Claim OwnershipNote to File: A Clinical Research Podcast
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Note to File is a podcast for clinical research sites - interviews, best practices, and candid commentary from Brad Hightower, founder of Hightower Clinical and clinical research professional.
137 Episodes
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In this episode, Denali and Brad sit down with Del Smith, founder of Acclinate, to explore the challenges and opportunities in increasing representation in clinical research. They discuss the intersection of technology and trust, the importance of community-first approaches, the role of sites and sponsors, and offer actionable tips for sites of all sizes. Del shares his personal journey from business school dean to healthcare entrepreneur, highlighting real-world solutions for building trust and engagement in underrepresented communities.
Join us for an insightful conversation with Walt Bogdanich, three-time Pulitzer Prize-winning investigative reporter from The New York Times, as we dive deep into the world of clinical research oversight. Walt discusses his investigations into institutional review boards (IRBs), the growing influence of private equity in healthcare, transparency issues within drug trials, and the broader implications for patient safety and trust in medical innovation. Whether you're a clinical researcher, healthcare professional, or simply interested in the intersection of medicine, business, and ethics, this episode offers eye-opening stories and critical perspectives you won't want to miss.
Denali and Brad talk about horror movies, take a deep dive into the real experiences of clinical research coordinators, and discuss whether degrees or work experience matter more. We also explore the environmental impact of clinical trials, issues of trust in research roles, and take a look at Nike's latest innovation—motorized sneakers. Join us for thoughtful discussion and some lighthearted moments.
Denali and Brad tackle a wide range of critical topics in clinical research. We dive deep into the realities of CRA burnout, the shifting landscape of global clinical trials, and the implications of the U.S. focusing more on manufacturing than R&D. We also explore the challenges faced by patients navigating site errors and expanded access, discuss how technology and AI are changing the field, and reflect on the human element that underpins the industry. Along the way, you'll hear honest perspectives, industry insights, and some lighthearted banter—including a surprise appearance from a feline friend. Whether you're a clinical research professional, a patient advocate, or simply curious about what happens behind the scenes, this episode offers an engaging look at the current and future state of clinical trials. Subscribe for weekly insights, guest interviews, and real talk about the topics that matter most in research.
In this episode, Denali and Brad welcome Doug Bain (ClinFlo) for a no-holds-barred chat about why site tech still stinks, EDC headaches, AI hype (and hope), platform silos, and why so many research sites are still using sticky notes for passwords. From the joys of Italian coffee breaks to Black Mirror references, Doug shares war stories, practical fixes, and predictions for where real change might finally happen. If you've ever wondered why clinical research tech feels 20 years behind (and how AI could actually help), don't miss this episode!
In this episode, we dive deep into the growing influence of private equity on Institutional Review Boards (IRBs), the challenges of maintaining transparency and avoiding conflicts of interest, and the explosion of data collection in modern clinical trials. We also discuss the promises and pitfalls of AI in research, share personal stories from the field, and reflect on the latest industry news and conferences.
Join us for a special episode recorded live at the ING conference in Westchester! Denali and Brad dive into the unique format of this innovative clinical research event, from TEDx-style main stage talks to collaborative dive teams and the exciting whale tank for startups. We discuss the latest New York Times article on private equity's impact on research ethics, memorable sessions (including Catherine Gregor's insights on site burden), and the importance of breaking down silos in the industry. Plus, get a behind-the-scenes look at the social events, the conference's growth, and what makes ING a must-attend for clinical research professionals.
Join us for "Sticky Notes" edition of the Note to File podcast! In this episode, we celebrate National Research Administrator Day, dive into the growing complexity of data collection in clinical research, and discuss the surprising ways the Family and Medical Leave Act supports clinical trial participants. We also explore the results of the first-ever ACRP national workforce survey and reflect on the challenges and opportunities for collaboration and innovation in the clinical research industry
Join Denali and Brad on the Note to File podcast as they welcome Liz Beatty (Co-Founder & Chief Strategy Officer, Inato) and Jovani Rivera (Site Director & Founder, Novum Research) for an in-depth discussion on the evolving landscape of clinical research technology. In this episode, they explore how AI and innovative tech are streamlining patient pre-screening, reducing administrative burdens, and improving site efficiency—while keeping the human element at the forefront. Discover the challenges and solutions around integrating new tools with existing systems like EHR and CTMS, the complexities of patient record retrieval, and the importance of real site feedback in product development. The conversation also delves into protocol design, vendor selection, and the future of tech adoption in both independent and academic research centers. Whether you're a clinical research professional, tech enthusiast, or just curious about the intersection of healthcare and innovation, this episode offers valuable insights and practical advice for navigating the rapidly changing world of clinical trials.
In this lively discussion, Brad and Denali and guests, Dan Schell and Katlyn Delaney, dive into the latest happenings in clinical research, including highlights from the DPharm conference, the evolving role of sites and vendors, and the challenges of EHR/EDC integration. We explore the real-world impact of AI and automation on patient outreach and pre-screening, and share candid thoughts on industry buzzwords, vendor relationships, and the future of clinical trials. Plus, hear personal stories, conference takeaways, and what's next for the clinical research community.
In this episode, Brad and Denali dive into the biggest news shaking up the clinical research world, including Novo Nordisk's historic layoffs and what it means for the industry. We break down the FDA's new crackdown on pharmaceutical advertising and discuss how upcoming reforms could change the way drugs are marketed to consumers. We also spotlight the ACRP's initiative to formally recognize clinical research professionals and what that could mean for the future of the field. Plus, we take a critical look at the rise of course-selling culture in clinical research, with a special mention of the mysterious "Pharma TNT" group. Stick around for updates on our upcoming round robin episode—if you want to join the conversation, find out how to get involved! Don't forget to like, comment, and subscribe for more unfiltered coverage of the clinical trial industry.
Join Denali and Brad for a special recap of the SOS Regional Meetup! We're joined by Ashley Margo and Monica Cultiva as we dive into what makes SOS events unique—focusing on community, open conversation, and real connections in the clinical research world. Hear how regional meetups differ from big conferences, why a relaxed environment sparks better ideas, and what's coming up next for SOS, including the Houston event and the 2025 conference. Learn how you can get involved, submit your ideas, or even become a speaker.
Live from the Veeva Summit, this episode dives into the latest trends and key takeaways from one of the industry's biggest events. Denali and Brad discuss the importance of bringing together sponsors, sites, and stakeholders to foster real conversations and collaboration. Highlights include insights from the Veeva keynote, the launch of Veeva AI and CTMS, and reflections on the evolving landscape of clinical research technology.
Dr. Daniel Fox join Denali and Brad as he shares expert insights on clinical research site management, financial best practices, and common pitfalls. Learn about the three pillars of site operations, strategies for financial health, and Dr. Fox's new textbook designed for site administrators. Perfect for research professionals looking to optimize their site's success!
In this episode, Denali and Brad discuss the upcoming Veeva R&D Summit, analyze the new partnership between Veeva and IQVIA, and explore Pluto Health's launch of the "Care on Deck" platform. They also review WCG's Total Training solution and share candid insights on clinical trial awareness, site engagement, and the evolving landscape of clinical research.
This week, we are joined by Maria P Ladd, a passionate site advocate, and Emerson Lebleu, founder of a new project management platform built specifically for research sites. In this episode, you'll hear: Real talk about the challenges clinical research sites face and why advocacy matters Maria's journey from consultant to full-time site champion and her mission to build a supportive community for sites Emerson's story of creating a technology platform designed to streamline site operations and improve transparency Honest discussion about budgets, site recognition, and the need for industry-wide collaboration Tips for site owners, PIs, and anyone interested in making research sites stronger and more sustainable Whether you're a site owner, sponsor, CRO, or just curious about the clinical research industry, this episode is packed with insights, inspiration, and actionable ideas.
In this episode, we dive into a little bit of everything from the world of clinical research. Join us as we discuss the latest buzz around Advarra's new AI tool, the real challenges of protocol design, and the ongoing debate about data ownership in clinical trials. We also share behind-the-scenes stories about site selection, the unique (and sometimes hilarious) working conditions of CRAs, and the everyday realities faced by research professionals.
Join us for an insightful conversation with Dr. Manfred Stapff, author of "Real World Evidence Unveiled: Navigating the Maze of Modern Misinformation." In this episode, we explore the differences between clinical trials and real-world evidence, the challenges of translating research into everyday medical practice, and the importance of diversity in clinical studies. Dr. Stapff discusses the growing problem of misinformation in medicine and media, the role of AI in both spreading and combating false information, and the ethical questions surrounding data privacy and ownership. Check his book here:https://a.co/d/ishaCNI
In this episode, Leapcure's Zach Gobst joins us as we dive into patient recruitment challenges, site frustrations and successes, protocol design pitfalls, the evolving role of CROs, and the impact (and hype) of AI in the industry. We also discuss the latest FDA guidance, decentralized clinical trials (DCT), and the importance of honest, unfiltered conversations—both in podcasting and in the clinical research community.
In this episode, we dive deep into the evolving landscape of clinical research. Join us as we discuss participant compensation in clinical trials, including payment trends, tax and benefit challenges, and new legislative efforts. We also explore global shifts in research, with a spotlight on China and international investments, and examine the ongoing underfunding, and recent breakthroughs, in women's health research. Tune in for candid insights, real-world experiences, and the latest updates shaping the future of clinical trials.
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