TriloTalk

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.  

In this episode, Julia Forjanic Klapproth and Lisa Chamberlain James from Trilogy and Vladimir Penkrat and Tarun Mathur from Indegene chat about the intersection of AI and medical writing. They cover historical evolution, current needs, automation strategies, essential skills, regulatory compliance, and unique use cases. Tune in to catch the insights and join the conversation!  

Welcome to Trilotalk Episode 24! In this episode, Douglas and Nidhi will take you through an overview of the recently introduced EU-CTR (Clinical Trial Regulation) - a hot topic in our industry these days! As medical writers, we need to be aware of not only what the EU-CTR is but also how it impacts the documents we often write. Join us to find out more about it! We will talk about what the EU-CTR is, the pros and cons of the new process, how a CTA in the EU is structured, and touch upon associated transparency and public disclosure requirements.

Welcome back to TriloTalk! As promised, we are continuing the conversation about buzzwords in medical writing. In this episode, our guests Lisa and Art explore the topic of medical writing and artificial intelligence in Part II of our series, 'Speaking of Buzzwords in Medical Writing'. Beyond mere catchphrases, they will reflect on the trending use of generative AI, its benefits and potential pitfalls, and the evolving role of medical writers. Happy podcasting! 

In this episode, Lisa Chamberlain James, Senior Partner at Trilogy Writing & Consulting, and Art Gertel, Principal at MedSciCom, discuss the pivotal role of patients in pharmaceutical decision-making. Despite knowing the importance of patient-centricity, their perspectives are frequently overlooked in crucial stages of drug development. How can pharmaceutical companies integrate patients' unique insights to enhance their processes? Tune in as they engage in this vital discussion.Interested in exploring the topic ‘Communicating with patients' deeper and beyond our podcast episode? Here's the link to our dedicated Medical Writing Supplement of ICT on this very topic. Also, stay tuned for Part II of Lisa and Art's conversation in Episode 23, coming up in April 2024.

 Join Nidhi Johal, Director of Medical Writing for North America at Trilogy Writing & Consulting, and Heidi Chapman, Medical Writing Manager at Trilogy in a conversation about a topic that resonates with professionals across the industry – burnout. In this episode, Nidhi and Heidi draw from their own experiences, sharing personal stories, exploring the signs of burnout, and helping listeners identify red flags early on. From setting boundaries to embracing self-care practices, they discuss practical strategies they've learned to prevent burnout, ensuring a healthy work-life balance. Whether you're a seasoned writer or just stepping into the world of medical writing, this episode provides valuable insights to keep you thriving in this profession. Happy listening! 

In this episode, Julia and Lisa take a deep dive into General Medical Writing Principles. Join them as they navigate through a diverse range of topics that are crucial in the everyday practice of crafting clear and concise regulatory documents. Our hosts will generously share their personal insights, experiences, and invaluable tips that have positioned them as Masters in the field of medical writing. Happy podcasting! 

In this episode, Lisa Chamberlain James, Senior Partner at Trilogy Writing & Consulting, and Magnolia Correa, Marketing Communications Manager at Trilogy Writing & Consulting, delve into their shared passion for patient communication. They explore this topic from their different perspectives and discuss how medical writers contribute to enhancing health outcomes by crafting clear and impartial documents intended for the general public. 

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 clinical studies.

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 explore the significance of creating “safe spaces” where medical writers can truly spread their wings and thrive. 

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 integrating AI into the field, and shared their expert insights on how to navigate the rapidly changing environment.

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 using the Transcelerate template to get more standardization across the industry, and the importance of preparing protocols that communicate clearly and effectively not only to help users find the information they need but also to ensure teams are aligned on the full intentions of the study and for downstream use of the protocols in writing study reports and ultimately dossiers. 

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.com.

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 contribute to reducing the time needed for dossier preparation.

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 also like to listen to Episode 4: The Power of Good Review Practice."Style guides will not only improve your writing but greatly improve your review processes."

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.