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Biostatistics

Our biostatistics services provide a scientific approach to study planning and data analysis for clinical trial outsourcing

Our experience has shown that close cooperation between our departments allows for the development of effective clinical research strategy for our sponsors. Therefore, OCT’s medical writing team works on study protocols in close collaboration with biostatisticians as well as the regulatory and clinical departments. Our biostatistics services provide support for complex statistical methodology and implementation of adaptive designs, clinical development plans and/or individual study protocols, including study design, sample size determination, biosimilar study designs and methodology, regulatory guidance for representation at meetings with global regulatory authorities.

The main task of a biostatistician is to ensure that a trial is able to provide valid results. Statistical thinking should be applied as early as possible, at the stage of designing a clinical trial or even earlier, when sizing up the feasibility of a certain clinical trial.

Kristina Bondareva
Head of Biostatistics

Our biostatistics services deliver a scientific approach to study planning and data analysis:

The European Medicines Agency (EMA) adopted the E9(R1) addendum on estimands and sensitivity analysis in clinical trials effective July 30 2020. Bringing clarity to the concept of estimands and the key issues debated in E9(R1) will help to understand their purpose and impact on study design, statistical analyses and the study outcome. Discover how the new framework will improve the way of designing and planning clinical trials and performing primary analyses and sensitivity analyses. Watch a webinar hosted by our Head of Biostatistics Kristina Bondareva.

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