Note to File: A Clinical Research Podcast

Note to File gets extra spicy on this one. Brad and Denali riff on everything from wearables and brain health studies to the White House's new "Science: A New Golden Age" report and why U.S. clinical trials are still so painfully slow, expensive, and overburdened.   They dig into:   - Why consumer wearables like Oura and Whoop still aren't meaningfully integrated into most trials   - The gap between "we're in a new golden age of science" headlines and the on-the-ground reality at research sites   - The ethics and impact (or lack thereof) of sports-style betting on clinical trial outcomes via platforms like Kalshi   - The industry's obsession with collecting more data "just because," and how that plays out in bloated screening visits   - Brad's very real decision to move his site's source back to paper and what that says about the current state of eSource   If you care about site operations, U.S. trial competitiveness, the future of AI and wearables in research, or you're just here for the unfiltered clinical trials commentary and nonsense, this one's for you.

Clinical trial sites are leaking money, often without even realizing it. In this episode of Note to File, Denali and Brad sit down with Dr. Daniel Fox of CRPN (Clinical Research Payment Network) to unpack the ugly truth about site finances, brutal IWOs, "free" trial coaches, and why so many sites end up doing work for zero pay. From unscheduled visits that never get reimbursed to vague CTAs that sponsors happily reinterpret after startup, Daniel breaks down exactly where sites lose money, how to protect yourself, and what real leverage you have, whether you're a small independent site or part of a growing network. The conversation also hits Operation Trialblazer, collapsing trial phases, PE/VC money in research, and how site strategy shifts when your endgame is an exit versus a long-term community mission. Stick around to the end for Daniel's surprise: a clinical research negotiating board game designed to help sponsors, CROs, and sites see each other's incentives and turn budget pain into something a little more fun. Episode highlights: - Why most sites treat finance like a side job and pay for it later   - IWOs, "invoice it or lose it," and contracts that quietly erase your revenue   - The gap between contract negotiators and coordinators doing the actual work   - How specific language in your CTA can save you from post-award "reinterpretation"   - IRB fees, pass-throughs, and central IRBs that don't want to pay sites   - Trial coaches and CTEs: "free" support that eats your time and margins   - Operation Trialblazer and what single, bigger trials mean for sites   - PE and big site networks: chasing EBITDA versus serving patients and sponsors   - When to fail fast on a bad trial instead of grinding it out and wasting money   - Daniel's CRPN negotiating board game and how it brings site finance to life If you run or support a clinical trial site and have ever asked, "Where did all the money go?" this episode is for you.

What happens when DC policy, FDA buzzwords, and real-world site pain all collide? In this episode, Brad and Denali sit down with Anthony Corso, VP of Public Policy at Veeva, to unpack the chaos and opportunity in today's "clinical research renaissance." We dig into:   - Real-time clinical trials and the mysterious rise (and fizzle?) of the FDA's Trialblazer initiative   - Why "real-time" safety data is mostly a fantasy at the site level   - One-and-done Phase 3 trials, master protocols, and how complexity keeps getting pushed onto sites and patients   - The quiet policy moves around fair market value, participant stipends, and how trial income can cost people their benefits   - ONC, EHRs, and the dream (or nightmare) of auto-matching patients to clinicaltrials.gov   - Why e-consent and e-source still aren't standard, and how misaligned incentives keep innovation stuck   - The real-world impact of trials: from oncology patients gaining years of life to the grind sites face just to keep the lights on   If you care about where clinical trials are actually headed – beyond the press releases – this one gets into the messy middle: policy, tech, regulators, CROs, sites, and the patients caught in the system. New here? Note to File is independent, unfiltered commentary for the clinical research community. Subscribe for more conversations on trials, tech, sites, and the people trying to fix this industry from the inside.

From National Mac & Cheese Day to the broken economics of centralized recruitment… this Sticky Notes episode goes from nonsense to nuclear takes on how sites really handle patient recruitment. Denali and Brad dig into why so many sites are drowning in bad referrals, buried in tools, and still treating recruitment like a side quest instead of a core competency. They challenge the idea that sponsors and central vendors should own recruitment, and make the case that sites need to embrace what this really is: a sales process for motivated patients that can absolutely be done ethically. We get into:   – The reality of central campaigns, garbage referrals, and "anyone will click anything" ads   – Why sites complain about recruitment but won't invest dedicated people or time into it   – Site-owned tech vs sponsor tech sprawl (four logins just to pre-screen? really?)   – Personalized patient navigation: what it should actually look like at the site level   – How AI might help pre-screening… and where patients instantly check out   – The ethics of "selling" clinical trials without becoming a used car salesperson   – Why high-performing sites should get more of the recruitment budget and leads   Plus:   – A cash-pay surgery center in Oklahoma City that might be the perfect research partner   – Mac and cheese supremacy, Bastille Day, shark awareness, and why bugs are the enemy   – Why coordinators shouldn't be forced to moonlight as sales reps   If you run or work at a clinical research site, this one will either make you mad, motivated, or both.   Want more unfiltered conversations about clinical trial operations, sites, and industry nonsense?   Subscribe and check out notetofilepodcast.com for episodes, show notes, and more.

Clinical research sites are *quietly holding all the cards*—so why are they still struggling for support, fair budgets, and real partnership? In this episode of **Note to File**, Brad and Denali sit down with **Maria P. Ladd**, self-declared **Clinical Research Site Advocate** and co-founder of the **Clinical Research Site Collective**, to dig into the gap between sites, CROs, sponsors, and IRBs—and how we can finally start closing it. From **budget negotiations and profit margins** to **IRB relationships** and **site community-building**, this conversation hits the real, unfiltered pain points of running a research site in 2024 and beyond. --- In this episode, we get into: - Why Maria created the **Clinical Research Site Collective** and what "site advocacy" really means   - How sites can better **leverage IRBs** as a *resource*, not just a regulator   - The messy reality of **budget negotiations**, FMV, and why profit margin at sites should NOT be a dirty word   - How smaller and emerging sites can survive when studies keep getting more complex   - Whether we still need **local IRBs**—and what a "single IRB of record" world might look like   --- Who this is for: - Independent and emerging **clinical research sites**   - Site networks, AMCs, and research leaders   - CRAs, project managers, and sponsor/CRO folks who *actually* want to understand sites   - Anyone trying to build a more sustainable, collaborative clinical trial ecosystem   --- 🔗 **Connect with Maria**   LinkedIn: *Maria P. Ladd*   Clinical Research Site Collective: **clinicalresearchsitecollective.com** 🎧 More episodes & contact: **NoteToFilePodcast.com**