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This is the first Medical Writing Biotechnology regular section. Biotechnology is a broad subject. It can be defined by the use of biological systems and living organisms in production processes. Biotechnology has been around for thousands of years.…
Altmetrics and other article-level metrics offer new opportunities to understand the impact of medical publications and, indeed, clinical trial programmes. For example, we can learn whether the publication has been viewed, shared, engaged with, or…
The EU Regulation 536/2014 included a requirement for companies to produce a Protocol Synopsis with a recommendation for a version in lay language. This requirement stated, among other things, a maximum length of two pages. This article outlines the…
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…
In with the new! When I joined EMWA in 2010, I never imagined that 13 years later I would attend the the 55th EMWA Conference as President and be part of the Executive Committee, a body which for a few years I had watched timidly and … with…
Automation and artificial intelligence (AI) are useful tools that are rapidly progressing in many fields within the clinical trial landscape, and their use in the production of narratives for clinical study reports is no exception. Technology and…
Clinical trials are becoming more complex and the efforts to optimise drug development are rapidly evolving. This Q&A gives a short overview of the strategies Bristol Myers Squibb implements to incorporate diversity into the clinical trial…
Anuradha Alahari (section editor) EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo OPEN framework extended to a wider range of medicines Global regulators agree on way forward to adapt COVID-19 vaccines to…
This article discusses the challenges and quality assurance measures implemented by the authors when translating medical reports. In particular, the authors discuss the challenges posed by acronyms, handwritten and scanned text, and desktop…
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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