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Clinical versus Regulatory Medical Writing

Clinical and regulatory medical writing are two distinct areas of medical writing with different objectives and audiences. At Cipher HCC we provide both.




Clinical medical writing involves writing documents that are intended for healthcare professionals, such as clinical study reports, protocols, manuscripts, and clinical summaries. These documents provide detailed descriptions of clinical trials, including study design, data analysis, and the results of the study. The purpose of clinical medical writing is to provide an accurate and detailed account of the clinical trial, which is used to support regulatory submissions and to communicate the results to the scientific community.


On the other hand, regulatory medical writing involves writing documents that are intended for regulatory authorities, such as the FDA and EMA, as part of the drug development process. These documents include regulatory submissions, such as the Investigational New Drug (IND) application, New Drug Application (NDA), and Marketing Authorization Application (MAA). The purpose of regulatory medical writing is to provide a comprehensive and compelling case for the safety, efficacy, and quality of a drug or medical device.


While both clinical and regulatory medical writing require a deep understanding of scientific concepts, clinical medical writing is focused on communicating scientific findings to a scientific audience, while regulatory medical writing is focused on providing a comprehensive and persuasive argument for the regulatory approval of a drug or medical device.

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