Note to File: A Clinical Research Podcast

From raccoons with thumbs to $3.5B drug factories, this Sticky Note goes from absurd to deadly serious pretty fast. In this episode, we dig into three big themes shaping the future of clinical research: 1. Lilly's $3.5B U.S. Manufacturing Bet New mega‑facility in Pennsylvania and three more planned in the U.S. How policy, tariffs, and incentives are pulling drug manufacturing back onshore What this means for historically industrial regions that lost manufacturing jobs 2. China's Clinical Trial Explosion China now accounts for ~30% of global clinical trials Trials reported as 50–60% cheaper and 60–70% faster than in the U.S. Regulatory shifts, trial infrastructure, and why the U.S. may get left behind on the "science" side while focusing on manufacturing 3. The Hard Reality of Community Oncology Research Why oncology trials in community settings are so hard to run Inclusion/exclusion challenges, timing of care, and tiny eligible populations Financial reality for IROs/site networks vs. the clear ethical need for community oncology trials Plus: Burnout in clinical research and why it's under‑recognized at the site level SOS Conference in San Diego, what to expect, and why the vibe matters A brief detour into exotic pets, tarantulas, and weaponized raccoons (you've been warned) If you care about where trials get run, who gets access, and how policy quietly reshapes our entire ecosystem, this one's for you.

In this episode of Sticky Notes, Brad and Denali debrief from the VIVE conference in LA, where they discovered just how little most health systems, CIOs, and IT vendors really understand about clinical research. From translating basic terms like CTMS and CRC into plain language, to explaining why research even matters to hospitals and health plans, we dig into the massive awareness gap between care delivery and clinical trials. We also get into: -Why research divisions inside hospitals are often ignored or siloed -How vendor messaging has to completely change when talking to health systems -The rise of real-world data (RWD), claims data, and EHR data in regulatory decisions -New FDA guidance on Bayesian statistics and using historical data -The shift toward one pivotal trial and what that could mean for sites, CROs, and sponsors -Whether we're trying everything except just running better randomized clinical trials -How conference culture is changing – from hard-sell BD apps to real community (looking at you, Save Our Sites) Plus, in true Sticky Notes fashion, there's some talk about National Pistachio Day, renting guitars to shred at conferences, and why pistachios look weird but still slap.

In this episode of Note to File, Denali and Brad sit down with Dr. Brad Hall, founder of Senge, a boutique CRO focused on investigator-initiated trials (IITs) in eye care. They break down how independent clinicians can turn real-world questions from daily practice into publishable clinical research. In this conversation, we cover: -Why most IITs in eye care actually happen in private practice, not academia -The biggest barriers independent clinics face (time, staff, IRB, budget) -How to start with retrospective studies and build toward prospective IITs -Funding options and how to partner with industry for real-world data -Practical pros and cons of paper vs. EDC for small IITs -Dr. Hall's LENS system from his book Idea to Impact: -Launch with focus – defining the question, protocol, and consent -Enroll with confidence – recruiting and retaining patients -Notice the insights – collecting clean data and analyzing it -Share the results – publishing and presenting your work If you're an eye care provider (or any specialist) who's ever thought, "I see this pattern in my patients—could I turn this into a study?" this episode will show you what it actually takes to go from idea to impact.

-Are CROs "necessary evil" partners or overhyped money machines — and what does ICON's 50% stock plunge really tell us about the state of clinical research? In this Sticky Notes episode of Note to File, we riff on everything from conferences and culture to credibility and regulation in our industry, including: -ICON's revenue overstatement and the brutal market reaction -What a 2% revenue error really means for trust, transparency, and CRO credibility -The strange love/hate dynamic around CROs on LinkedIn, Reddit, and in the trenches -How health system execs still don't really "get" research — and why that matters -The massive gap between research professionals and healthcare executives at conferences like VIVE and Scope -Whether the FDA could streamline oversight for low-risk trials without new legislation -Why risk-based monitoring and "common sense" regulation still haven't truly shown up at the site level -The paradox of an industry that bets billions on long-shot drugs but is terrified of operational innovation -Sponsors as the real power center: why nothing changes until sponsors want it to If you're a site, sponsor, CRO, or just a research nerd trying to make sense of where this industry is headed, this one's for you.

Live from SCOPE in Orlando, we're talking honestly about the clinical research conference circuit—what works, what doesn't, and why it all feels a little… exhausting. In this episode of Note to File, we cover: -What it's really like navigating a 5,000‑person conference with 200+ vendors -Why every year we hear the same challenges in clinical research, over and over -How the AI hype is shifting from marketing buzzwords to actual use cases -The strange "conference economy" (big booths, big spends, but are we solving real problems?) -Why more sites are showing up at SCOPE—and how they're using it for BD -The pros and cons of massive conferences vs. smaller, content‑driven meetings Along the way, we talk: -Tattoo booths and disappearing egg rolls -The grind of back‑to‑back conferences -What hosting our own conference (SOS) taught us about how events should work for sites, sponsors, and CROs. If you work in clinical operations, at a site, sponsor, or CRO, this is a candid look at what these conferences are actually doing for the industry—and what they're not.

In this Sticky Notes episode of the Note to File podcast, Brad and Denali dig into Walmart's new partnership with Care Access to launch clinical research sites inside shuttered Walmart health clinics. We talk about: -Why Walmart is re-entering clinical research now -How shuttered retail clinics are being repurposed as research sites -The broader story of retail pharmacies (Walmart, Walgreens, CVS, Kroger) jumping into — and out of — clinical trials -The role of government research grants and public–private partnerships -Whether retail giants should really be acting as research sites, patient recruitment engines, or both -Practical questions about feasibility, staffing, rural access, and patient trust -Along the way, we also chat about National Puzzle Day, curmudgeons, weird January weather, and the ongoing tech headaches of livestreaming this series. If you're interested in where clinical trials are headed, the future of site networks, and how retail healthcare players might reshape research access, this one's for you.

Are independent research sites slowly being squeezed out of existence—or is there more opportunity than ever? In this episode of Note to File, Brad and Denali sit down with Dan Sfera for a candid, unfiltered conversation about the real state of clinical research: consolidation, private equity, AI, site networks, and what it all means for the people actually running studies and caring for patients. From "when does being a site owner stop being fun?" to digital twins, AI, and the death of the generalist, we dig into the tension between scale, margins, and meaning in this industry. If you're a site owner, CRC, CRA, sponsor, or just clinical-research-curious, this one's for you.

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!

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.

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!

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.

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.

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.

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!

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."

This week, we dive headfirst into the holiday madness: the fine art of pretending things can wait till January, how stuffing a week's worth of chaos into three days is our new normal, and why Thanksgiving is synonymous with "eating a regrettable amount of food" (parades optional). But don't worry, we're not just here for turkey talk. We rip into site centricity (is it more than branding?), the never-ending sponsor/CRO shuffle, and why clinical research still can't figure out standardization to save its life. Private equity's creeping fingers? NIH funding's real impact? Fragmented systems that would drive anyone to drink? Yep, it's all in here. We even tackle the million-dollar question: is there a user-friendly, centralized home for finding trials? (Spoiler: "No.") Plus, anecdotes, Reddit gems, and a little healthy skepticism about the "synergies" of consolidation. Got thoughts, rants, or industry beef? Drop us a line at notetofilepodcast.com. Subscribe, listen, and join the conversation as we pull no punches and keep clinical research as weird - and real - as it deserves to be.

In this episode, we discuss the Abbott-Exact Sciences mega-acquisition, the nuanced world of CROs, challenges and opportunities in decentralized clinical trials (DCT), the explosive growth of clinical trial technology, and the real-world impact of NIH grant funding cuts. We also debate the ethics of drug availability in international trials and dig into site-centricity, innovation, and the ever-changing clinical research landscape. Also, Denali says "niche" wrong. Enjoy candid commentary, industry news, and some laughs along the way! Got feedback or want to be a guest? Reach out via LinkedIn or our anonymous form at notetofilepodcast.com.

In this episode: does AI really want your job, or is it just here for the snacks? Why does "communication" mean "good luck finding my phone number," and can the job market get any weirder (spoiler: yes)? Brad and Denali banter about the latest "new normal," classic tech headaches, and why public awareness still needs new batteries. You'll get poetry, wild tangents, a little outrage, and a lot of the good stuff they never put in the company newsletter

In this episode, Denali and Brad are joined by the ever-chill Steve Wimmer of 1nHealth for a wide-ranging, caffeine-fueled chat about everything from AI-powered patient recruitment to why running clinical trials sometimes feels like herding digital cats. We take you behind the scenes of recruitment campaigns, hash out whether AI is the solution or just a new sticker for your PowerPoint, and dig into why some sites treat digital ads like cryptic hieroglyphs. Along the way, you'll hear hot takes on industry best practices, cold weather in Orlando (spoiler: "frigid" means below 70°F), and the eternal struggle of getting patients to pick up the damn phone.

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.