TriloTalk

AI is transforming medical writing, but how do you build a solution that's trusted enough to support high-stakes work? In this episode of TriloTalk, Lisa Chamberlain James, VP Medical Solutions, and Tarun Mathur, Chief Technology Officer at Indegene take you behind the scenes of NEXT Medical Writing Automation to explore the philosophy, decisions, and safeguards that shaped its development. Hear how NEXT MWA balances speed with compliance, transparency with innovation, and why keeping humans in control remains central to the future of AI-powered medical writing.

Short on time? We’ve condensed five valuable medical writing lessons into one quick 10-minute episode. We explore mentorship, purposeful writing, patient-focused communication, medical device document challenges, and translation considerations.

This episode of TriloTalk explores how health literacy goes far beyond simplifying language. It requires consistency, testing, and truly meeting patients where they are. Poor communication can have serious consequences, from medication misuse to reduced trust and engagement in clinical trials. Lisa Chamberlain James, Senior Partner at Trilogy, Elizabeth Brown, Executive Director Clinical Transparency at Merck, and Maureen Kashuba, Senior Director Health Literacy at Merck, discuss this and the importance of partnering together, regardless of what organization you are a part of, to best serve patients across the world.

What does it really take to move into leadership in medical writing? Nidhi Johal, Medical Writing Manager of North America, and Kleopatra Kouroupaki, Senior Medical Writing manager, explore just that in this TriloTalk episode. They cover real-life paths, how to effectively manage former peers, lessons behind career growth, and much more. Listen up!

Everyone is talking about “one-click AI,” but is it real or just a conference buzzword? In this episode of TriloTalk, Lisa Chamberlain James, Senior Partner at Trilogy, and Vladimir Penkrat, Associate VP Regulatory Affairs at Indegene, cut through the hype and explore what AI can actually do today in medical writing and regulatory affairs, where the biggest gaps are, and how organizations can actually make real progress.

This episode of TriloTalk explores companion diagnostics and what makes them medical devices. Join Julia Forjanic Klapproth, Senior Partner at Trilogy, Laura Collada, Senior Medical Writing Manager at Trilogy, and Raquel Billiones, Director of Medical Writing at AstraZeneca and learn how in vitro diagnostic tools help pair the right treatment with the right patient and why we can’t just test drugs and their companion devices all in one go. Tune in!

Humans communicate through stories and medical writers help teams crystallize the story out of the data: this is the essence of what they bring to the table. Join Julia Forjanic Klapproth, Senior Partner at Trilogy Writing & Consulting, and Eleanor Steele, a freelance consultant working as the Med Comms Mentor, for TriloTalk episode 39 where they explore the power of storytelling in medical writing and explain the PRISM framework, which is a useful system for medical writers to make each story hit the mark.

For TriloTalk episode 38, Lisa Chamberlain James, Senior Partner at Trilogy, and Sudipta Chakraborty, Head of Literacy & Plain Language Center of Excellence at Biogen, talk about how to use AI in the creation of lay summaries of clinical trial results. Scalability, change management, prompting, biases, realistic attitudes, and human involvement are all touched on so listen up!

TriloTalk episode 37 focuses on a specific type of medical device, the drug-delivery system. Writing for drug-delivery systems is all about being fluent in two languages – drugs and devices. Julia Forjanic Klapproth, Senior Partner at Trilogy, Laura Collada, Senior Medical Writing Manager at Trilogy, and Raquel Billiones, Director of Medical Writing at AstraZeneca, talk about this and what medical writers need to understand when crafting these regulatory documents.

Clinical trial transparency is a delicate balance of getting the right data to the right resources at the right time. Senior Partner Lisa Chamberlain James sits down with the President of Holtzople Consulting, Julie Holtzople, to discuss how to do just that. They discuss standardizing information for researchers, building trust, advice for best practices, and whether all this transparency is legally mandated – or simply the right thing to do.

The demand for experienced medical writers is outpacing the availability of experienced writers. In TriloTalk episode 35, Julia Forjanic Klapproth, Senior Partner at Trilogy, and Kim Jochman, Senior Director of Medical Writing at Merck, raise awareness of two new essential AMWA resources: the apprentice program framework and the job leveling framework. As members of the workstreams who developed these, Julia and Kim bring insights and the rationale from behind the scenes. Tune in and learn about these important initiatives for the medical writing community.

For episode 34 of the TriloTalk podcast, Lisa Chamberlain James, Senior Partner at Trilogy, sits down with the AI Agent expert Nikesh Shah, VP and Global Head, Generative AI at Indegene. They discuss everything you need to know about AI Agents – the day-to-day usage, project confidentiality, when it will become mainstream, which industries are using it now, and how it will enrich our lives. It's an episode you don’t want to miss!

This episode focuses on writing for medical devices. Playing Sherlock Holmes, conducting usability studies, following regulations, working closely with the manufacturers and much more are all in a day's work when writing for devices. Listen to Trilogy's medical writing managers, Heidi Chapman and Laura Collada, and Senior Partner, Julia Forjanic Klapproth, discuss the similarities and differences between writing for devices and writing for drugs. Listen up!

The Informed Consent Form is a participant’s first impression of a clinical trial so Lisa Chamberlain James and Ros Cheetham sit down to discuss how to make it the best it can be. Learn about the layout, formatting, crafting tips, where plain language fits in, and its future.

Join Julia Forjanic Klapproth as she gives a useful overview of what everyone is talking about these days – AI agents. You’ll hear about the benefits they bring and their limitations, how it will dramatically change everyone’s day-to-day work, and what this means for the medical writing world.

It’s International Day of Women and Girls in Science! To celebrate, TriloTalk episode 30 is a conversation with Trilogy’s two female Senior Partners discussing what sparked their interest in science, barriers to entry (or lack thereof), clinical research gaps, female representation in the medical writing industry and more. Listen up!

The rapidly growing industry of regulatory medical writing calls for a 2025 prediction podcast! Listen up for “What’s Hot and What’s Not” from our experts Lisa Chamberlain James, Julia Forjanic Klapproth and Sonica Batra and get a glimpse of what Trilogy, an Indegene Company and Indegene will be up to this year.

Long time friends and industry colleagues, Lisa Chamberlain James with Trilogy and Cheryl Roberts with BioMarin Pharmaceutical sit down to discuss orphan drugs. They go over clinical trial hurdles, key incentives for health authorities, the medical writing process and start with an important question – why are orphan drugs called orphan drugs? Find out on episode 28 of TriloTalk!

Join Julia Forjanic Klapproth, Barbara Boggetti, and Bhawna Basin as they take a closer look into Clinical Overviews. Since many agree it’s one of the most interesting documents medical writers prepare, they dive right into many topics like strategy, FDA vs EMA requirements, graphics, working with sponsors, and even page count challenges. Listen up!

Welcome back to TriloTalk! In this episode, Lisa Chamberlain James from Trilogy and Vladimir Penkrat and Ritesh Dogra from Indegene dive into the role and future of lay summaries. AI technology, new EUCTR requirements, graphic creation, and much more will affect how medical writers create patient-friendly language documents. Tune in to gain valuable insights and tips on how to navigate this changing environment.