Legislation and the lay audience: Challenges of communicating benefit and risk in the light of new regulations - Volume 24, Issue

There is a paradigm shift in the pharmaceutical industry and regulatory agencies towards transparency and an emphasis on the benefit-risk ratio of medicines. The recent changes in legislation surrounding clinical documentation have produced…

Communicating With the Public - Volume 34, Issue

Nonclinical studies in the Russian Federation — Problems, regulatory norms, and harmonisation with international standards - Volume 26, Issue

Drug product developers and sponsors face a number of problems when organising a nonclinical study in Russia, especially, the diverse range of standards and few certified animal breeding centres, complicating adaptation of the available experimental…

The clinical study protocol and medical writing: A good fit? - Volume 23, Issue

The characteristics of the clinical study protocol (CSP) are discussed with regard to (i) its structure and (ii) its development process. The benefits of medical-writing involvement into both aspects are highlighted. In particular, medical writers…

An overview of the Common Technical Document (CTD) regulatory dossier - Volume 23, Issue

The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documentation included in an application for the registration of a human pharmaceutical product. The CTD dossier is divided…

Successful document collaboration in a virtual team - Volume 22, Issue

When several contributors are working on the same document, challenges are often created for both managers and contributors. This article discusses how technology can be used to help produce documents in collaboration.

Communicating the findings of health technology assessments: Considering uncertainty - Volume 30, Issue

Uncertainty is an unavoidable problem when analysing health technology assessment results, which can make decision making difficult. Whilst we have ways of presenting uncertainty for individual outcomes in a systematic review, we do not have a…

Health economists and medical writers: Collaboration or collision? - Volume 22, Issue

Medical writers are perceived by many health economists to be incompetent in health economics writing. Medical writers need to abolish this common perception, and so must develop an understanding of cost-effectiveness, cost-utility, and other health…

Finding the action in your writing: Avoiding nominalisation - Volume 26, Issue

Dense, hard-to-follow writing obfuscates complex subject matter, but writers can improve their ability to communicate complex topics with clear writing that is easily understood on a first read. Science and medical  writing often contain grammatical…

Clinical trial disclosure: Perspective from a medical writer for a contract research organisation - Volume 28, Issue

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:…