TriloTalk

Join Julia and Jonathan for the 2nd part of a discussion dedicated to the development of Clinical Study Protocols, as they delve into the intricacies of writing these crucial documents. In this discussion, they explore the level of involvement a writer should have to ensure a well-written protocol. Tune in to gain valuable insights and guidance on creating effective protocols that drive successful...

In this episode, our host, Julia Forjanic Klapproth, and our special guest, Angela Winnier, Senior Director, Medical Writing Lead for Rare Disease at Pfizer, come together to share their conviction and valuable experiences as medical writing leaders. Join them as they dive into the crucial topic of organizations providing training that goes beyond technical writing skills. Together, they will expl...

In this special episode, Lisa and Barry, Senior Partners at Trilogy, along with Jamie Norman, Chief Product Officer at TriloDocs joined Network Pharma at its webinar: AI for Medical Writing, Turkeys voting for Christmas? During this thought-provoking conversation, they explored and explained the potential impact of AI on medical writing, discussed the opportunities and challenges that come with in...

Welcome to TriloTalk episode 15, where we will dive into the critical document that plays a pivotal role in pharmaceutical development: The Briefing Documents (or briefing books/packs). Join Barry and Maria as they explore the key elements of well-crafted Briefing Books, their importance in the regulatory process, and how to tailor these documents to the specific regulatory authority. 

In this episode, Julia and Jonathan cover how making people aware of the many new and updated regulations (such as the ICH E8(R1) and the draft ICH M11 guideline) will help ensure teams are following these, looking for ways to handle the ever more complex studies that are being designed, the importance of focusing on the regulatory objectives of a study over more academic pursuits, the value of us...

In this special session of TriloTalk, Julia and Barry answer questions sent to them by medical writers around the world. The focus of the questions in this episode is Clinical Study Reports (CSRs), data reporting, and analysis.  Tap into Julia’s and Barry’s vast medical writing experience and make sure to send your questions for future sessions of “Q&A with TriloTalk” to writers@TrilogyWriting...

In this episode, Lisa Chamberlain James, Senior Partner at Trilogy Writing & Consulting talks to Dan Wills, Quality Mark Manager at Patient Information Forum (PIF) about the PIF TICK accreditation and its importance – specifically, what it means for organizations to have this certification mark and what it means for people in their search for high-quality health information.

Process optimization, effective management, and organisation strategies are all essential components when preparing CTD submission dossiers for drug approval.  In this episode, Douglas, Senior Partner at Trilogy Writing & Consulting, and Johan Telen, President at Improvement at Work, discuss how implementing well-planned, focused, and robust processes can actively de-risk the critical path and...

Restrictive or time-saving? In this episode, Barry reflects on the importance of style guides and how these can serve as a compass to accompany medical writers when deciding on the grammatical or stylistic rules that need to be applied to the documents they are writing. Style guides not only save time (and money) in the writing process but also help improve the document review process. You might a...

Rapid dissemination of scientific information, lower standards in review processes, unvetted information. In this episode, Barry and Art explore the never-ending ethical situations that are deep-rooted in the profession of medical writing.

In this episode, Julia and Douglas, Senior Partners at Trilogy Writing & Consulting, discuss how preparing written responses to questions received from regulatory agencies during the review of application dossiers can be decisive to the outcome of the review, and how medical writers can make a substantial contribution to this process.

In this episode, Julia Forjanic Klapproth - Senior Partner, and Maurice Löwens - Medical Writing Manager at Trilogy Writing, discuss how experienced medical writers can streamline the planning and writing process, helping the team navigate a minefield of potential problems and letting the subject matter experts spend more time on crafting the messages.

In this month’s episode, Julia Forjanic Klapproth, Senior Partner at Trilogy Writing & Consulting, and Joan Affleck, Head of the Medical Writing Department at Merck, talk about the medical writing training programs at the companies they represent and explore how training medical writers help build a brighter future and lift the entire profession of medical writing. Listen now

Writing for a non-specialist audience represents challenges beyond writing in a simpler language. Writing a fit-for-purpose document for the general public involves lay language, lay presentation, and lay science. Join Dr. Lisa Chamberlain James and Dr. Barry Drees as they discuss their knowledge and experiences in writing Lay Summaries.

In this episode, Julia and Barry, senior partners at Trilogy Writing & Consulting, call for a “revolution and complete overhaul in the way documents are reviewed”. They explain how a focused review process leads to a transformational change in how drugs get approved. Listen now.

“Pay me now or pay me later”. TriloTalk episode 3 features Dr. Julia Forjanic Klapproth and Gretchen Griffin as they talk and discuss the value of medical writing and what a good medical writer brings to the table.

Will AI replace or assist medical writers? Join Julia and Barry in this episode as they talk about how AI is going to change the way we write and work as medical writers. You will discover how AI will make writing clinical documents not only faster and more interesting but will aid with the analysis and eliminate human error. Get a sneak-peek into the coming revolution in medical writing. 

In this episode, Julia and Barry talk about the importance of lean medical writing to communicate the key messages efficiently. The goal is story, not storage. They discuss how less is more and the importance of giving answers to the questions posed by studies, rather than just spewing data. Lean writing is at the core of how to take aim at inefficient medical writing.