Note to File: A Clinical Research Podcast

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.

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.

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 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.

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."

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, 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.

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.