Publication management software for medical writers - Volume 29, Issue

Managing a complex publication plan for several products or indications with overlapping timelines can be challenging. Publication management software solutions are available to support the medical writer in planning, writing, approving, and…

A wonderful "Medium" for medical writers - Volume 30, Issue

With the advent of social media platforms and the increasing availability and access of information on the internet, we are not limited by information sources on any subject. Medium.com, since its inception in 2012, has become a very good blogging…

Medical Devices - Volume 32, Issue

Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…

Improving patient communication by writing with empathy - Volume 21, Issue

Medical writers’ texts are either written for specialists or for non-professionals such as patients and their relatives. Medical writers whose work is intended for patients cannot merely impart facts. They also need to demonstrate that they…

Creating educational materials about clinical research data for patients and the public: A multifaceted journey in the current digital age - Volume 33, Issue

With scientific advances during the COVID- 19 pandemic and expansion of artificial intelligence (AI) in research, there has been a simultaneous increase in misinformation about data collection, privacy, and sharing in clinical trials. This increase h…

Medical Devices - Volume 33, Issue

Section Editor: Payal Bhatia EMWA’s medical device expert seminar series brings together speakers with different expertise providing valuable insights into the medical device industry. Medical device Expert Seminar Series: Beyond traditional…

Good clinical practice (GCP): A universal call for ethics in biomedical research - Volume 23, Issue

Today, the principles of good clinical practice (GCP) form such an integral part of the development of new medicines that they could easily be taken for granted. Yet, the road to a universal code of ethics in human experimentation is paved with…

Post-approval regulatory writing - Volume 23, Issue

Graphing software for medical writers - Volume 23, Issue

The production of high-quality graphical figures of scientific data is an important aspect of medical writing, since the significance of the research findings can be lost to the audience if the data are presented poorly or inaccurately. This…

“Follow the Sun” writing: A hybrid operating model to optimize collaboration and efficiency - Volume 33, Issue

Time, quality, and accuracy are of the essence for expeditious global regulatory submissions. An around-the-clock, 24/7, global medical writing model has been developed that allows efficient development of high-quality documents with appreciable…