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 almost 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.
Director of clinical operations
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, checking the availability of equipment and facilities required for a successful conduct of the study.
We approach patient enrollment fundamentally and with precision. Our goal is to recruit eligible patients within the stated timeline and budget.
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:
·Training site personnel as required 100% review of all signed ICFs
·Review and verification of all available source documentation (100% SDV)
·Review of all clinical data at site for legibility, completeness and consistency with the protocol
Moreover, we are very thorough about sites selection in order to avoid involvement of underperforming units into the study.
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