Note to File: A Clinical Research Podcast

Brad Hightower
  • 4.9 (29)
  • Management
  • Updated Biweekly

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. 16h ago

    Joe O'Rourke: Private Equity, Retail Pharmacies & The Future of Research Sites

    The retail pharmacy revolution in clinical trials didn't exactly go as advertised. So what actually happened inside Walgreens, and what does it mean for sites? In this episode of Note to File, Brad and Denali sit down with Joe O'Rourke to unpack the real story behind retail pharmacies in clinical research – what worked, what didn't, and why traditional sites are still carrying most of the load. We get into: -Joe's origin story – from metabolic research at Johns Hopkins to pharma services and sales -How he built an early digital recruitment engine that spent $2M on Facebook in 50 days -Why Walgreens entered (and stuck with) clinical trials despite brutal rumors and headlines -The BARDA head‑to‑head trial: Walgreens vs a traditional CRO on speed, quality, and scale -Where retail pharmacies actually make sense in clinical trials (and where they absolutely don't) -How private equity, giant P&Ls, and misaligned incentives shape whether these models survive The universal pain for research sites: -Slow study startup -3% overhead fights that drag for 4 months -Opaque feasibility and "prove you're a real site" bias -Why even big AMCs are losing money on research and leaving 7‑figures unbilled -The role of novel sites, standardization, and site networks in fixing startup and sustainability -A teaser for Part 2: Brad's "cornucopia" of IRB questions for Joe and WCG If you're running a site, working at a sponsor or CRO, or trying to figure out whether retail pharmacies are friend or foe, this episode will feel uncomfortably familiar.

  2. 1d ago

    WHO's New GCP Course, China Data Ban & FDA's AI Pilot

    National Tourism Day, a mystery virus on a cruise ship, WHO launches a free clinical trials course, Congress wants to ban China data, and FDA is piloting AI-enabled early phase trials. Light vibes, heavy implications. In this episode, Brad and Denali riff on how all of this actually hits sites, sponsors, and patients: In this episode we cover: WHO's new free, self-paced clinical trials course 4.5 hours, 9 themes (ethics, GCP, community engagement, operational feasibility, etc.) Is this just another GCP box-check… or something more practical for real-world sites? Pandemic preparedness & the latest cruise ship outbreak Person-to-person transmission, high fatality, and what this says about "the age of pandemics" How global standards and infrastructure (WHO, Warp Speed, etc.) either help… or fall apart House panel move to ban clinical data from China, Russia, Iran, North Korea Concerns about IP theft, ethics, and data quality vs. the real motive: geopolitics and money What happens to diversity, inclusion, and global enrollment if we shut out huge populations? FDA's push to speed R&D & the AI-enabled early phase trials pilot Mirroring Australia's clinical notification model Public comments on the AI pilot: signal vs. noise, and who's just selling their product Paradigm's role, direct-to-FDA data streaming, and whether oncology is the worst place to start Sites, CROs, and sponsors caught in the middle Are we actually making trials faster and more efficient, or just reshuffling paperwork? Why free, credible training matters for developing countries and new site staff If you care about site operations, GCP that actually means something, global data politics, AI in clinical trials, and how any of this reaches coordinators and patients, this one's for you.

  3. 2d 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.

  4. 3d 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?

  5. 6d 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

  6. Jul 16

    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.

  7. Jul 15

    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.

  8. Jul 14

    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

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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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