Ctrl+Alt+AI: Rebooting the Future of Medical Writing
Welcome to this special edition magazine created in collaboration between International Clinical Trials and Trilogy Writing & Consulting, an Indegene Company. This magazine explores how artificial intelligence (AI) is reshaping the medical writing...
Journal: Medical Writing Supplement of International Clinical Trials, ICT
Date: May, 2026
Navigating the skill shift: What does professional growth look like for AI-assisted medical writing?
The rapid expansion of artificial intelligence has prompted the evolution of skills needed to manage medical writing workflows. AI tools do not replace the expertise, judgment, or regulatory awareness required...
Artificial intelligence adoption is not a tech challenge only – it is a people journey and the organisations that master change are the ones that unlock real value. Lisa Chamberlain...
ICH M11 in practice: a new era of structured protocol authoring for medical writers
The ICH M11 guideline introduces a globally harmonised, structured approach to clinical trial protocol development, transforming medical writers from narrative authors into strategic, data-driven architects and redefining their role in...
Leadership Development for Medical Writers: Key Insights From the 2023-Present AMWA Educational Workshop
Angela Russell Winnier, PhD and Julia Forjanic Klapproth, PhD / Clinical Development and Operations Medical Writing, Pfizer, New York City, NY; Trilogy Writing and Consulting (an lndegene Company), Frankfurt, Germany...
The Evolving Role of Medical Writers: AI as a Partner in Regulatory Submissions
Lisa Chamberlain James and Julia Cooper / Trilogy Writing and Consulting, Cambridge, United Kingdom; Parexel International, Dublin, Ireland Abstract Medical writers play a crucial role in regulatory submissions, ensuring clarity, adherence to...
Madhobi Sen and Shawna Basin / Principal Medical Writer, Trilogy Writing & Consulting, an lndegene Company, Frankfurt, Germany; Senior Medical Writing Manager, Trilogy Writing & Consulting, an lndegene Company, Frankfurt, Germany We...
Smart and Efficient RFPs: A Vendor's Plea for Better Questions
By Douglas Fiebig, Senior Partner at Trilogy Writing & Consulting and Evija Kuemmel, Head of Corporate Communications at Trilogy Writing & Consulting When outsourcing services, designing and issuing a Request...
Harnessing real-world data: An advantage for medical device manufacturers
Crispin Bennet, Heidi Chapman and Laura C Collada Ali of Trilogy Writing & Consulting explore how it’s time for medical device manufacturers to harness the full potential of real-world data...
The evolution of strategic medical writing: a coming of age
How medical writing has shifted from a technical function to a strategic role in which writers act as specialists and advisors helping communicate key messages across documents and keeping teams...
The role of real-world evidence in post-market clinical follow-up
Post-market clinical follow-up (PMCF) is a mandatory, ongoing process under EU MDR 2017/745, aimed at ensuring the continued safety and performance of medical devices. This manuscript outlines the regulatory requirements,...
Real-world data coming into play in the medical device world: What medical writers need to know
The integration of real-world data (RWD) into healthcare decision-making has transformed various aspects of clinical research, regulatory approval, and post-market surveillance. As the healthcare landscape continues to evolve, the use...
AI in medical writing - tools, tantrums, and testimonies
This article explores the impact of artificial intelligence (AI) on medical writing from an insider’s perspective. It discusses the various AI tools available, and the practical benefits observed through real-world...
Visual aids in patient-focused drug development and routine clinical practice
Effective medical communication is critical for patient consent, adherence to treatment, and improved health outcomes. Visual aids, such as infographics, diagrams, and charts, have proven invaluable for enhancing comprehension, particularly...
Plain Language Summaries of Clinical Trial Results: What is their role, and should patients and AI be involved?
Plain language summaries (PLSs) of clinical trial results are vital tools in the clinical development process for enhancing transparency and encouraging and facilitating patient engagement. The production of a PLS...
Over the last 25 years, the way we write regulatory documents has evolved – from lean writing to technology that aids in populating the reports we write, things have gotten...
Keeping it lean: hitting the Goldilocks level of detail in medical writing
It is crucial to apply lean medical writing principles when drafting regulatory documents, to ensure they are as informative as possible while being concise and readable – how can this...
Does women's health matter, and is clinical development failing them?
Historically, women have largely been left out of clinical research. How has this harmed women-specific healthcare, and what can be done to ensure this doesn’t happen in the future? What...
In regulatory submission writing, a project facilitator is the yin to a medical writer's yang
Regulatory submission writing is an enormous and costly endeavour that begins during preclinical development and continues even after the product has been approved. Marketing applications encompass a series of documents...
Communicating With Patients: Why It Matters and How to Do It Better
Welcome to the Medical Writing Supplement of International Clinical Trials. We are delighted to present this edition, where we explore the landscape of communicating with patients and the general public....
