Clinical Study Design Preparation
Consulting and Regulatory Support
Medical Writing
Drug Safety and Pharmacovigilance
Project Management and Monitoring
Data Management and Biostatistics
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Medical Writing

All clinical trial documents are prepared by OCT’s in-house medical writers and adhere to all regulatory requirements.

We are extremely proud of our team of in-house medical writers. These top-notch experts demonstrate vast expertise in a variety of therapeutic areas and indications. In addition to the deep knowledge of clinical and medical questions, OCT medical writers are competent in biostatistics and can guarantee compliance with both local and international regulatory requirements.

Documents designed by our medical writers are Study Protocols, Investigator Brochures, Informed Consent Forms, preclinical reports, clinical study reports, scientific articles. OCT Medical Writers also perform GAP analysis of clinical and preclinical data.

Scientific approach, deep expertise in the regulatory specifics, high quality documents — that is what constitutes the contribution of our Medical Writing team to the success of every project.

Eugenia Radkova
Medical Writer

We offer medical writing as a standalone service as well as a component of the clinical trial services provided within a turn-key project. OCT’s qualified and certified clinical research translators work with study documents in Russian and English in accordance with our SOPs. For clinical translations into other languages, we use certified vendors.


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 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.

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