MEDICAL WRITING
Medical writing applies the principles of clinical research and scientific writing in developing clinical trial documents that effectively and clearly describe research objectives, methodology, statistics, results, product use, and other medical information. Medical writing is also about the development of any of the five modules of the Common Technical Document, systematic reviews, and aggregate reports applicable to the field of clinical research and pharmacovigilance. We ensure that their documents are written in an academic manner and comply with the regulatory, journal, or other applicable guidelines in terms of content, format, and structure.
Medical Writing Activities
- Planning and execution of general medical writing activities/projects for the assigned therapeutic area.
- Researching, writing, and editing clinical research documents including but not limited to investigator’s brochures, study protocols, informed consent forms, clinical study reports, scientific publications, CTD dossier modules, clinical overviews and summaries, safety and efficacy aggregate reports, etc.
- Researching, preparing, writing, and editing creditable systematic literature reviews.
- Synthesizing and analyzing the clinical data from medical and scientific publications on a range of medicinal products and medical devices.
- Participating in core process steps for clinical research documents’ development and systematic literature reviews including search, screen, data extraction, analysis, and synthesis of the literature and applicable materials.
- Organizing clinical data from literature and applicable materials into references, graphics, tables, and data listings.
- Summarizing and interpreting results, including statistical parts, from the medical and scientific literature and clinical research materials and presenting them in a clear, concise, and scientifically sound and accurate manner.
- Reviewing statistical analysis plans from the perspective of accurate and appropriate presentation of statistical data.
- Organizing all activities in strict compliance with FDA/EMA or other regulations and guidelines and following their specific content/format/style requirements.
- Demonstrating an understanding of assigned therapeutic areas, providing expertise and interpreting clinical research methodology and study design, ensuring compliance with global regulations.