Note to File: A Clinical Research Podcast

Brad Hightower
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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.

  1. 21 JAN

    JPM, AI, & Cheese Lore

    Get ready for a flavorful kickoff to 2026 with the latest Note to File podcast! 🎙️ In this episode, Denali and Brad serve up laughter and insight—from opening with comedic banter and cheese puns (did you know it's National Cheese Lovers Day?) to swapping stories about their favorite cheeses and regional cheese culture. But that's just the appetizer! Dive into the latest trends from the JPM conference, including industry updates, M&A highlights (or the lack thereof), and debates on the real significance of company announcements in clinical research. The hosts weigh in on the rising role of AI—like Anthropic's Claude—in trial design, recruiting, and regulatory submissions, and raise thought-provoking questions about using AI with imperfect clinical data. The discussion gets real as they tackle the ethics of government-funded vaccine studies and the challenges of conducting clinical research in vulnerable populations. Plus, stick around for info on upcoming conferences, meetups, and the possibility of a live podcast stream from SCOPE! Whether you're a cheese connoisseur or a clinical trials pro, this episode has something for everyone. Don't forget to like, comment, and subscribe for more unfiltered coverage of the world of clinical research!

    30 min

  2. 19 JAN

    Dr. Les Enterline on CRO Partnerships, FSP Models, and Industry Innovation

    Denali and Brad welcome Dr. Les Enterline, a seasoned physician assistant and industry leader, to discuss the evolving landscape of CRO models—Full Service Outsourcing (FSO) vs. Functional Service Partnerships (FSP)—and their impact on sponsors, sites, and patients.  Discover: • Dr. Enterline's compelling career journey from clinical practice to industry leadership • The inner workings and real-world differences between full service and FSP models • How sponsors choose their approach—and what it means for site operations and staff retention • The vital role of partnership, communication, and empathy in successful research collaborations • Practical insights into how AI and technology are transforming clinical trial efficiency Whether you're a research professional, sponsor, or just curious about how groundbreaking therapies move from concept to clinic, this episode will equip you with valuable knowledge and perspective.

    52 min

  3. 19 JAN

    Bacon, Band Names, and Big Bets on AI

    In this New Year's special, we kick things off with gym woes, bacon vs. sausage debates, and a little dose of existential career crisis. Then it's on to the real meat: wild AI spin-outs, the hard truths about commercializing tech in trials, AstraZeneca's eye-opening drug recall, and bold (plus slightly pessimistic) predictions for 2026. A re rising healthcare costs going to split trial participation? Is the AI revolution real or just LinkedIn hype? And can New Year's resolutions actually stick in our industry? Join us for candid industry takes, unscripted nonsense, and a sprinkle of optimism (maybe). Don't forget to comment with your resolutions, predictions—or just your favorite breakfast meat!

    39 min

  4. 19 JAN

    Socks, Sites, and the Trouble with FDA Guidance

    Join Denali and Brad as we mix a little fun with some real industry insight. We kick things off with light commentary on oddball holidays before diving into the big issues in clinical research—recent FDA guidance, the ongoing push for site- and patient-centricity, and ways to make trials more inclusive. Listen in for our honest takes and predictions for 2026, including thoughts on AI, DEI, and what the future really looks like for clinical trials. As always, the conversation is open, genuine, and full of practical perspective—with a few laughs along the way. If you're interested in what's changing, what still needs work, or you just want the inside scoop on the real world of clinical research, this episode is for you.

    34 min

  5. 19 JAN

    Bop It, Buy It, Bet on AI: Trials, Toys & Turmoil

    In this episode of Note to File, Denali and Brad go deep on National Stupid Toy Day: from Tamagotchis and Furbys to pet rocks and that one toy guaranteed to make your parents question their life choices. What's your favorite stupid toy? Tell us. We want to laugh (or cringe) with you. But it's not all just fun and games—we break down the big moves in the clinical research industry: Paradigm Health's acquisition of Flat Iron's clinical research business. Is it a stroke of master planning, or just companies winging it and hoping for synergy? We ask the tough questions, debate if anyone actually knows what these companies do, and barely resist launching a live Bop It tournament. Stick around as we fire up our (not-so) prophetic skills for 2026 predictions: CROs, AI, site tech stacks, FDA regulations, and why "efficiency" might be the word of the year—but will anyone actually deliver? Expect honest hot takes, zero fluff, and plenty of sideways glances at industry PR-speak. Whether you're decking the halls or just dodging winter yard work, this one's for you. Subscribe for unfiltered conversations, industry nonsense, and the stuff nobody else will say out loud.

    34 min

  6. 19 JAN

    Deadlines, Data, and Debacles: Year-End Reflections in Research

    In this episode of Note to File, Denali and Brad navigate the strange limbo between holiday distractions and end-of-year clinical trial deadlines, sharing the whiplash of a research life in December.  Join us for candid takes on the FDA's rumored pivot to fewer, tougher trials—will it shake up the industry, save time, or just add confusion? We unpack what "site irregularities" really mean (and how much the public ever finds out), riff on the never-ending debate over Big Pharma's reputation, and marvel at the lengths some of us go to avoid awkward airport conversations about what we actually do for a living. Plus: marine biology dreams, random whale facts, and an open call for guests who want to jump into the clinical research conversation.  Tune in for a mix of humor, honesty, and real talk about what's next for clinical trials.

    28 min

  7. 19 JAN

    Patient-Led Revolution: Susannah Fox on Rare Disease, Peer Networks & Rethinking Clinical Trials

    Join Denali and Brad for another episode of the Note to File podcast—where clinical research meets candid conversation, friendly banter, and the occasional deep-dive into paper towel dispensers. In this episode, we welcome the always-insightful Susannah Fox, self-described "internet geologist" and champion of patient-led innovation in healthcare. Tune in as we swap stories of networking mishaps, pandemic-induced introversion, and the real deal behind patient involvement in clinical trials. Susannah shares her journey from rare disease events to the White House, plus practical lessons on listening to communities, engaging peer networks, and reimagining what "patient-centered" should truly mean. Whether you're a curious researcher, a healthcare professional, or just love a good conversation, you'll find something to think about (and probably laugh about) in this episode. Subscribe for more interviews, commentary, and general nonsense for the clinical research community!

    43 min

  8. 05/12/2025

    50k, Fake "Landmarks," R&D Cuts & Can You Teach Common Sense?

    Welcome to another "Sticky Notes" live session of Note to File – the only clinical research podcast that's part insightful conversation, part general nonsense. Today, we're braving the December chill, celebrating a totally wild (and possibly confusing) 50k YouTube subscribers, and pondering whether people forget how to drive in snow every single year (spoiler: they do). We dig into the latest so-called "landmark" UK/US pharma trade deal (cue eye rolling at historic headlines), the gritty truths about public sector R&D cuts, and why axing funding and getting stingy on immigration probably isn't how you keep America "exceptional." Don't worry, we squeeze in healthy skepticism, plenty of hot takes, and our usual professional-grade side eyes for political "bravery." Plus, we get philosophical on whether critical thinking can actually be taught—or if some folks are just destined to be, let's say, less-than-critical. If you somehow still believe in innovation, or if you want to listen to clinical research pros vent about the stuff no one else says out loud, you're in exactly the right place. Smash that subscribe button, drop us a comment, and let us know what you want us to rant about next. Thanks for being one of the "hardcore of the hardcore."

    29 min
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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.

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