Explorez tous les épisodes du podcast 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.

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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  

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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**

In this episode of **Note to File**, Brad and Denali dig into:  

- **Why independent sites get boxed out** of imaging, colonoscopy suites, and other hospital-owned services  
- How **legal, IRB, compliance, and procurement** teams quietly kill otherwise great trials  
- The ugly reality of **Medicare coverage analysis**, double billing risk, and why millions go *unbilled* out of fear  
- The latest political push around **diversity in clinical trials** (and why the new rhetoric doesn't quite add up)  
- Whether decentralized trials and rural access actually solve the **diversity problem**—or just move it  
- A new multi‑agent **AI "virtual trial design team"** (informaticist, clinician, statistician, etc.) that could finally fix our worst protocols  
- Why **bad protocol design** is the real root cause behind "recruitment problems" and constant screen failures  

Mixed in: national "holidays," accidental **snail farming**, and a July lineup of guests from site collectives, payments, and tech.  

If you care about **independent sites**, **coverage analysis**, **DEI in trials**, and **where AI actually makes sense in clinical research**, this episode is for you.  

🔔 **Subscribe** for more unfiltered conversations about clinical trial operations, site life, and the future of research.  
🌐 More at **NoteToFilePodcast.com**

World UFO Day, disco, and…Operation *Trial* blazer?  

In this episode of **Note to File**, Brad and Denali kick things off with some classic nonsense—World UFO Day, Roswell, National Disco Day, and why U.S. soccer fandom magically appears every four years—before diving into a serious (and pretty spicy) breakdown of **clinical trial access, economics, and Operation Trailblazer**.

We unpack:  
- Why only **3–7% of oncology patients** ever make it into a trial—even though the majority say they *would* participate  
- How **economic and household realities** (time off work, travel, childcare, insurance coverage) quietly gatekeep trial participation  
- Why **oncology, IBD, chronic pain, and derm** behave very differently when it comes to trial incentives  
- The tension between **protocol design vs. real-world feasibility** and whether we're making research harder than it needs to be  
- What **Operation Trailblazer / "Trial Blazer"** actually is, who it's really built around (QRIs, AMCs, big systems), and what that means for **community sites and site networks**  
- Whether government is fixing **paperwork problems or patient problems**  
- EHR flags, master protocols, single pivotal trials, anti‑kickback safe harbors, and why **adoption** of existing guidance may matter more than any new initiative  
- The weird mix of **American exceptionalism, global competition, and budget cuts** that shape U.S. research policy

If you care about **site-level reality**, **patient access**, and how policy actually hits the ground (or doesn't), this one's for you.

**Timestamps (approx):**  
0:00 Cold open & intro  
3:20 World UFO Day, aliens, and deep-sea vs deep-space  
7:40 Made in the USA Day, World Cup, and U.S. soccer culture  
10:15 National Disco Day & Note to File playlist ideas  
11:55 Why so few oncology patients join clinical trials  
16:30 Insurance, community cancer centers, and structural barriers  
19:40 Are we making trials hard on purpose—or just badly?  
20:50 Operation Trailblazer / "Trial Blazer" overview  
23:10 Qualified Research Institutions (QRIs) & phase I focus  
24:45 Could community sites do this better than AMCs?  
27:00 EHR flags and why doctors mostly click past them  
29:45 Participant payments, undue influence, and safe harbor  
31:30 Single pivotal trials & what that means for sites  
33:30 Master protocols & not reinventing the wheel  
36:00 Policy, trust, and guidance no one follows  
39:00 Fourth of July disco playlist & outro

**Listen if you're into:**  
- Clinical trial operations & site strategy  
- Oncology and access to innovation  
- U.S. research policy & Operation Trailblazer  
- Real talk about what actually works at the site level

Is "innovation" in clinical trials just a cover for offshoring risk and cozy politics?  

In this episode of **Note to File**, Brad and Denali dive into two big stories shaping clinical research right now:  

1. **Congress vs Big Pharma in China**  
   - US House subcommittee letters to Merck, AbbVie, Lilly, Pfizer & more  
   - Early-phase trials in **Chinese military hospitals**  
   - Alleged **informed consent gaps** and **IP leakage** to the Chinese military  
   - Is this about **ethics & patient safety**, or **America-first politics** and control?  

2. **"Real-Time Trials" & the Paradigm Problem**  
   - What the hell is *"signal-level data"* actually supposed to mean?  
   - Why the FDA + Paradigm announcement felt like **ready, fire, aim**  
   - Venture capital, ex-government leadership, Operation Warp Speed ties  
   - Are we solving real problems, or just funding the best press releases?  

Along the way we also hit:  
- Work-life balance vs American grind culture (paternity leave, 4‑day work week)  
- National "holidays" for everything (Asteroid Day, Social Media Day… Note to File Day when?)  
- Clinical trials in **Minecraft** (yes, we went there)  

If you care about **where trials are really going**—who controls the data, who sets the rules, and who actually benefits—this one's for you.  

👉 **Subscribe** for more unfiltered, independent commentary on clinical trials, sites, and the messy reality behind the headlines.  
💬 Got thoughts on China trials or real-time trials? Drop them in the comments or hit us at **NoteToFilePodcast.com**.

Are we actually innovating in clinical research… or just slapping AI buzzwords on old problems?

In this episode of Note to File, we go deep on:

Founder-led vs board-appointed CEOs – why "benevolent dictators" might actually get more done
Why eccentric weirdos sometimes make the best leaders (and the worst coworkers)
The wave of AI-in-clinical-research announcements (Florence, EISF, "chat with your data," etc.) and why so much of it is just… AI slop
What sites REALLY need from AI:
Auto-filing ISF docs
Building source from protocols
Actual agentic labor, not just another chat box
CTMS vs QuickBooks – why finances at research sites are still a mess
The tension between running a research site like a business vs. not selling your soul to PE-backed growth-at-all-costs
The rise of small, independent sites and what's actually working for them
Along the way we detour through National Fudge Day, World Sea Turtle Day, and whether loving vegetables is a valid qualification for being CEO.

If you're a site owner, coordinator, sponsor, CRO, or tech vendor who's tired of hype and wants unfiltered, practical talk about the future of sites + AI, this one's for you.

👉 Subscribe for more independent, no-BS conversations about clinical research.
📬 Got a topic or rant? Hit us up at NoteToFilePodcast.com

Ever wondered how hard it really is to spin up a trial on ClinicalTrials.gov?

In this episode of Note to File, Brad and Denali walk through Brad's experiment:
he created and submitted a trial record on ClinicalTrials.gov just to see how far it would go. Spoiler: it got published… and the feedback was mostly about formatting, not scientific or ethical rigor.

We unpack:

🧾 How easy it is to create a ClinicalTrials.gov record using PRS
💻 Where AI "help" starts to blur the line between convenience and garbage data
🧪 What this means for patients who use ClinicalTrials.gov to find trials
🧨 How fake or low‑quality records could distort sponsor pipelines and vendor tools
⚖️ Recent cases of data falsification and fraud at research sites
🎰 A wild new angle: betting on clinical trial endpoints (Endpoint Arena)
What are people actually wagering on?
Could site staff or sponsors game the system?
Are we just importing sports-betting culture into clinical research?
Along the way we hit on:

The gap between what ClinicalTrials.gov was designed for vs. how patients actually use it
The tension between regulatory requirements, data integrity, and real-world behavior
How financial incentives, recruitment vendors, and "trial search" tools shape what patients ever see
If you care about trial transparency, site integrity, and the future of our ecosystem, this one's going to make you a little uncomfortable—in a good way.

🔗 Listen + subscribe:
Note to File podcast – unfiltered clinical research commentary, interviews, and general nonsense for the research community.

Have a topic you want us to dig into?
👉 Hit us up at NoteToFilePodcast.com

Clinical trial sites are drowning in double data entry, eSource chaos, and bad software that nobody actually wants to use.

In this episode of Note to File, Brad and Denali sit down with Oliver Keh, founder of Gleam, to talk about how his team is attacking data entry and QC from a site-first perspective—no forced sponsor rollout, no "move fast and break GCP" nonsense.

We get into:

Why data entry isn't a tech problem – it's a vendor + workflow problem
How Gleam does "fetch & fill" from any source to any EDC (without brittle APIs)
The reality of eSource vs paper and why going "back to paper" is not crazy
What FDA actually cares about with AI in clinical trials (fit-for-purpose + human in the loop)
Why most clinical trial tech fails: developers don't sit in sites
Usage-based pricing, weekly calls with coordinators, and building tools people actually use
If you're a site owner, coordinator, or sponsor who's tired of being sold garbage tech, this one's for you.

🔗 Connect with Oliver / Gleam

Website: joingleam.com

In this Sticky Notes episode, we riff on everything from clinical trial prediction markets (yes, literally betting on FDA approvals) to the murky world of seeding trials that look a lot more like marketing campaigns than science.

We dig into:

End Point Arena & trial prediction markets – paper trading today, real money tomorrow?
How investors already "bet" on trial outcomes by mining clinical data for stock picks
Seeding trials in phase 3/4: when "research" is really about drug exposure & provider behavior
The thin ethical line: are patients being misled when trials are primarily commercial tools?
IRB transparency (or lack thereof): what actually gets rejected, and who decides?
The blurry crossover between R&D and commercial, from branding during trials to MSLs as quasi-sales
Why most sites secretly need a sales & marketing mindset just to keep the doors open
Along the way, we also hit:

Conference season chaos
National Cheese Day, Hug Your Cat Day, and Moonshine Day
The ever-expanding definition of a "study coordinator"
If you're in sites, sponsors, CROs, or pharma and you've ever wondered, "Where does science end and sales begin?"—this one's for you.

👉 Have a topic you want us to tear apart next? Drop it at NoteToFilePodcast.com

Ever wondered what's REALLY happening with your pharmacy data, how EU sites operate compared to the U.S., or whether you actually need $1.5M to start a research site?

In this episode of Note to File, Brad and Denali go full sticky-note mode, bouncing from European work culture to GDPR smackdowns to the future of real‑world data and AI in clinical research.

In this episode, we dig into:
Copenhagen recap & EU site culture

Denali's trip to the Veeva R&D & Quality EU Summit in Copenhagen
Why EU sites feel more integrated with sponsors and health systems
The dominance of hospital- and health system–based sites vs. U.S. independents
Why true independent sites are rarer in Europe (overhead, infrastructure, and system design)
Four-day workweeks, efficiency & "wage slavery"

European 36-hour workweek norms in healthcare
Do four-day weeks actually maintain productivity?
Brad's reality check: embedded in clinics seeing patients 5 days a week
Efficiency vs. butts-in-seats: "Do great work, then go live your life."
IQVIA's GDPR fine & the illusion of anonymized data

Breakdown of the €5M GDPR fine tied to French health data warehouses
Pharmacy and EMR data used for real-world evidence and analytics
Why "anonymized" often… isn't
Lack of transparency, consent, and real opt-outs for patients
How this parallels U.S. pharmacy data being used for recruitment and targeting
Consent, terms of use & contract fatigue

Are we really "consenting" when we click through IRB portals, pharmacy forms, and app updates?
Contract fatigue in modern life: signing everything, reading nothing
Data breaches, token identity monitoring, and what your data is apparently "worth"
Site startup myths & market trends

The myth that you need $1.5M to open a site vs. Brad's "a few thousand and some hustle"
Summer slowdown vs. pickup in site activity, PSVs, and study awards
How the current U.S. administration and policy uncertainty ripple through the pipeline
Real-world data, AI, IPOs, and whether anyone actually knows what they're building
All of this wrapped in the usual unfiltered, slightly chaotic, no-agenda Note to File energy—with shoutouts, side quests, and a friendly "podcast war" declaration with Steve Wimmer's new show.

In this episode of Note to File, Brad catches up with Denali live from Copenhagen as she kicks off the Veeva EU Summit—their first year meaningfully bringing sites into the mix.

They dig into:

-How the EU site landscape really compares to the US
-Whether sites and sponsors are actually more collaborative in Europe
-Why M&A and site networks look different across the pond
-And the big one: what airline interoperability and air traffic control can teach clinical research about standards, data exchange, and real-time oversight

Denali walks through her travel saga—from Delta to SAS to FlightAware—as a perfect analogy for how clinical trial tech breaks down the moment systems stop "speaking the same language." Brad and Denali explore why we still don't have:

-A "TSA / air traffic control" equivalent for clinical trials
-Minimal, shared standards for how data moves between sites, sponsors, and vendors
-Real incentives to play the long game ("one marshmallow now vs. five later") on interoperability

They also touch on:

-GDPR and EU data laws vs. US incentives
-What "meaningful use" did for healthcare data—and whether trials need their own version
-Why standardizing how data is transmitted (not the IP itself) could finally unlock speed and efficiency for everyone

And, of course, it wouldn't be Note to File without a little nonsense:

-Opening a Lisbon site
-Traveling as an American right now
-And the pitch for Steve Wimmer's fractional marshmallow MLM

If you care about site–sponsor relationships, global site networks, or why clinical trials still can't talk to each other in 2026, this one's for you.

Clinical trials are supposed to be science… but are they really?

In this episode of Note to File, Denali and Brad riff on everything from Veeva's EU R&D Summit in Denmark to patient recruitment reality vs. industry fantasy, and end up in a pretty honest place:

We're designing protocols for patients who don't exist.

We dig into:

-Veeva EU R&D Summit & "site day zero"
-Site–sponsor collaboration in the EU
-The chaos of regulations, cultures, and data sovereignty across a whole continent
-AI, agents, and site efficiency
-Auto‑filing IRB approvals into the ISF/TMF
-Schedule builders from the protocol
-eSource–EDC connectivity so sites never log into EDC again (in theory…)
-Patient recruitment reality
-Why mining clinic EHRs can feel creepy and low‑yield
-Advertising vs. "trusted doctor referral"
-Why Facebook ads can deliver more motivated patients than the clinic database
-The unicorn protocol problem
-Writing inclusion/exclusion for "perfect" patients just to get a clean signal
-Migraine studies where BMI cutoffs exclude the real‑world population
-Ethical questions: are we testing drugs on the people who will actually use them?
-Are clinical trials even good science?
-Lack of reproducibility across sites
-Wild variation in source docs and workflows
-The tension between "clean science" and messy real‑world practice

Along the way we also hit:

-Clinical Trials Day and the tidal wave of self‑congratulatory LinkedIn posts
-Why Brad is warming up to advertising despite his embedded‑site roots
-How site economics punish all the pre‑screening that doesn't enroll
-Motivations for participation: altruism, access to care, and "I just trust my doctor"

If you care about site operations, protocol design, and whether we're actually doing good science, this one's for you.

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.

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.

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.

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?

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

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.

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.

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

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.

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).

Today on  Note to File, we riff on everything from **Air Max Day** to the very real challenges facing clinical trial sites in 2026.

We start light with sneaker talk and "national days," then dive into three meaty topics for the clinical research community:

1. **The Ethics & Psychology of Trial Acronyms**  
   - Are names like **HERCULES**, **IRONMAN**, or **CINDERELLA** harmless branding or subtle false promises?  
   - How mythological or aspirational names can shape **patient expectations**, hope, and decision‑making.  
   - Why ultra-generic names like "SUMMIT" or cryptic codes like *D6‑75309‑0001* both cause headaches for sites, sponsors, and indexing.

2. **Branding Clinical Trials vs. Actually Recruiting Patients**  
   - The difference between **drug branding** (post‑market) and **trial advertising** (short‑lived, action‑oriented).  
   - Why patients don't care about the "Cinderella Trial" – they care about **their pain, their disease, and their options**.  
   - How segmenting your audience and tailoring creative (rather than forcing one unified "brand") can drive better recruitment and diversity.  
   - Real‑world example: why ads showing **real pain and limitation** outperformed "happy, active" imagery for phantom limb pain trials.

3. **Site Staffing: Slightly Better, Still Rough**  
   - Why site org charts are usually **flat**, with limited traditional "career ladder" for coordinators.  
   - The ongoing tension between **sites vs. CRO/CRA roles**: more money and prestige vs. travel, burnout, and less flexibility.  
   - How **culture, flexibility, learning opportunities, and fair pay** can keep great staff at sites.  
   - Ideas for giving coordinators **growth without fake titles**: exposure to budgets, BD, regulatory, data, and operations.

Along the way, we talk about:  

- Equal Pay Day and how **structural disparities** show up in research careers  
- The impact of **remote monitoring** on CRA life  
- Why "butts in seats 8–5" is a terrible proxy for productivity  
- How sites can lean into their strengths to become **great places to build a career**, not just a stepping stone

If you're a **site owner, coordinator, CRA, sponsor, or vendor** trying to navigate recruitment, staffing, and branding in real life (not in pitch decks), this one's for you. 

**Subscribe** for more candid, unfiltered conversations about the clinical research industry, and check out more at **notetofilepodcast.com**.

It's March 24th and we're back with another **Sticky Notes** edition of **Note to File: A Clinical Research Podcast**—where we mix serious industry topics with just the right amount of nonsense.

In this episode, we cover:

- 🥩 **National Cheesesteak Day** (plus cocktails, "National Stephanie Day," and the strangely titled *International Day for the Right to the Truth…*)  
- 💊 **National Adverse Drug Event Awareness Day** – why women are disproportionately affected, and how trial design and dosing play a role  
- 🧩 **ICON + Advarra's "research-ready, connected site network"** – is this actually helping sites, or just more sponsor/CRO-controlled tech dumped on them?  
- 📊 **Who owns your site data?** We dig into how IRBs and vendors may be using operational data for site selection and "intelligence"  
- 🧪 **Dana-Farber's $15M NIH settlement** over manipulated images – what this says about accountability in academic research  
- 💼 **New study on "corporate bullshit"** – why people who see through buzzwords and jargon may actually be *better* at their jobs (and why Kool-Aid drinkers might be happier)

If you work at a site, sponsor, CRO, IRB, or anywhere in the clinical trial ecosystem—and you're tired of sanitized, corporate-approved narratives—this one's for you.

---

### 🔖 Suggested Timestamps
0:00 – Cold open  
2:13 – Welcome to Note to File  
2:41 – Spring, spring break, and weather nonsense  
4:09 – National Cheesesteak Day & the "day of the day" rundown  
6:29 – National Adverse Drug Event Awareness Day (and gender differences)  
9:12 – ICON + Advarra "research-ready" network – what does this really mean for sites?  
12:06 – Are vendors mining site data for sponsors? Data ownership & ethics  
17:52 – Dana-Farber $15M NIH settlement over manipulated data  
22:02 – Study: corporate bullshit, buzzwords, and job performance  
25:10 – Kool-Aid, happiness, and critical thinking at work  
26:31 – Wrap-up

---

**About Note to File**  
Note to File is a clinical research podcast featuring interviews, candid commentary, and general nonsense for the clinical research community. No corporate spin, no paid messaging—just real talk from people in the trenches.

🌐 More at: **notetofilepodcast.com**  

---

#ClinicalResearch #ClinicalTrials #ResearchSites #Advarra #ICON #NIH #DanaFarber #Pharma #CRAlife #NoteToFile #HealthcareData #WorkCulture

Ever feel like life – and clinical research – are both a little chaotic and unpredictable… kind of like March weather and tornado season in Oklahoma?

In this **Sticky Notes** episode of **Note to File**, Brad and Denali kick things off with some real-life banter:  
- Spring break in **Oklahoma City**  
- Unseasonably **90-degree** days  
- The joy and dread of **tornado-adjacent season**  
- How March and April always seem like a weather "crap shoot"  

From there, we pivot back into the spirit of Note to File: candid, unscripted conversation for the **clinical research community**. If you're a CRC, coordinator, site owner, CRA, or just clinical-research-curious, this is your space to hang out, unwind, and still feel connected to the work.

🔹 **What you can expect from Sticky Notes episodes:**
- Short, informal check-ins between full episodes  
- Real talk about life *around* clinical research  
- The same unfiltered, practical vibe you know from Note to File  

---

📌 **About Note to File**  
**Note to File** is a clinical research podcast featuring interviews, commentary, and plenty of unscripted nonsense for people who live and work in the world of trials.

👉 More episodes, resources, and info:  
[https://notetofilepodcast.com](https://notetofilepodcast.com)

---

👍 If you enjoy this episode:
- **Like** the video to support the channel  
- **Subscribe** for more clinical research conversations  
- **Comment** where you're listening from and what your weather's like today

#ClinicalResearch #NoteToFile #StickyNotes #ClinicalTrials #ResearchSites #CRCs

Are we turning "clinically proven" into just another marketing buzzword?

In this Sticky Notes live episode, Denali and Brad dive into how the public encounters *clinical trials* not through journals or regulators, but through mushroom coffee emails, peptide ads, and GLP‑1 hype on social media. From biohacking with gray‑market peptides to the underrepresentation of women in research, this conversation pulls back the curtain on how science, perception, and marketing collide.

🧪 **In this episode we cover:**
- **National Doctor–Patient Trust Day & St. Patrick's Day:**  
  Lighthearted banter about trust in medicine, drunk crowds, and corned beef vs. Taco Tuesday.
- **Mushroom Coffee & "Clinically Proven" Marketing:**  
  An 8‑week "randomized clinical study" in a marketing email: what does that really mean?  
  Who's running these trials, where's the FDA, and how much should we trust claims like "clinically tested"?
- **Vitamin B12, GLP‑1s, and Safety Trade‑offs:**  
  Emerging concerns about impurities and interactions in GLP‑1 compounding.  
  How fast is *too* fast when it comes to development, approval, and post‑market surprises?
- **Peptides, Biohacking & the Gray Market:**  
  Ordering research‑grade peptides and GLP‑1 analogs straight from overseas.  
  N=1 "self‑experiments," influencer before/after pics, and where personal autonomy meets real safety risk.
- **Why Women Are Underrepresented in Trials:**  
  A study showing women are 51% of the population but only ~41% of trial participants.  
  Logistics, fear, eligibility criteria, and how trial design and history stack the deck.  
  Would men give the same reasons for *not* joining a trial?

🎧 **Who this episode is for:**
- Clinical research professionals who want an honest, unfiltered take on how the public actually sees trials  
- Sponsors, sites, and CROs thinking about trust, recruitment, and representation  
- Anyone tempted by "clinically proven" supplements, peptides, or weight‑loss injections  
- Curious listeners who like candid, sometimes irreverent conversations about medicine and research

---

🔔 **Subscribe** to Note to File for more independent, unfiltered conversations about the clinical trial industry.  
💬 Have a topic you'd like us to tackle next? Drop it in the comments or reach out at **notetofilepodcast.com**.

From raccoons with thumbs to $3.5B drug factories, this Sticky Note goes from absurd to deadly serious pretty fast.

In this episode, we dig into three big themes shaping the future of clinical research:

1. Lilly's $3.5B U.S. Manufacturing Bet

New mega‑facility in Pennsylvania and three more planned in the U.S.
How policy, tariffs, and incentives are pulling drug manufacturing back onshore
What this means for historically industrial regions that lost manufacturing jobs

2. China's Clinical Trial Explosion

China now accounts for ~30% of global clinical trials
Trials reported as 50–60% cheaper and 60–70% faster than in the U.S.
Regulatory shifts, trial infrastructure, and why the U.S. may get left behind on the "science" side while focusing on manufacturing

3. The Hard Reality of Community Oncology Research

Why oncology trials in community settings are so hard to run
Inclusion/exclusion challenges, timing of care, and tiny eligible populations
Financial reality for IROs/site networks vs. the clear ethical need for community oncology trials
Plus:

Burnout in clinical research and why it's under‑recognized at the site level
SOS Conference in San Diego, what to expect, and why the vibe matters

A brief detour into exotic pets, tarantulas, and weaponized raccoons (you've been warned)
If you care about where trials get run, who gets access, and how policy quietly reshapes our entire ecosystem, this one's for you.

In this episode of Sticky Notes, Brad and Denali debrief from the VIVE conference in LA, where they discovered just how little most health systems, CIOs, and IT vendors really understand about clinical research. From translating basic terms like CTMS and CRC into plain language, to explaining why research even matters to hospitals and health plans, we dig into the massive awareness gap between care delivery and clinical trials.

We also get into:

-Why research divisions inside hospitals are often ignored or siloed
-How vendor messaging has to completely change when talking to health systems
-The rise of real-world data (RWD), claims data, and EHR data in regulatory decisions
-New FDA guidance on Bayesian statistics and using historical data
-The shift toward one pivotal trial and what that could mean for sites, CROs, and sponsors
-Whether we're trying everything except just running better randomized clinical trials
-How conference culture is changing – from hard-sell BD apps to real community (looking at you, Save Our Sites)

Plus, in true Sticky Notes fashion, there's some talk about National Pistachio Day, renting guitars to shred at conferences, and why pistachios look weird but still slap.

In this episode of Note to File, Denali and Brad sit down with Dr. Brad Hall, founder of Senge, a boutique CRO focused on investigator-initiated trials (IITs) in eye care. They break down how independent clinicians can turn real-world questions from daily practice into publishable clinical research.

In this conversation, we cover:

-Why most IITs in eye care actually happen in private practice, not academia
-The biggest barriers independent clinics face (time, staff, IRB, budget)
-How to start with retrospective studies and build toward prospective IITs
-Funding options and how to partner with industry for real-world data
-Practical pros and cons of paper vs. EDC for small IITs
-Dr. Hall's LENS system from his book Idea to Impact:
-Launch with focus – defining the question, protocol, and consent
-Enroll with confidence – recruiting and retaining patients
-Notice the insights – collecting clean data and analyzing it
-Share the results – publishing and presenting your work

If you're an eye care provider (or any specialist) who's ever thought,

"I see this pattern in my patients—could I turn this into a study?"
this episode will show you what it actually takes to go from idea to impact.

-Are CROs "necessary evil" partners or overhyped money machines — and what does ICON's 50% stock plunge really tell us about the state of clinical research?

In this Sticky Notes episode of Note to File, we riff on everything from conferences and culture to credibility and regulation in our industry, including:

-ICON's revenue overstatement and the brutal market reaction
-What a 2% revenue error really means for trust, transparency, and CRO credibility
-The strange love/hate dynamic around CROs on LinkedIn, Reddit, and in the trenches
-How health system execs still don't really "get" research — and why that matters
-The massive gap between research professionals and healthcare executives at conferences like VIVE and Scope
-Whether the FDA could streamline oversight for low-risk trials without new legislation
-Why risk-based monitoring and "common sense" regulation still haven't truly shown up at the site level
-The paradox of an industry that bets billions on long-shot drugs but is terrified of operational innovation
-Sponsors as the real power center: why nothing changes until sponsors want it to

If you're a site, sponsor, CRO, or just a research nerd trying to make sense of where this industry is headed, this one's for you.

Live from SCOPE in Orlando, we're talking honestly about the clinical research conference circuit—what works, what doesn't, and why it all feels a little… exhausting.

In this episode of Note to File, we cover:

-What it's really like navigating a 5,000‑person conference with 200+ vendors
-Why every year we hear the same challenges in clinical research, over and over
-How the AI hype is shifting from marketing buzzwords to actual use cases
-The strange "conference economy" (big booths, big spends, but are we solving real problems?)
-Why more sites are showing up at SCOPE—and how they're using it for BD
-The pros and cons of massive conferences vs. smaller, content‑driven meetings

Along the way, we talk:

-Tattoo booths and disappearing egg rolls
-The grind of back‑to‑back conferences
-What hosting our own conference (SOS) taught us about how events should work for sites, sponsors, and CROs.

If you work in clinical operations, at a site, sponsor, or CRO, this is a candid look at what these conferences are actually doing for the industry—and what they're not.

In this Sticky Notes episode of the Note to File podcast, Brad and Denali dig into Walmart's new partnership with Care Access to launch clinical research sites inside shuttered Walmart health clinics.

We talk about:

-Why Walmart is re-entering clinical research now
-How shuttered retail clinics are being repurposed as research sites
-The broader story of retail pharmacies (Walmart, Walgreens, CVS, Kroger) jumping into — and out of — clinical trials
-The role of government research grants and public–private partnerships
-Whether retail giants should really be acting as research sites, patient recruitment engines, or both
-Practical questions about feasibility, staffing, rural access, and patient trust
-Along the way, we also chat about National Puzzle Day, curmudgeons, weird January weather, and the ongoing tech headaches of livestreaming this series.

If you're interested in where clinical trials are headed, the future of site networks, and how retail healthcare players might reshape research access, this one's for you.

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.

Get ready for a flavorful kickoff to 2026 with the latest Note to File podcast! 🎙️

In this episode, Denali and Brad serve up laughter and insight—from opening with comedic banter and cheese puns (did you know it's National Cheese Lovers Day?) to swapping stories about their favorite cheeses and regional cheese culture. But that's just the appetizer! Dive into the latest trends from the JPM conference, including industry updates, M&A highlights (or the lack thereof), and debates on the real significance of company announcements in clinical research. The hosts weigh in on the rising role of AI—like Anthropic's Claude—in trial design, recruiting, and regulatory submissions, and raise thought-provoking questions about using AI with imperfect clinical data.

The discussion gets real as they tackle the ethics of government-funded vaccine studies and the challenges of conducting clinical research in vulnerable populations. Plus, stick around for info on upcoming conferences, meetups, and the possibility of a live podcast stream from SCOPE!

Whether you're a cheese connoisseur or a clinical trials pro, this episode has something for everyone. Don't forget to like, comment, and subscribe for more unfiltered coverage of the world of clinical research!

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.