Medical Writing in Clinical Research

Medical Writing is the activity of producing scientific documentation by a specialized writer. It is that type of writing which requires huge amount of technical knowledge in relevant matter. The writer should have good knowledge of medical terminology as well as writing skills. A medical writer, working with doctors, scientists, and other subject matter experts, creates documents that effectively and clearly describe clinical research results, product use, and other medical information. The medical writer also makes sure the documents comply with regulatory, journal, or other guidelines in terms of content, format and structure. Medical writing as a function became established in the clinical research world because the pharmaceutical industry which recognized it requires special skill to produce well-structured documents that present information clearly and concisely. A growing number of new drugs go through the increasingly complex process of clinical trials and regulatory procedures that lead to market. This drives a demand for well written, standards-compliant documents that science professionals can read and understand easily and quickly.            

Medical writing in clinical research can be classified as either regulatory medical writing or educational medical writing. Regulatory medical writing means creating the documentation that regulatory agencies require in the approval process for drugs, devices and biologics. Regulatory documents can be huge and formulaic. They include clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures, and summary documents. Educational medical writing means writing documents about drugs, devices and biologics for general audiences, and for specific audiences such as health care professionals. There are several professional organizations represent medical writers around the world. Some of them are American Medical Writers Association (AMWA), European Medical Writers Association (EMWA) and Indian Medical Writers Association (IMWA). These organizations provide a forum where medical writers meet and share knowledge and experience. They promote professional development and standards of documentation excellence, and help writers find career opportunities. All these organizations offer fundamental medical writing training.