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Abstract Clinical evaluation is a structured ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device. The clinical data include current knowledge of the condition to be treated, published literature about the…
The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical…
Managing a complex publication plan for several products or indications with overlapping timelines can be challenging. Publication management software solutions are available to support the medical writer in planning, writing, approving, and…
CORE Reference (www.core-reference.org) facilitates the authoring of a content-driven clinical study report (CSR) that is as “public disclosure-ready” as possible. It has potential to increase the quality of final CSRs and enhance consistency within…
Protocol development is a critical milestone in the clinical drug development process for all pharmaceutical companies conducting clinical trials. A regulatory medical writer (RMW) plays a crucial role in the protocol development and peer review…
As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which cont…
True journalism differs from public relations and uncritically reproducing press releases. It involves doing background research into the context surrounding the finding being reported, seeking comments from independent experts, and highlighting the…
Medical writers are increasingly involved in designing and documenting overall plans in paediatric drug development, e.g. EU PIPs (Paediatric Investigation Plans) and individual components, e.g. protocols and study reports. It is essential to…
Anecdotes and quotes related (more or less) to scientific writing Pigeons are like editors, they both do the icky to your most cherished work, but at least pigeons don't say, Now it really sings. Cecil Adams, The Straight Dope Ignorant people…
Dear all, However experienced you are, and whatever ‘level’ medical writer you may be, we all share the same pain… document review processes. Every medical writer has at least one horror story related to review cycles going awry, and the mere…
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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