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Retracted publications, the issue of poor results reporting, and the increasing value of online teaching methods. Fang et al.1 think that it is important to evaluate scientific publications that have been retracted because they feel studying…
In a post-pandemic world, master protocol studies will be an integral part of the “new normal” for clinical research and play an important role in providing actionable data to support health policy and resource allocation. Medical writers and study…
Laura C Collada Ali wears different hats: she is a medical writer plus a medical translator, and has extensive experience delivering multilingual authoring and translation services across a wide range of independent research organisations. She is a…
The clinical research landscape is gradually changing as we enter the era of big data. Big data sources are multiplying as existing sources collide to create expanded platforms that serve wider areas of expertise. Clinical study designs…
Although the medical device and pharmaceutical industries are related, they are governed by distinct regulatory systems. Despite the similarities, the inherent differences between medical devices and drugs have implications for clinical research…
The new EU Medical Device Regulation 2017/745 (MDR) requires companies to provide a periodic safety update report (PSUR) and a post market surveillance report (PMSR). Creating these reports will strengthen the post market surveillance and vigilance…
Whoever writes wants to be read. Yet, even if we succeed in creating an informative, logically structured, and adequately worded text tailored to our target audience, i.e., text we consider to have an adequate level of readability, our documents may…
Community pharmacy has been recently criticised for selling products which do not have a rational or robust evidence base. Available evidence suggests that pharmacists understand and are willing to embrace the concepts of evidence-based medicine…
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…
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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