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John Oncea

@buck25.bsky.social
39 followers 121 following 105 posts

I'll leave that to your imagination.

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John Oncea @buck25.bsky.social · 01/10/2026
AI governance is becoming a competitive edge in clinical research. Organizations need enough structure to adopt useful tools quickly, protect data, manage model risk, and keep humans accountable for consequential decisions. www.clinicaltechleader.com/doc/ai-gover...
clinicaltechleader.com
AI Governance Is Becoming A Competitive Edge In Trials
Strong data hygiene, formal governance, and human oversight are becoming essential to responsible, scalable AI adoption in clinical trials.
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John Oncea @buck25.bsky.social · 29/09/2026
A biostatistician's job isn't simply to analyze the trial after it ends; it starts before the trial begins, shaping the question, endpoints, population, data collection, estimand, and analysis plan. Faster reporting does not replace design-stage judgment. www.clinicaltechleader.com/doc/why-the-...
clinicaltechleader.com
Why The Biostatistician's Seat At The Table Keeps Vanishing
A Pfizer and Cytel veteran on why statisticians belong at trial design, and why fewer sponsors keep them in-house.
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John Oncea @buck25.bsky.social · 28/09/2026
A 73% trial-disclosure noncompliance rate became 2.4% in two years. The fix wasn't more reminders; it was infrastructure: clear ownership, standardized workflows, tracking, accountability, and time for change adoption. www.clinicaltechleader.com/doc/from-non...
clinicaltechleader.com
From 73% Noncompliant To 2.4%: Building A Compliance Office
How one research administrator cut a universitys clinical trial disclosure noncompliance from 73% to 2.4% in two years, then built a second office.
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John Oncea @buck25.bsky.social · 24/09/2026
AI's biggest benefit to clinical research may not be work automation. Rather, it may be surfacing enrollment, staffing & feasibility risks before a trial starts. This only works when built on clean data, tested against reality & reviewed by people. www.clinicaltechleader.com/doc/how-ai-i...
clinicaltechleader.com
How AI Is Used To Predict Trial Performance Before Enrollment
AI and early digital twin models can help forecast trial performance, refine site feasibility, and anticipate operational needs before enrollment begins.
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John Oncea @buck25.bsky.social · 22/09/2026
Phase 3 does not fix unanswered dose or population questions - it makes them much more expensive. A target product profile and early cross-functional input reduce uncertainty before it becomes a multi-million-dollar problem. www.clinicaltechleader.com/doc/two-plan...
clinicaltechleader.com
Two Planning Mistakes That Quietly Sink Clinical Programs
A veteran biostatistician on the planning document and the dose-selection shortcut that quietly decide whether trials succeed.
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John Oncea @buck25.bsky.social · 21/09/2026
Most clinical research technology failures are not software failures; they are readiness failures. If teams skip workflow design and move straight from “we have a problem” to implementation, the technology exposes the process gap. It does not solve it. www.clinicaltechleader.com/doc/a-framew...
clinicaltechleader.com
A Framework For Diagnosing Clinical Research Technology Maturity
A 30-year clinical research veteran breaks down the four stages of technology maturity and why most organizations misjudge their own.
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John Oncea @buck25.bsky.social · 17/09/2026
Stop me if you've heard this before: a routine screening visit required 12 systems and 29 separate steps. Clinical trial sites do not need more technology. They need systems that exchange data without making coordinators the integration layer. www.clinicaltechleader.com/doc/clinical...
clinicaltechleader.com
Clinical Trial Sites Don't Need More Tech, They Need Fewer Silos
Disconnected systems – not a lack of technology – are slowing clinical trial execution and forcing site staff to bridge costly workflow gaps.
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John Oncea @buck25.bsky.social · 15/09/2026
Digital twins can improve trial efficiency. Replacing a randomized control arm is a bigger claim. Randomization protects against unknown differences in patient response. A model must show it reduces that uncertainty, not predict around it. www.clinicaltechleader.com/doc/a-biosta...
clinicaltechleader.com
A Biostatistician's Caution Around Digital Twins In Trials
A veteran statistician explains why she’s unconvinced digital twins can replace randomization in clinical trials, at least for now.
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John Oncea @buck25.bsky.social · 14/09/2026
Data-quality problems do not begin when a database locks. They begin when protocols are signed without clear ownership of how data will be captured and validated. AI can flag issues. It cannot own the decision or accountability. www.clinicaltechleader.com/doc/who-owns...
clinicaltechleader.com
Who Owns Data Quality? The Authority Gap Slowing Trials
A former Bayer medical affairs lead explains why data-quality decisions land with whoever controls the budget, not whoever understands the data.
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John Oncea @buck25.bsky.social · 10/09/2026
Clinical research has a workforce problem: the U.S. does not formally recognize clinical research professionals as a distinct occupation, making it harder to measure the workforce, build pathways in, and grow the field beyond poaching its own talent. www.clinicaltechleader.com/doc/clinical...
clinicaltechleader.com
Clinical Research Isn't Even A Recognized Job. That's A Problem.
The U.S. doesn’t have an official job code for clinical research professionals. David Vulcano explains why that gap is holding back the workforce.
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John Oncea @buck25.bsky.social · 08/09/2026
RWE’s bottleneck is no longer data access. AI can surface patterns across EMRs, claims, registries & devices, but people still have to decide if a signal is real, meaningful & worth acting on. The unanswered question is: who has the capacity to ask why? www.clinicaltechleader.com/doc/the-data...
clinicaltechleader.com
The Data Was Already There: RWE's Real Bottleneck Is People
A pharma medical affairs veteran explains why real-world evidence’s biggest constraint isn’t data volume; it’s having enough people to interpret what AI finds.
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John Oncea @buck25.bsky.social · 03/09/2026
Trial sites are not burning out because of technology. They are burning out because the same data gets entered into multiple systems. The fix is not fewer tools. It is data entered once and shared where it needs to go. www.clinicaltechleader.com/doc/duplicat...
clinicaltechleader.com
Duplicate Tech, Not Technology, Is Burning Out Trial Sites
Clinical trial sites aren’t overwhelmed by technology – they’re overwhelmed by entering the same data into disconnected systems again and again.
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John Oncea @buck25.bsky.social · 27/08/2026
Clinical trial systems don’t fail to connect because the technology is missing. They fail to connect because openness costs money, switching is hard, and vendors lack incentive to make it easy. Interoperability is an economics problem. www.clinicaltechleader.com/doc/the-real...
clinicaltechleader.com
The Real Reason Clinical Trial Systems Don't Talk To Each Other
Clinical trial technology isn’t the barrier to interoperability; the economics are. Two industry leaders explain why nothing forces systems to connect.
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John Oncea @buck25.bsky.social · 24/08/2026
Before asking what AI a remote-monitoring platform uses, ask whether its data is trustworthy. How was the sensor validated? How is timing managed? What happens when packets are lost or Bluetooth disconnects? Vendor diligence starts before the dashboard. www.clinicaltechleader.com/doc/the-vend...
clinicaltechleader.com
The Vendor Questions Most Clinical Tech Buyers Forget To Ask
A practical checklist for evaluating decentralized trial technology vendors, built from an RF engineer’s view of where data quality actually breaks.
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John Oncea @buck25.bsky.social · 20/08/2026
Clinical research doesn’t need more AI promises. It needs proof. ACRP CEO David Vulcano argues that AI successes and failures should be shared with the same rigor we apply to clinical trial results. What worked? What failed? What did we learn? Read: www.clinicaltechleader.com/doc/ai-in-cl...
clinicaltechleader.com
AI In Clinical Trials: Stop Hyping It, Start Proving It
David Vulcano wants clinical research to report AI failures with the same rigor it applies to adverse events. Here’s why that call-to-action matters.
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John Oncea @buck25.bsky.social · 17/08/2026
AI can flag bad decentralized trial data. It cannot fix data that was bad before it arrived. Sensor placement, timing drift, packet loss, and poor connectivity all happen upstream of the model. The foundation still comes first. Learn more here: www.clinicaltechleader.com/doc/what-ai-...
clinicaltechleader.com
What AI Can't Fix In Decentralized Clinical Trial Data
An RF and semiconductor engineer explains why AI can’t compensate for hardware and connectivity errors, and what questions to ask instead.
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John Oncea @buck25.bsky.social · 13/08/2026
Decentralized trials reduce burden only when they replace something. A wearable that eliminates the need for a site visit helps. One added to an already packed protocol may create more work for patients. Before adding tech, ask: what does it replace? www.clinicaltechleader.com/doc/decentra...
clinicaltechleader.com
Decentralized Trials Promised Less Burden. Did They Deliver?
Wearables and other technology to facilitate decentralized trials were supposed to ease patient burden. Elisa Cascade explains why the results depend entirely on design.
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John Oncea @buck25.bsky.social · 10/08/2026
Connectivity in decentralized trials isn’t an IT checkbox; it’s a data integrity issue. A device can appear connected even as packet loss, interference, or battery-driven trade-offs quietly compromise the data it sends. www.clinicaltechleader.com/doc/wireless...
clinicaltechleader.com
Wireless Connectivity Is A Data Integrity Issue, Not IT
An RF engineer explains why packet loss, multipath interference, and battery tradeoffs are scientific validity issues, not IT problems.
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John Oncea @buck25.bsky.social · 06/08/2026
Most AI validation claims answer the wrong question. A single accuracy score doesn’t tell you how a model will perform in the real world. Clinical AI needs portability testing across populations, sites, and devices, not just a headline number. www.clinicaltechleader.com/doc/why-clin...
clinicaltechleader.com
Why Clinical AI Validation Needs Portability Testing Beyond A Single Accuracy Score
A peer-reviewed study on voice AI and depression screening shows why demographic portability testing matters before deploying clinical AI tools.
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John Oncea @buck25.bsky.social · 04/08/2026
Accurate sensors aren’t enough. If timestamps drift across devices, multi-sensor trial data becomes unreliable. Synchronization is a blind spot in decentralized trials. Data quality isn’t just about the signal. It’s about the signal and the time. www.clinicaltechleader.com/doc/the-sync...
clinicaltechleader.com
The Synchronization Problem Clinical Research Isn't Watching
Why timestamp drift between wearable sensors quietly undermines decentralized trial data, and why almost no one is asking about it.
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John Oncea @buck25.bsky.social · 30/07/2026
Ophthalmology trials are a stress test for clinical research tech. The data is image-heavy, workflows depend on reading centers, and some bottlenecks are staffing, not software. Generic platforms built around forms don’t translate well here. www.clinicaltechleader.com/doc/why-opht...
clinicaltechleader.com
Why Ophthalmology Trials Are Clinical Research's Toughest Tech Test
A three-year ophthalmology coordinator on imaging integration, independent reading centers, and the one staffing problem no scheduling software has solved yet.
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John Oncea @buck25.bsky.social · 27/07/2026
Most clinical trial tech conversations start with software. They probably shouldn’t. If the analog signal from a sensor is wrong, nothing downstream can fix it. Data quality starts at the point of measurement, not in the cloud. www.clinicaltechleader.com/doc/why-trus...
clinicaltechleader.com
Why Trustworthy Clinical Trial Data Starts As Analog, Not Digital
An RF engineer explains why sensor physics and analog design, not software, determine whether wearable trial data can be trusted.
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John Oncea @buck25.bsky.social · 23/07/2026
Clinical trial coordinators are still acting as the “human API” between disconnected systems. After years of digital investment, the issue isn’t the tools—it’s that they don’t work together. What’s one fix that would actually give time back to sites? www.clinicaltechleader.com/doc/why-clin...
clinicaltechleader.com
Why Clinical Trial Coordinators Are Still The Human API
A CRC who touches eight systems before lunch explains why clinical research’s biggest technology problem may be interoperability, not a lack of software.
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John Oncea @buck25.bsky.social · 18/07/2026
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John Oncea @buck25.bsky.social · 15/07/2026
Clinical trial tech rarely fails in the demo; it fails at the handoff and when patients can’t use it. If you watched your next eCOA from a patient’s couch instead of a sponsor’s dashboard, what would you change? www.clinicaltechleader.com/doc/designin... www.clinicaltechleader.com/doc/clinical...
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John Oncea @buck25.bsky.social · 10/07/2026
Versiti’s data doesn’t just power dashboards; it determines whether patients with rare blood types receive the right unit in time. What would it take for your “AI strategy” to be as grounded as Versiti’s? www.clinicaltechleader.com/doc/how-vers... www.clinicaltechleader.com/doc/inside-v...
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John Oncea @buck25.bsky.social · 02/07/2026
“Design with them, not just for them.” If your sites helped choose and test your trial tech — and were paid for that time — how different would their day-to-day burden look? www.clinicaltechleader.com/doc/site-tec...
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John Oncea @buck25.bsky.social · 30/06/2026
“Pay or pay.” Either sponsors invest upfront in reducing site burden, or they pay later in delayed enrollment and burned-out coordinators. Where are you currently underpaying on site burden and overpaying on recruitment pain? www.clinicaltechleader.com/doc/paying-s...
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John Oncea @buck25.bsky.social · 26/06/2026
An excerpt from @clinicaltechleader.bsky.social's Live, Managing The Tech Stack In Today's Trials, in which Joe Dustin answers a question about whether integration is a red herring and if the real cause of problematic tech stacks is a misuse of standards. www.clinicaltechleader.com/doc/why-stan...
Headshot of Joe Dustin, Founder & Principal, Dauntless eClinical Strategies, promoting his participation in the Clinical Tech Leader Live event, Managing The Tech Stack In Today's Trials. Specifically, a segment during which he explains why standards matter at scale.
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John Oncea @buck25.bsky.social · 24/06/2026
Joe Dustin explains why validation documentation and sponsor benefit are key to getting approval for site-system integration in this excerpt from the @clinicaltechleader.bsky.social virtual event, Managing The Tech Stack In Today's Trials. www.clinicaltechleader.com/doc/validati...
Headshot of Joe Dustin, Founder & Principal of Dauntless eClinical Strategies, positioning him as a panelist for the Clinical Tech Leader Live event "Managing The Tech In Today's Trials".
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John Oncea @buck25.bsky.social · 22/06/2026
We covered a lot of ground during our Live event, Managing The Tech Stack In Today's Trials, including why sponsors should stop guessing and ask sites what tech they use so teams can design with sites, not just for them: www.clinicaltechleader.com/doc/ask-site...
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Reposted by John Oncea
MLB Transaction Bot @transactionbot.bsky.social · 17/06/2026
Texas Rangers signed free agent LHP Benjamin DeTaeye to a minor league contract.
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John Oncea @buck25.bsky.social · 15/06/2026
Part 3: What actually works in clinical trial tech More tools don’t reduce burden - better integration, stronger protocols, and real alignment do. The best tech stack removes friction. Not adds to it. www.clinicaltechleader.com/doc/building...
clinicaltechleader.com
Building A Clinical Trial Tech Stack That Actually Works
The right clinical trial tech stack isn’t the most complete one; it’s the one built with sites, funded fairly, and designed to remove friction, not add it.
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John Oncea @buck25.bsky.social · 11/06/2026
It’s not about whether sites or sponsors have tech; it’s about what happens when both do. Who decides which systems stay? Who pays for integration? And what makes it worth it? Integration only works when it’s a shared business case, not a favor to sites. www.clinicaltechleader.com/doc/the-inte...
clinicaltechleader.com
The Integration Dilemma: Who Decides Which Tech Stack Wins?
Sponsors and sites both have technology, but integration only works when validation, economics, and site diversity are factored in from the start.
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John Oncea @buck25.bsky.social · 09/06/2026
Clinical trial sites aren’t resisting tech; they’re drowning in disconnected systems. In this article, I explore the real burden: manual workarounds, poor integration, and missed alignment with sites. Part 1 of a 3-part series: www.clinicaltechleader.com/doc/why-clin...
clinicaltechleader.com
Why Clinical Trial Sites Are Drowning In Tech Chaos
Sites aren’t resistant to technology; they’re buried under disconnected systems, delayed documents, and manual workarounds sponsors keep ignoring.
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John Oncea @buck25.bsky.social · 03/06/2026
Clinical trial tech should make studies easier to run, not harder. @clinicaltechleader.bsky.social Live’s Managing the Tech Stack in Today’s Trials looks at what it takes to build a stack that supports operations. View the discussion here: www.clinicaltechleader.com/doc/managing...
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John Oncea @buck25.bsky.social · 27/05/2026
The third installment in my three-part series on the FDA's RTCT pilot, in which I explain what hasn't changed, ask questions the industry hasn't answered & share what sponsors, CROs & sites should be doing to prepare for what's coming. Click for more: www.clinicaltechleader.com/doc/digital-...
clinicaltechleader.com
Digital Endpoints Are Ready. Clinical Development Isn't
Regulatory guidance and validation science for digital endpoints are solid. The real barrier is cross-functional execution – and the cost of waiting is compounding.
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John Oncea @buck25.bsky.social · 26/05/2026
If you're interested in the FDA's RTCT initiative, check out this look at what demands will be placed on your tech stack. TL/DR: If you want to be positioned for the pilot or broader adoption that follows, you're already behind if you haven't started. www.clinicaltechleader.com/doc/what-rea...
clinicaltechleader.com
What Real-Time Clinical Trials Demand From Your Tech Stack
RTCT requires continuous data flow, AI governance, and real-time coordination. Here’s what the infrastructure shift actually demands, and where the current industry falls short.
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Reposted by John Oncea
ISPOR @ispor.bsky.social · 20/05/2026
Check out highlights from #ISPORAnnual in Philadelphia! --> www.linkedin.com/feed/update/...
linkedin.com
#isporannual #heor #healthcare #healthpolicy #rwe #hta #marketaccess #patients | HEOR Conferences
It’s a wrap! ISPOR 2026 concluded today with a closing keynote, delivered by John G. Singer, Founder and Executive Director of Blue Spoon Consulting, that offered a perspective on the future of the he...
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John Oncea @buck25.bsky.social · 20/05/2026
RTCTs are an FDA pilot-phase modernization effort focused on structured signal sharing, not continuous raw-data surveillance, and not a replacement for existing regulatory review frameworks. Learn more about RTCTs, the FDA's goals, and what comes next. www.clinicaltechleader.com/doc/the-fda-...
Two researchers looking at a screen in front of them that displays an AI-powered genomic analysis
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John Oncea @buck25.bsky.social · 20/05/2026
Happy #CTD2026, and thank you for designing better studies, supporting sites and patients, and helping move research forward. But, do you know how #ClinicalTrialsDay came to be? Or how the technology you use is helping #ResearchRising? www.clinicaltechleader.com/doc/what-is-...
Clinical Trials Day 2026. Building trusted communities where clinical research professionals stay informed, solve challenges, and move work forward.
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John Oncea @buck25.bsky.social · 19/05/2026
looks like it ended well to me.
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John Oncea @buck25.bsky.social · 18/05/2026
"Across the industry, the digital transformation journey is both further along and further behind than anticipated." Victoria Gamerman, @boehringerglobal.bsky.social Find out why she feels this way and what genuine clinical trial digitization looks like: www.clinicaltechleader.com/doc/pharma-s...
A woman holding a digital tablet in her left hand while looking at and interacting with a projected screen with her right hand.
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John Oncea @buck25.bsky.social · 14/05/2026
When evaluating AI platforms, the question isn’t just “what does this tool do?” It’s “what does this tool require from our data architecture, and do we have it?” Those are different conversations, and the second determines if the first one ever pays off. www.clinicaltechleader.com/doc/how-ai-i...
clinicaltechleader.com
How AI Is Changing Clinical Trial Design, Not Just Speed
The real AI opportunity in clinical trials isn’t efficiency – it’s simulating better studies before enrollment begins.
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Reposted by John Oncea
Jade Van Kley @backlinenurse.bsky.social · 08/04/2026
this the shit I been up to
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John Oncea @buck25.bsky.social · 12/05/2026
Digital endpoints aren’t stalled by tech or regulation - they’re stalled by misalignment. Teams still aren’t aligning early enough, so they default to “safe” endpoints. It’s a coordination problem. www.clinicaltechleader.com/doc/dime-s-n...
clinicaltechleader.com
DiMe's Navigator: Why Teams Still Stall On Digital Endpoints
DiMe’s sDHT Adoption Navigator helps clinical teams move from guidance to action, but the real test is whether organizations use it early enough to matter.
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John Oncea @buck25.bsky.social · 11/05/2026
Digital endpoints are ready: FDA guidance, tech maturity & validation evidence. So why aren’t they in more pivotal trials? Hint: it’s organizational alignment. Clinical development doesn’t need more proof; it needs better coordination. www.clinicaltechleader.com/doc/digital-...
clinicaltechleader.com
Digital Endpoints Are Ready. Clinical Development Isn't
Regulatory guidance and validation science for digital endpoints are solid. The real barrier is cross-functional execution – and the cost of waiting is compounding.
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Reposted by John Oncea
Joe Posnanski @joeposnanski.com · 07/05/2026
Old Dogs.
open.substack.com
The Joy Series: Old Dogs
On Westley, sleep zones, and the love that comes with being chased
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John Oncea @buck25.bsky.social · 04/05/2026
If you’re cleaning data at the end of your trial, you’re already behind. ICH E6(R3) is pushing continuous, risk-based data cleaning with real-time validation where it matters most. Better analytics won’t fix bad data; you’ll just get wrong answers faster. www.clinicaltechleader.com/doc/why-clin...
A person using a laptop computer with a large map of the world being projected from the laptop.
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John Oncea @buck25.bsky.social · 04/05/2026
Clinical trials have more tech than ever, so why is site burden rising? Join @clinicaltechleader.bsky.social to explore the real issue: not innovation, but alignment. Featuring experts from Tufts CSDD, Keenova & Dauntless. Free to attend 👉 event.on24.com/wcc/r/531746...
Upcoming virtual event titled Managing the Tech Stack in Today's Trials, including images of the four participants: Beth Harper, Joe Dusting, Rosalie Filling, and John Oncea
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