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Making the leap: Transparency requirements for clinical trials moving from one regulatory framework to another - Volume 33, Issue

This article discusses the fast-approaching deadline for sponsors to transition ongoing clinical trials in the EU/European Economic Area from the Clinical Trials Directive 2001/20/EC to the Clinical Trials Regulation 536/2014. In particular, the…

Preventing biomedical research waste - Volume 31, Issue

An estimated 85% of efforts in biomedical research are wasted due to inefficiencies. This wastage represents a global financial loss of greater than US$200 billion per year, a barrier to practicing evidence-based medicine, and a considerable amount…

Overcoming confidential information challenges faced by study sponsors today - Volume 32, Issue

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…

Essential principles towards improving clinical risk assessment tools: A conversation with Uri Kartoun, PhD - Volume 32, Issue

Uri Kartoun (PhD in robotics, Ben Gurion University of the Negev, Israel) is a Staff Research Scientist and an IBM Master Inventor, co-developer of technologies such as MELD-Plus, EMRBots, Memory-memory (M2) Authentication, and Subpopulation-based…

Regulatory Matters - Volume 32, Issue

Systems biology and real-world data as drivers of change in drug research and development In recent years, systems biology is not only being applied in fundamental science but also in drug development and healthcare. The application of real-world…

President’s Message - Volume 33, Issue

See you in Valencia… Time is flying. We just left the autumn conference and now are approaching our main EMWA event – the spring conference, to take place May 7– 11, 2024. This time we go to Valencia, and I am sure that no one needs to be…

The role of translators: Adaptation of mental health tests beyond clinical research - Volume 33, Issue

This article explores the role of translation and translators within the process of test adaptation. With similarities to the linguistic validation process in clinical research, test adaptation is a complex multistep and iterative process in which…

Biomanufacturing and One Health - Volume 32, Issue

At a time when the scope of One Health is expanding, the term “biomanufacturing” has taken on new significance as a new route to more sustainable manufacturing in the face of the current overwhelming reliance on fossil resources for fuel, energy,…

The need for community: The importance of networking as a freelance medical writer - Volume 32, Issue

Community and networking activity can really help when you are a freelancer. Who do you turn to when it all gets too much? Can someone, anyone, who understands your challenges, offer a sympathetic ear and help to work out a solution? Where do…

Speaking your patients’ language – Is it really worth it? The impact of translation on multilingual patient education materials - Volume 33, Issue

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…

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Scope

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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