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Reviews provide a synthesis of published literature on a topic and describe its current state-of-art. Reviews in clinical research are thus useful when designing studies or developing practice guidelines. The two standard types of reviews are (a)…
The preparation of pharmacovigilance documents is related to ongoing activities during the life cycle of a medicinal product and encompasses crucial processes beyond writing: strategic planning and inter disciplinary work in the context of…
Dear EMWA MembersI was asked if the time between conferences is a quiet time. Having been in post just over 2 months at the time of preparing this report, I can most definitely state – NO! New initiatives are regularly proposed and I am often…
"From the Editor-in-Chief: Journal Watch is the re-birth of a previous column edited by Nancy Milligan. We are happy to welcome Hervé Maisonneuve, MD as the new Section Editor for Journal Watch. Hervé is a contributing editor for several scientific…
Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-Cas9 is a genome editing tool that helps scientists modify the DNA of living organisms selectively and precisely. The discovery of this system has led to changes in the approaches to…
This article explores the role of translation and translators within the process of test adaptation. With similarities to the linguistic validation process in clinical research, test adaptation is a complex multistep and iterative process in which…
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…
Language barriers in healthcare can put patients at risk, leading to misdiagnoses, delays in treatment, and exclusion from clinical trials. Clear communication requires cultural adaptation to ensure patients understand and trust the information they…
More than 30 years after the discovery of the human immunodeficiency virus as the agent that causes AIDS, an effective vaccine against this deadly disease has yet to be developed. The pathway to the development of a vaccine has been riddled with…
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…
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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