Medical Writing

OCT provides services within medical writing and review of the following Essential Study Documents:

  • Investigator’s Brochure (IB).

    The IB is a summary of the results of pre-clinical and clinical studies of a medicinal product.
  • Study Protocol.

    Document determining the objectives, form, and methodology of a clinical trial, statistical methods of processing the results of such trial and safety measures for the individuals involved in the clinical trial of a medicinal product.
  • Case Report Form (CRF).

    The CRF is a document used by the sponsor of a clinical trial to collect data on each patient participating in a clinical trial from each participating site. CRFs are prepared by OCT Data Managers and reviewed by our Medical Writers.
  • OCT in-house fully validated 21 CFR part 11 compliant Clinical Data Management System MARTIX EDC supports both paper and e-CRF trials.
  • Informed Consent Form (ICF)

    The ICF is a document signed by study participants and describes the rights of the study participants, and includes details about the study: study purpose, duration, study procedures, key contacts, risks and potential benefits of the study.
  • Clinical Study Report (CSR)

    The Final Study Report is an overview of the data received in a clinical trial.
  • Pre-clinical Report

    An overview of the data received in a pre-clinical study.

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.