All documents are prepared by OCT’s own medical writers who are highly qualified specialists with scientific, medical background and expertise in biostatistics. The prepared documents are compliant with the corresponding ICH GCP principles and regulations of the authorities.

Our experience has shown that close cooperation within the clinical department allows for the development of effective strategies for sponsors of clinical trials. This is why OCT’s medical writers are in regular communication with the Regulatory Department as well as the biostatisticians.

We prepare medical documentation both as a separate, stand-alone service, as well as within the framework of a ‘full service’ project. Our highly qualified translators, translate documents to Russian and English. For any other languages the company outsources translators.


1

Investigator’s Brochure (IB)
The IB is a summary of the results of pre-clinical and clinical studies of a medicinal product.

2

Study Protocol
Successful experience in conducting pre-IND meetings, or meetings with the FDA (U.S. Food and Drug Administration), conducted prior to receiving approval for undertaking clinical trials

3

Case Report Form (CRF)
The CRF is a document used by the sponsor of a clinical trial to collect data about each patient participating in a clinical trial from each participating site. CRFs are prepared by OCT Data Managers together with 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.

4

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.

5

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

6

Clinical Study Report (CSR)
The Final Study Report is an overview of the data received in a clinical trial.

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.