Type: Publications

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...

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...

We all know that artificial intelligence (AI) is changing the world we live in, and the world of medical writing is no different. The explosion of AI is creating significant...

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...

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....

Medical writing is not easy, especially for new writers still learning the ropes. We are exposed to new documents, therapeutic areas, procedures, and challenges regularly and the fast-paced and ever-changing...

Artificial Intelligence (AI) is beginning to affect almost every industry, and medical writing is no different. But how does this relate to our industry? How will AI affect medical writers? What’s already available and what is in the pipeline? Should medical writers be happy and embrace the technology, or should we resist as much as we can, assuming that we will all be replaced by machines? This article discusses the current state of the art of AI in medical writing and asks the question: AI for medical writers – friend or foe?

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.

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...

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...

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...

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?

In an earlier article about artificial intelligence (AI) for medical writing1, I stressed that AI tools would assist, accelerate and augment the process of clinical documentation. I also argued that the key to the third aspect, augmentation, was the use and future acceptance of standard texts.

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...

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.

The COVID-19 pandemic has significantly impacted the whole world and the public has had to struggle with understanding scientific data on a daily basis. The impact of scientific misunderstanding became painfully apparent with the decline in vaccine uptake and so the need for clear, understandable scientific information has never been more vital.

Clinical study protocols are important cornerstones on the journey of collecting the clinical data needed to elucidate the benefit-risk profile of medical treatments/devices. Not only do they lay down the plan for the study at hand, they serve as a repository of knowledge for the strategic intentions and will be used for multiple down-stream activities. They are the basis for trial registration, provide guidance to those running the study, and will be used by participants, ethics committees/institutional review boards, funders, regulators, journal editors, and systematic reviewers to appraise the study.

The most difficult task an author can face is clearly summarising a complex and data-filled clinical regulatory document and explaining the data. Barry Drees, co-founder and senior partner of Trilogy Writing & Consulting, discusses the recent concept of ‘lean medical writing’ (LMW), and how it is being implemented and used in the pharmaceutical industry.