Note to File: A Clinical Research Podcast

Brad Hightower
  • 0.0 (0)
  • Management
  • Every two weeks

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. 8 hr ago

    Over 50% of Sites Are STILL on Paper?!

    Are we seriously still building source from scratch in 2025? In this episode of Note to File, Denali and Brad break down a new Tufts / CRIO paper on how sites actually prepare source and CRFs—and what the data really says about "innovation" in clinical trials. We get into the uncomfortable truth: -54% of sites are still using paper for visit source -Only 16% are using EMR/EHR to capture research data -Sponsors talk about real-time clinical trials, interoperability, AI, while sites are still living in Word docs, PDFs, and binders In this episode, we cover: -Why sites are forced to DIY source from protocol + CRF guidelines -The 6‑week lag to get critical docs from sponsors -How siloed CRO / sponsor teams make everything worse -Paper vs eSource: where electronic actually helps—and where it doesn't -Why "site-centric tech" is often just site-owned tech, not site-valuable tech -Where CTMS, finance, and eReg really do move the needle for sites -What has to change for sponsors and sites to both win If you run or work at a site, this is a reality check on where tech actually helps—and where paper is still winning by default.

  2. 1 day ago

    Real-Time Clinical Trials: FDA's Big Bet or Big Mess?

    The FDA just announced a bold push for real‑time clinical trials (RTCT) — including proof‑of‑concept studies, a new pilot program, and an RFI on AI-enabled tech to speed up decision‑making. But from the site and operations side, does any of this actually solve the real problems? In this Note to File episode, Denali and Brad dig into: What the FDA actually said in the recent RTCT press conference -The claim of "45% dead time" in trials – and what's really happening between last patient visit and submission -Why data streaming to FDA in real time raises huge questions about -Unclean / unadjudicated data -Unblinding risks -Sponsor exposure and control -How vendors like Paradigm and eSource / EHR data streams are being positioned as the tech backbone -Whether AI + interoperability can actually reduce timelines vs. just create new buzzwords -The disconnect between patient recruitment as the true bottleneck and this focus on data plumbing -Local vs. central IRBs, FDA commentary on IRB "modernization," and what that means for communities and oversight -Why so many people are clapping on LinkedIn while the details remain incredibly vague This is a skeptical but fair breakdown from the site-level trenches: What could RTCT get right? Where is it wildly underbaked? And what should sites, sponsors, and vendors be watching closely as the RFI window closes and the pilot program takes shape?

  3. 4 days ago

    Can Retail Pharmacies Save Clinical Trials? Walgreens, CVS, Kroger & Reality

    Walgreens is (maybe) pulling back from clinical research. CVS already bailed. Walmart and Kroger dabbled and went quiet. So what happened to the big retail pharmacy clinical trials dream—and what does it say about the future of sites and PE-backed networks? In this episode of Note to File: The Clinical Research Podcast, Denali and Brad dig into the rumors around Walgreens' clinical trial business, the earlier exits from CVS, Walmart, and Kroger, and why running trials out of retail pharmacies is a lot harder—and less lucrative—than the pitch decks made it sound. We get into: Retail pharmacies in clinical trials Why CVS launched hard and then shut it down What Walgreens actually did well (BARDA grant, active protocols, infrastructure) Why "successful trials" still may not hit Walgreens-level margins Could Walgreens have pivoted to become a recruitment vendor instead of a full site? Margins, PE, and the "this looked good in Excel" problem How clinical research looks like green space until you try to run a site Why even tens of millions in trial revenue can be a rounding error for mega-corporations What this might signal for private equity–backed site networks and consolidation Staffing reality at sites and retail pharmacies Pharmacists, techs, CRCs: burnout, turnover, and unrealistic expectations The gap between "we need people" and "we can actually hire and keep them" Why personality, adaptability, and breadth of experience beat narrow roles Vendor visits & understanding real site operations Why Brad wants more vendors to get out of the conference room and into sites How wildly different site workflows kill any idea of a "standard site" Why you can't design site tech from a closet and expect it to work LinkedIn, networking, and experience The weird over-indexing of clinical research on LinkedIn Using conversations, mentorship, and communities to shortcut the learning curve Why there's no hack for experience—but talking to more people is the closest thing If you've ever wondered why Walgreens, CVS, and other retail giants keep stepping into—and then out of—the clinical trial space, or what that means for independent sites, PE rollups, and patient access, this one's for you

  4. 5 days ago

    Interoperability, Incentives & Illusions of Progress in Clinical Trials

    Brad and Denali dive into the messy middle of clinical research tech – where sponsors, vendors, and sites all say they care about user experience and data quality, but nobody really owns the fallout. In this episode, we unpack: -The EDC email from hell: cryptic protocol strings, confusing log-ins, and why sites are constantly asking, "What study is this again?" -How sponsor configuration can make great platforms (Rave, Veeva, etc.) look terrible at the site level -The blame game between vendors, sponsors, and sites when UX goes sideways -The ongoing war: paper vs eSource vs hybrid for small and mid-sized sites -Why interoperability and remote monitoring sound awesome on paper but rarely show up in the budget -What we actually learned (and didn't) from the EHR revolution in healthcare -Why sponsors still don't care if you're on paper—as long as they get patients and data If you're a site, vendor, or sponsor who thinks you "own" user experience…this one might sting a little.

  5. 6 days ago

    Big Paper Wins Again? Sites, eSource, & the Standardization Problem

    Clinical research is out here discovering cutting‑edge therapies… and still arguing about paper vs. electronic systems. Make it make sense. In this episode of Note to File, Denali and Brad get real about why so many sites are still on paper in 2026, what tech vendors get wrong, and why standardization across sponsors, sites, and systems feels like a fantasy. We cover: -Why small and mid‑size sites often don't benefit from going fully electronic -The hidden costs and risk that eSource, eConsent, and CTMS can create for sites -Continuous remote monitoring vs. old‑school, 2‑day on‑site visits -How misaligned incentives between sites, sponsors, and vendors keep us stuck -What other regulated industries (airlines, banking) figured out that we haven't -Whether standardization needs to be driven by regulators, foundations, or "big players" -And, yes, why "Big Paper" might secretly still be winning We also warm things up with: -National Documentary Day, Eggs Benedict Day, and Wear Your Pajamas to Work Day -True crime and must‑watch documentary recommendations -Tax day, LinkedIn humblebrags, and layoffs in the research world If you work at a site, sponsor, CRO, or tech vendor, this one will probably hurt a little… in a good way.

  6. 14 Jul

    Drowning in data, starving for budget

    In this episode of Note to File, Brad and Denali dig into the messy realities of modern clinical research operations: The growing disconnect between cancer center administration and clinical operations How siloed academic structures make research less efficient (and more frustrating) Sponsors asking for constant E‑source access and screenshots (!?) The coming wave of continuous data streams (EHR, eSource, ePRO, wearables) and what that means for site workload Why the complexity of clinical trials is a feature, not a bug—and why sites should be paid accordingly EPRO in the real world: who's actually watching the data, and what do patients think is happening? Budgets, holdbacks, renegotiations, and the misaligned incentives between sites, CROs, and sponsors If you work at a site, sponsor, or CRO and feel like expectations keep going up while budgets stay flat, this one's for you. 👉 Subscribe for more unfiltered conversations about clinical research, from people actually doing the work

  7. 13 Jul

    Beer, Bots & Bad Interoperability

    National Beer Day, World Health Day… and AI chatbots pre‑screening your patients? In this episode of Note to File, Brad and Denali go from French‑Canadian prog rock and sneaker culture to some very real questions about how AI is creeping into clinical trials. We riff on: 🍺 National Beer Day vs. World Health Day – irony much? 🎸 A bizarre French‑Canadian prog rock duo with masks and microtonal guitars 👟 Sneaker talk: Shattered Backboards and why you should wear your shoes 🤖 AI chatbots in clinical research – IRB oversight, pre‑screening vs. screening, consent, and what can go wrong 🧠 AI tools for sites: pre‑screening, CRC "copilots," data entry helpers, and why interoperability is more politics than tech 🧪 Our plan to live‑test clinical trial AI chatbots on a future episode If you care about clinical trials, work at a site, or just like unfiltered conversation about where this industry is headed (with a side of music and shoes), this one's for you. 🔔 Subscribe for more independent, no‑BS conversations about clinical research. 💬 Got an AI chatbot you want us to test on air? Drop it in the comments.

  8. 10 Jul

    Who owns eSource?

    Are research sites doing everything twice for no good reason? In this Sticky Notes episode, Denali and Brad get real about eSource, EDC, and who should actually own site-facing tech. They move past the buzzwords and tackle the uncomfortable questions: Why is sponsor tech so fragmented for sites? If we're already entering everything into EDC, why do we still need separate source? Why isn't direct data capture the default? What do regulations and audit trails really require from sites? Are sponsors truly becoming "site-centric", or just saying that on stage at conferences? They also hit on duplicate data entry, interoperability, private equity–backed sites, and how real-life clinic workflows clash with sponsor systems. If you run or work at a research site—and you're tired of logging into 10 portals per study—this conversation is for you. 🔔 Subscribe for more blunt, practical discussions on clinical trial operations, site life, and research tech that actually works (or doesn't).

See All (100)

About

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.

Information

You Might Also Like