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…

Quality control: getting the best out of your review - Volume 21, Issue

In medical writing, quality control (QC) means ensuring that a document's content, style, and format are of high quality. This does not just ‘happen’ but is the result of a systemic QC review. These reviews are critical because mistakes can cause…

How remote working can affect mental health: Work-life balance and meeting fatigue - Volume 31, Issue

When it comes to remote working, we often think about the many benefits this approach brings, such as being more flexible and productive, or improving our work-life balance. However, remote working without the right framework to profit from all…

Regulatory Matters - Volume 30, Issue

Calling all medical writers:

Focus your writing with lean authoring

In today’s medical writing environment, authors are routinely faced with expedited timelines to write documents about highly complex studies with overwhelming amounts of data. Revi…

#EMWATogetherApart - Volume 30, Issue

Dear colleagues, friends, and EMWA community, We hope you all had an exciting and educational 52nd EMWA conference. On behalf of the EMWA Executive Committee, I had great pleasure in welcoming you to the first Hybrid Opening Conference Day on…

AI/Automation - Volume 34, Issue

Section Editor: Daniela Kamir Exploring Research Rabbit: Your new favourite reference manager Author: Natasha Fallico   Medical Writing. 2025;34(1):67–69. https://doi.org/10.56012/wxzm3433

Mentor vs. line manager: Differences and similarities - Volume 30, Issue

A good mentor may be a good line manager in a business setting and vice versa, but there are some key differences: mentors are more skill-oriented, while line managers are more goal-oriented. People who are both good line managers and mentors are…

Trends in regulatory writing: A brief overview for aspiring medical writers - Volume 28, Issue

The EU regulatory system is undergoing a major overhaul. Several new pieces of legislation are now in place to enforce harmonisation and transparency in clinical trials while ensuring data security and individual privacy. New and aspiring medical…

An interview with Julia Cooper: Insights and experiences from leading a global medical writing team - Volume 33, Issue

Julia Cooper, PhD, is the Corporate Vice President and Head of Medical Writing Services at Parexel. In this interview, she shares her insights on the different aspects of leading a global medical writing team and on how she and her team at Parexel…

Population diversity in clinical trials for rare diseases: A regulatory writer’s perspective - Volume 34, Issue

Ensuring population diversity in clinical trials is essential yet challenging and increasingly complex in the rare disease landscape. The unique challenges in clinical development for rare diseases include limited medical and scientific knowledge,…