All documents are prepared by OCT in-house medical writers and are compliant with the corresponding ICH GCP principles and regulatory requirements.
We are extremely proud of our team of inhouse medical writers. These top-notch experts demonstrate vast expertise on a variety of therapeutic areas and related subjects.
Our writers design Investigator’s Brochures (IB), Study Protocols, Case Report Forms, Informed Consent Forms, preclinical reports, clinical study reports.
Scientific approach, deep expertise on the regulatory specifics, high quality documents - that is what constitutes the contribution of our Medical Writing team to the success of every project.
Medical writing can be rendered as a stand-alone service as well as a component of the services provided within a turn-key clinical trial project. OCT qualified and certified clinical research translators work with study documents in Russian and English in accordance with OCT SOPs. For clinical translations into other languages, we use certified vendors.
Our experience has shown that close cooperation between OCT departments allows for the development of effective clinical research strategy for the sponsors of clinical trials. Therefore, OCT medical writers work 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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