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Our biostatisticians provide scientific approach to study planning and data analysis of clinical and non-interventional studies

Sample size
Study protocol
Statistical data analysis
Randomization schedule
Statistical analysis plan
Tables, Listings and Figures (TLFs)
Interim statistical report
Final statistical report
Study planning stage
  • Consider design options
  • Estimate sample size
  • Input to and development of statistical sections of the study protocol, including objectives, endpoints, estimands and statistical methods
  • Specify data collection requirements in line with the formulated objectives
  • Provide detailed statistical analysis plan and TLFs shells
Reporting stage

Our biostatistics and statistical programming services provide support for the implementation of complex statistical methodology for clinical development plans and/or individual study protocols for various types of studies, including those from small molecules (original and generics) and biologicals (original and biosimilars). We assist our clients in the elaboration of study design, including adaptive designs, sample size determination, statistical methodology for the study protocol, preparation of statistical analysis plan and statistical programming.

Why Our Clients Choose Us

During the active clinical phase, the biostatistics team of OCT Clinical provided significant support in verifying the methodology for collecting, maintaining, validating, and interpreting data for endpoint evaluation. The statistical analysis plan was created in accordance with industry standards and common data analysis approaches within the global clinical drug development program.

We are happy with the results OCT Clinical has been demonstrating for the project.

The OCT Clinical team met our goals under very difficult conditions. The achievement is quite impressive, considering the challenging circumstances imposed by the global pandemic.

Team Leaders

Kristina Bondareva
Head of Biostatistics at OCT Clinical

A Penn State University graduate with a Master’s degree in Applied Statistics, Kristina also holds an undergraduate degree in Computational Mathematics and Cybernetics. Kristina has wide-ranging experience working as a statistician in the field of clinical research and she knows exactly how to draw up a study design, undertake planning and carry out statistical analysis for both local and global clinical studies, as well as for non-interventional studies. Besides, she has an impressive portfolio of bioequivalence studies. She is, without a doubt, one of the key experts within the company, and leads a highly valuable department.

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