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Global and multidisciplinary perspectives on collaboration with medical writers - Volume 33, Issue

Medical writers, document quality reviewers, and document specialists work together to produce high-quality clinical and regulatory documents. Cross-functional collaboration with other functional leads like bio statisticians, medical monitors, and…

Writing for orphan drugs: A compass to navigate document types and regional requirements - Volume 34, Issue

Medical writing for rare diseases encompasses the development of various regulatory documents that are required to obtain orphan drug designation and marketing authorisation for treatments targeting rare conditions. Effective planning and close…

Writing visually for medical writers - Volume 21, Issue

Although content is obviously important for effective documents, the look of a document is also important. If you want someone to read a document, it should be pleasant to look at, and if you want the document to be used, the information should be…

Unlocking new efficiencies: How structured content authoring is streamlining the production of clinical documents for the pharmaceutical industry - Volume 32, Issue

Current practice requires clinical and regulatory documents to be created and updated manually by medical writers throughout a product’s development. Conventionally, document content is unstructured, with freeform text, figures, and tables that the…

“Follow the Sun” writing: A hybrid operating model to optimize collaboration and efficiency - Volume 33, Issue

Time, quality, and accuracy are of the essence for expeditious global regulatory submissions. An around-the-clock, 24/7, global medical writing model has been developed that allows efficient development of high-quality documents with appreciable…

Optimizing the value of regulatory writers - Volume 31, Issue

An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly…

Translating “medicalese”: The case of informed consent forms - Volume 33, Issue

Informed consent forms (ICFs) are documents used in clinical research to inform prospective participants about – and obtain their consent for – partaking in a clinical trial. Evidence suggests that ICFs may not be fit for purpose because their…

A beginner´s guide to writing clinical investigation plans and reports for medical devices - Volume 31, Issue

A clinical investigation plan for a medical device must outline and justify all objectives of the clinical investigation, present and justify the investigational design and methodology, and state principal features of the statistical analysis. A…

The ABCs of paediatric plain language summaries - Volume 30, Issue

Plain language summaries need to be written at a proficiency level of 2 to 3, which roughly corresponds to a 6th grade to 8th grade reading level. Writing these for paediatric audiences brings even greater challenges. For communication to be…

Instructions for Authors

Instructions for Authors SCOPE Medical Writing, the official journal of EMWA (the European Medical Writers Association), is a quarterly journal that aims to educate, inform, and entertain medical writers. Medical Writing publishes themed issues…

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Scope

Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.

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