OCT Medical Writing services include:
- Preparation of Investigator’s Brochure (IB)
Investigator's Brochure (IB) is a summary of the results of preclinical and clinical studies of medicine product. - Preparation of Study Protocol
Protocol of a clinical trial of a medicinal product is a 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 the medicinal product. - Preparation of Case Report Form (CRF)
Case report form (CRF) is a document used by the sponsor of the clinical trial to collect data on each patient participating in a clinical trial from each participating site. - Preparation of Informed Consent Form (ICF)
Informed Consent Form (ICF) is a document signed by study participants and describing 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. - Preparation of Final Report
Final Study Report is an overview of the data received in a clinical trial. - Preparation of Pre-clinical Report
Pre-clinical Report is an overview of the data received in a pre-clinical study.
All documents are written by specialists with scientific background. Documents meet ICH GCP standards. OCT Medical Writers work very closely with OCT Regulatory Department. OCT Medical Writers have very good experience in study design preparations for biosimilar and biobetter medical products. Documents can be written as a part of clinical program conducted by OCT or as a standalone service.
