Note to File: A Clinical Research Podcast

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.

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.