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From scurvy to Covid-19: The role of clinical trials, and medical writing’s crucial role in the process The medical writing community is intrinsically involved in regulatory documentation that spans the entire timeline of clinical research – from…
The 55th EMWA Conference took place on May 9–13, 2023, in Prague. With more than 400 participants from across Europe and the world, it was a rousing success. Topics of workshops and presentations ranged from the latest in regulatory writing and…
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…
As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which cont…
This article presents an overview of open access initiatives by researchers, journals, government bodies, and regulatory authorities. Open access initiatives are valuable to the scientific community and have increased the amount of clinical research…
Knowing that the main theme of this issue of Medical Writing is writing for the lay audience, I was thinking hard about what would be the most relevant topic to discuss in the Lingua Franca and Beyond section. My thoughts went to a topic that…
Navigating the new era of clinical trial transparency This issue of Medical Writing comes at a time when the summer holidays are behind us. Here’s hoping it has been a relaxing and rejuvenating time for all. As we get back to our day-to-day work,…
Adoption of the EU Medical Devices Regulations and In Vitro Diagnostics Regulations has led to increased demand for systematic literature reviews. This article reports on a survey investigating the current use of software platforms and tools by…
This article focuses on the medical device specific aspects of clinical investigations and does not aim to be a comprehensive introduction to clinical trials. We highlight the key differences to clinical studies of medicinal products in the…
This article discusses the role of translation and its impact on the success of patient education materials, particularly in the context of patient recruitment and retention for clinical trials. We examine how translation and localisation help…
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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