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AbstractIncreased transparency is one of the provisions of the Clinical Trial and Medical Device Regulations. This article discusses the impact of transparency and disclosure on medical devices. Many modern-day medical devices are software-driven.…
It is widely acknowledged that resolutions of difficulties tend to engender new problems. Increasingly, complex systems perpetuate increasing complexity. This discursive essay suggests that the most promising of discoveries, innovations, and…
Health literacy is defined as “the knowledge, motivation, and competence to access, understand, appraise and apply information to make decisions in terms of healthcare, disease prevention, and health promotion” according to Quaglio et al.5 Poor…
In 2015, the EMA Policy 0070 came intoeffect as part of EMA’s commitment toincreased data transparency. In short, clinicalreports included in regulatory applications forexample, marketing authorisations are pub -lished on the EMA web page and…
As the EMA refines its requirements for the external publishing of clinical study reports, the workload of medical writing teams is increasing to include robust processes for clinical study report anonymisation. Until now, life sciences firms have…
We describe the development of a graphical abstract for lay summaries of clinical trial results. The new graphical summary serves the same purpose for a lay summary as an abstract does for a scientific publication. Lay summaries are intended to…
The sharing of individual participant-level clinical data is now an almost routine extension of the clinical study life-cycle, and increasingly a vital element of leveraging real-word data. Responsible clinical study data sharing of appropriately…
Greeting from the croft! During my non-linear career path, there has been one recurring theme that always rang true: “Context matters”. As a physical therapist working in a rehabilitation centre, understanding my clients’ social roles, home…
Some of you might remember the old days when writing was done with a typewriter, spreadsheets were big pieces of paper, and slides were printed on film. Thanks to computers, these are old memories, and we can all be much more productive. Software…
Calling all medical writers:
Focus your writing with lean authoring
In today’s medical writing environment, authors are routinely faced with expedited timelines to write documents about highly complex studies with overwhelming amounts of data. Revi…
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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