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We are living in an era of data deluge. With the amount of data generated increasing rapidly, organisations are in high need of individuals who are skilled at managing, analysing, and interpreting data. Data literacy is deemed as a crucial…
Analyses of integrated databases of efficacy and safety are a Food and Drug Administration (FDA) requirement. They are very useful in evaluating the safety and efficacy data gathered in multiple clinical studies. However, their utility is dependent…
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)…
Multivariable analyses are some of the central statistical methods of clinical trials, and yet some medical writers may be unsure as to what they are and how best to interpret and report the results. In this article we provide an overview of…
The present participle using and the past participle based on, both traditionally adjectivals, ostensibly misfunction without a noun to modify (a modifee). The frequency of their usage and misusage in research writing justifies a separate article…
Artificial Intelligence (AI) is a broad umbrella term that refers to the use of computer algorithms to perform tasks that typically require human-like intelligence, such as reasoning, learning, decision-making, and perception. The new EMWA AI…
Background: The European Union Clinical Trials Regulation 536/2014 (EU CTR) requires sponsors to submit summaries of clinical trial results in plain/lay language (Plain Language Trial Summaries [PLTS]). A multidisciplinary working group developed…
The freelance medical writing landscape has evolved in recent years, with more market demand for competent medical writers who can work on a project basis. In January 2023, the European Medical Writers Association’s (EMWA) Freelance Business Group…
Biostatisticians and medical writers are among the key people who develop important documents for clinical trials. These documents include clinical study protocols, statistical analysis plans, statistical outputs, and clinical study reports. This…
In the second part of the review on ‘English for Medical Purposes’, I present the main results of the research conducted on spoken interaction in medical settings. I start with those EMP studies that have a clear pedagogical goal, followed by EMP…
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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