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Update from the European Medicines Agency on development of its policy on publication and access to clinical-trial data From the European Medicines Agency, 13 November 2013 – The European Medicines Agency is currently reviewing and analysing…
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…
In its commitment to transparency, the EMA implemented Policy/0043 and Policy/0070 to make data accessible to all; however, this has given rise to the need for anonymisation of personal data in clinical reports. The analysis of the 64 submission…
Medical writing tends to contain longer, less common, words than English fiction, and they are here termed troublesome words. Troublesome words are an indicator of poor style, and often point to grammatical errors. An easy way to start improving…
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)…
As a medical writer, can or should I be listed as an author of an article? For manuscripts, medical writers often go far beyond providing basic services and therefore may feel entitled to authorship. Medical writers are often the main force behind…
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…
The most effective way of communicating new research findings is by publishing them in a peer-reviewed journal which is widely read and highly respected. To ensure that important new data are shared with the appropriate audience in a timely manner,…
Data sharing is encouraged by institutions and journals: Authorship of “shared” papers should be clearWhen researchers share data, the teams analysing them want to publish their results. How should authorship of publications be defined? Who are the…
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…
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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