Medical Writing In Clinical Research

Medical writing primarily involves the creation of scientific documents describing, for example, research findings, product usage, disease or drug-related educational and promotional literature, publication articles such as journal manuscripts and abstracts, content for healthcare websites, health-related magazines or news articles, and other medical information. A medical writer does not do research, but rather collaborates with doctors, scientists, and other subject matter specialists to convey information in an acceptable manner by generating documents that effectively and clearly describe the issue. In addition, the medical writer ensures that the documents adhere to regulatory, journal, or other criteria in terms of content, format, and structure. 
The demand for medical writing in the pharmaceutical industry is increasing as more new drugs and medical devices are developed and submitted to regulatory authorities during the approval process. A variety of scientific documents must be generated for submission to regulatory authorities during the approval process. Drug, device, and biologic approval processes involve extensive documentation, which regulatory bodies require for approval. Regulatory medical writing is a large part of this process. New pharmaceuticals must go through an increasingly complex process of clinical studies and regulatory procedures before they can be approved for use on the market. In response to this desire for clear articulation of medical science, there is a growing demand for well-written, standards-compliant documentation that regulators can easily and swiftly navigate through (e.g., in Common Technical Document [CTD] format), read, and comprehend. Because the pharmaceutical industry realized the need for specialized knowledge and expertise to generate well-structured documents that communicate information clearly and simply, the function of medical writing has become well established, particularly in the pharmaceutical industry.
A medical writer is regularly involved in the preparation of the following documents:
Research documents, e.g.:
•        Clinical trial protocols
•        Study reports
•        Investigators′ Brochure
•        Research proposals
Regulatory Documents, e.g.:
•        Characteristics of the Product in Brief
•        Patient Information Leaflets
•        Clinical study reports
•        Subject narratives
•        Regulatory submission documents
•        Safety reports
•        Disclosure of clinical results 
 

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