Medical writing is the generation of clinical trial documents. The main goal of medical writing is to ensure the relevant information is presented accurately, and in a clear format that is easy to understand. For documents that are patient-facing, this means making sure a university education is not required for understanding. For documents being submitted to health authorities, this means making sure the study is clearly explained (in the protocol) and data is clearly presented (in the study report). AO Regulatory Consulting generates and copyedits the following documents:
- Protocol synopsis
- Clinical protocol – original and amendment
- Clinical study report (CSR) – abbreviated and full
- Patient narratives
- Investigator brochure (IB)
- Informed consent form (ICF)