites allows for reliable quality control. During on-site monitoring visits, OCT CRAs perform the following tasks to monitor compliance with GCP and local regulations:

Moreover, we are very thorough about sites selection in order to avoid involvement of underperforming units into the study.

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