Clinical Study Design Preparation
Medical Writing
Consulting and Regulatory Support
Drug Safety and Pharmacovigilance
Project Management and Monitoring
Clinical Data Management
Marketing Authorization
GMP Inspection Support
Clinical Supply Services and Logistics
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Scientific approach to study planning and data analysis

Our team of biostatisticians collaborates with medical writers and scientific experts in order to secure positive clinical trial results at the stage of study planning. Along with sample size calculation and study protocol preparation, OCT biostatistics experts provide support in complex statistical methodology and clinical development strategy. In addition to that, biostaticians provide regulatory guidance for representation at meetings with global regulatory authorities.

Given that Data Management and Biostatistics are the most vital part of conducting clinical trials, we place high importance on selecting the most advanced solutions and innovative approach to improve efficiency, reduce development costs and anticipate risks.

Kristina Bondareva
Head of Biostatistics

Our team delivers a scientific approach to study planning and data analysis:
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