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The new value of clinical data in Europe - Volume 29, Issue

The EU’s new Medical Devices Regulation and In-vitro Diagnostic Device Regulation has integrated and reinforced the regulatory requirements for pre- and post-market clinical trials and positioned them as vital to ensuring the safety and performance…

CORE Reference – a tool for modern clinical study reports in an era of increasing transparency and disclosure - Volume 27, Issue

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…

In the Bookstores - Volume 31, Issue

As the authors of this book, Koen Cobbaert and Gert Bos, state “software joins the dots, by connecting patients with healthcare professionals and breaking down the boundaries between everyday objects, medical devices, and medicine.” As a medical…

Bringing decentralised clinical trial protocols to life - Volume 32, Issue

Decentralised clinical trials (DCT) use technology, processes, and services to reduce or eliminate the need for onsite visits. Use of DCT components within clinical trials is becoming widespread and protocols are pivoting from using DCT components…

Regulatory Public Disclosure - Volume 29, Issue

Activities around clinical documents disclosure have been slow since September 2018 when I last published this section. As many of you receive emails from the CORE Reference website (sign up at https://www.core-reference.org/subscribe), you have…

Profile: An interview with Ingrid Edsman on why attending EMWA conferences is so rewarding! - Volume 24, Issue

Ingrid Edsman, with 17 years of increasingly senior clinical research positions in the Pharmaceutical Industry, is an expert in the preparation of regulatory and clinical documents. She obtained a Medical Degree at the Karolinska Institute in…

Profile: An interview with Esther Moreno Barriuso: On some fundamental concerns of medical interpreting - Volume 23, Issue

Interpreting has had a fundamental role in the history of medical knowledge – it calls directly on such concepts as cultural displacement, originality, and orality.

Profile: An interview with Blanca Mayor Serrano on the state-of-the-art of health literacy in Spain - Volume 22, Issue

There seems to be a move towards ‘patient-centred’ health care as part of an overall effort to improve the quality of health care and to reduce costs. Individual patients and providers have to work together to ensure effective communication.…

An interview with Cathal Gallagher of EMA’s Technical Anonymisation Group - Volume 29, Issue

In our daily work in a company or freelance setting, we interact with other relevant functions, typically biostatistical, medical, programming, and data management colleagues, so that we can deliver wellrounded deliverables that take account of…

Profile: An interview with Fernando Navarro on the brand new platform ‘Cosnautas’ - Volume 23, Issue

Some people may still not be aware of the big news last summer in the Spanish medical translation and writing world: Fernando Navarro's Libro Rojo (translated as ‘Red Book’, one of the most authoritative English to Spanish dictionaries of medicine)…

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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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