Regulatory writing - Volume 21, Issue

The EMA, the FDA, and Health Canada head to head A recent issue of the New England Journal of Medicine carried an article comparing the regulatory review times of novel therapeutics by three different regulatory agencies (FDA, EMA, and Health…

Transparency through the lens of data protection and privacy: A clinical research organisation medical writing perspective - Volume 33, Issue

Medical writers maintain a fine balance between data transparency obligations and personal data protection in clinical reports. Hence, we must stay informed of data protection requirements outlined in the EU General Data Protection Regulation (GDPR)…

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…

Working with authors to develop high-quality, ethical clinical manuscripts: Guidance for the professional medical writer - Volume 23, Issue

One measure of career success for clinical researchers is reporting their findings in a peer-reviewed journal. Writing a clinical manuscript that has impact and relevance to their intended audience is crucial for publication success. However,…

The Light Stuff - Volume 22, Issue

A call to abandon the useless anachronism of the ‘define at first use’ rule for abbreviations Definitions CTD – Common Technical Document (dossier submitted for marketing authorization) eCTD – Electronic Common Technical Document QC – Quality…

Global perspectives on EDIB: Advancing equity, diversity, inclusion, and Belonging in medical communications - Volume 33, Issue

The integration of Equity, Diversity, Inclusion, and Belonging (EDIB) principles within the field of medical communications is of paramount importance. EDIB principles, aligned with global guidelines on sustainability – encompassing labour…

Do you have what it takes to be a mentor or be mentored? - Volume 30, Issue

A skilled mentor can positively impact a mentee’s personal and professional development. A successful mentor-mentee relationship is contingent on mentor and mentee attributes, trust, and respect, and fit based on shared values and working style. To…

ICMJE requirements for sharing individual participant data from interventional clinical trials - Volume 28, Issue

Sharing of deidentified/anonymised individual participant data is rapidly becoming the norm. The International Committee of Medical Journal Editors recently implemented requirements for data sharing as a condition for considering publication of…

Medical Communications and Writing for Patients - Volume 30, Issue

Dear All,

As I write this, at least some of us are likely to still be in some form of lockdown or quarantine. I pray that you and your families are all managing to stay as sane as possible, and I sincerely hope that you all stay safe and healthy.

I…

English Grammar and Style - Points of view - Volume 23, Issue

Anu Alahari, a freelancer working in Caen, France, asks: ‘Could you please take a few minutes of your time to give your opinion on a simple language issue. Which of the following phrases is grammatically most correct? And which one would you use in…