Medical Writing

The medical writing team at OCT are highly-qualified experts who demonstrate a high level of competence and knowledge in various therapeutic areas and indications. Our specialists have in-depth expertise in biostatistics, which ensures that ICH GCP complies with the principles and regulatory requirements of Regulatory Authorities.

We prepare medical documentation both as a standalone activity and as part of our turnkey services. Our highly qualified specialists have been translating medical documents into Russian, English and other languages for many years.

Well-coordinated work within the clinical team allows us to develop effective strategies for Sponsors. That is why the OCT medical writers work in close cooperation with the regulatory department and the biostatistics team.

Our biostatistics specialists support the development of comprehensive statistical methodology, the implementation of adaptive design, the determination of sample size and biosimilar research methodology, and the development of a research plan and protocols, including the study design.

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