OCT provides services within medical writing and review of the following Essential Study Documents:
All documents are written by specialists with a scientific, medical background and statistical expertise. Documents are compliant with the corresponding ICH GCP principles and regulations of the authorities. OCT Medical Writers work very closely with the OCT Regulatory Department and have vast experience in study design for different types of medical products, including biosimilars and biobetters.
OCT medical writers have been involved in more than 240 clinical studies, their medical documents have been successfully approved by the state authorities in the countries of OCT operations. Numerous Clinical Study Reports have been completed and successfully submitted to the authorities.
Medical writing can be a stand-alone service as well as being a component of the services provided as part of a clinical trial. OCT’s qualified and certified translators perform translations into Russian in accordance with the OCT SOP, outsourced translators are used for translations into other languages.