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In this article, I summarise how, as a medical writer with over 20 years of experience in regulatory writing, all with a contract research organisation, I transitioned into the world of disclosure and how I now have my feet firmly in both camps:…
Clear communication with the public and with potential clinical trial participants and their caregivers is foundational to the ethical tenets of respect, justice, and beneficence. However, health literacy, even of highly educated individuals, often…
Major clinical research funders are increasingly adopting policies supporting or mandating data sharing. These moves should improve the transparency and availability of clinical trial data and are likely to impact the work and responsibilities of…
Drug development forms the core of the pharmaceutical industry. Medical writing is a key function in pharmaceutical companies and clinical research organisations that works on scientific publications and regulatory dossiers. Regulatory writing…
In contrast to controlled clinical trials, findings of preclinical studies are not available. The road from laboratory discovery to usable therapy is still long and windy. Many preclinical studies have not been replicated by the pharmaceutical…
Laura C Collada Ali wears different hats: she is a medical writer plus a medical translator, and has extensive experience delivering multilingual authoring and translation services across a wide range of independent research organisations. She is a…
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…
I first met Brussels-based lawyer, An Vijverman, at the European Centre for Clinical Research Training Data Transparency Conference in February 2019. The conference brought together the clinical trials industry – sponsors and contract research…
Medical writing teams are crucial in the pharmaceutical industry at every stage of drug development. With growing regulatory pressure and shrinking profit margins, outsourcing these activities is considered a viable option that provides multiple…
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…
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