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....
Journal: Medical Writing Supplement of International Clinical Trials, ICT
Date: February 2024
I did it so you don’t have to: Lessons learned as a young writer struggling with a regulatory document
Medical writing is not easy, especially for a new writer still learning the ropes. We are exposed to new documents, therapeutic areas, procedures, and challenges regularly and the fast-paced and...
How well-written clinical study protocols get drugs to patients faster
In the world of drug development and approval, time is of the essence. But beginning the process with a poorly written protocol will only impede teams before a study has even begun. Julia Forjanic Klapproth, co-founder of Trilogy Writing & Consulting, describes how a well-written protocol will help patients receive their treatments sooner rather than later.
The Lay Protocol Synopsis: Requirements and Feasibility
In 2014, the EU introduced a new regulation: EU CTR 536/2014.1 This regulation replaced the previous Clinical Trials Directive 2001/20/EC,2 and became mandatory with the opening of the Clinical Trials...
Clinical Study Protocols: The Pillars of Clinical Development
Welcome to the 2023 Medical Writing Supplement developed as a collaboration between Samedant Ltd and Trilogy Writing & Consulting and published as part of the Winter edition of International Clinical...
Journal: Special Edition of International Clinical Trials, ICT
Date: February 2023
The Future of Medical Writing: A Panel of One
Of all the points in the evolution of the medical writing profession, I believe we are at the pinnacle of what promises to be the most exciting and biggest paradigm...
Remote meetings made easy: Good practices to keep in mind
Abstract One core medical writing skill is effectively communicating with the teams that will help us author our documents. With remote working playing an increasingly important role in our workforce,...
Julia Forjanic Klapproth of Trilogy Writing and Consulting elucidates how strategic medical writingcan help communicate key messages across development programmes and make sure teamsstay focused on a common goal. I...
Streamlining meetings with regulatory authorities is a continually evolving process. But what role do briefing documents play, and what is the best way to produce these effectively?
How to streamline a complex process: why experienced medical writers will add value to oncology dossiers
Oncology is one of the most common areas of drug development in the pharmaceutical industry. In 2020, many of the new drugs approved by the FDA were cancer treatments. Existing...
The FDA, EMA, and PMDA Questions: How to Respond During Review of CTD Submission Dossiers
While the ICH’s Common Technical Document (CTD) is an internationally agreed format for preparing application dossiers needed for obtaining approval to market a drug, the ensuing review process is specific to the country or region in question. Irrespective of the differences in process between countries and regions, questions will almost always be issued during the review process, with a request for written responses.
