NexTrial

05/03/2026

I have been thinking a lot about a question that does not get asked in public enough.

🔍 An inspector walks into a clinical trial site. She picks a patient at random and asks the doctor, "Walk me through how you decided this patient was eligible for this trial."

That is the question every regulatory inspection in the world starts with.
If the doctor cannot answer it, source data, eligibility check, the logic that connected them, that is a finding. It can shut down enrollment. It can disqualify the data. It can end a career.

Now imagine an AI system made that eligibility decision.

The AI vendor shows the inspector a number. 94 percent confident.

That is not an answer. That is a marketing slide.

⚖️ This is the gap I have been working on for the past two years at NexTrial.ai

We are building AI for clinical trials that does not produce confidence scores. It produces what we call proof certificates. Documents the inspector can actually read. The rule that was applied. The patient values that were checked. The exact verification that ran. What the AI deliberately did NOT decide, and left for the human doctor.

Four properties. Reproducible. Inspectable. Defensible in court.

🌎 Brazil moved first on this. CFM Resolution 2.454 mandates explicability for any AI used in regulated medical decisions. The European Union AI Act now requires the same thing, quietly, in three different articles. The United States and India will follow.

The vendors who are building toward this architecture today will be ready. The vendors who are not will be re architecting under deadline pressure tomorrow, while their customers absorb the regulatory risk.

📖 I just published a long form essay on this. It is the longest piece I have written, almost 5,000 words, written for regulatory affairs leads, ethics board members, and the doctors who carry the liability when AI is wrong.
It also lays out six questions the framework leaves open. Honest, public, unresolved. The kind of questions a field has to answer in conversation, not in private.

In June, I will be presenting this work at the DIA 2026 Global Annual Meeting in Philadelphia.

Until then, the document is open. The arguments continue. The architecture evolves.

✅ Provably right, not probably right.

That is the standard.

The certificate is the proof.

A confidence score cannot be reconstructed under inspection. A proof certificate can. Before DIA 2026, the field has to decide which one counts.

12/03/2025

🇮🇳 India Feasibility Signals Summit — Full Replay Now Live! 🇮🇳

We brought together feasibility managers, sites, EC members, CRO leads, and research innovators across India to answer one urgent question:

👉 What signals actually define site readiness in India?

This video includes:
✔ The first 12 minutes of the live Summit
✔ The full Menti readout (High / Medium / Low Signals)
✔ Activation delays and root causes
✔ What sponsors really want to see in the first 60 seconds
✔ The unanimous push to launch the India Feasibility Signals Consortium

🎥 Watch the full replay here

If you work in:
• Feasibility
• Start-Up
• Regulatory Affairs
• CRO Operations
• Site Leadership
• EC/IRB
…this is a must-watch.

Together, we’re building a shared readiness standard for India — clearer signals, faster activation, and stronger sponsor trust.

👉 Join the India Feasibility Signals Consortium: https://www.linkedin.com/groups/16198014/

NexTrial.ai — The Deterministic AI Orchestration Layer for Clinical Trials
https://nextrial.ai

09/16/2025

🚨 The Clinical Trial Crisis Nobody's Talking About
67% of clinical trials happen in just two regions: North America and Europe.

Meanwhile, regulatory bodies worldwide are demanding proof that therapies work for THEIR populations:
🇺🇸 FDA: "Include diverse populations"
🇧🇷 ANVISA: "Consider Brazilian demographics"
🇲🇽 COFEPRIS: "Show Mexican population data"
🇮🇳 CDSCO: "Prove efficacy across Indian subgroups"

The result? Billions of patients—rural communities, indigenous populations, aging demographics—systematically excluded by design.

This isn't a diversity problem. It's a regulatory translation crisis.
In oncology alone, only 1% of trial participants are Hispanic/Latino. Rural populations face massive barriers despite representing 20% of Americans.

While most companies digitize the maze, we're deleting it.

✅ Our Trial Activation Intelligence designs protocols for global populations from day one
✅ Anticipates regulatory requirements across jurisdictions
✅ Turns compliance into competitive advantage

Early adopters report 40% faster enrollment and 60% fewer amendments.
Because breakthroughs should reach everyone, not just the convenient populations.

👉 Read the full analysis: https://open.substack.com/pub/steventhompsonai/p/the-protocol-population-disconnect?r=5jp655&utm_campaign=post&utm_medium=web&showWelcomeOnShare=true

The global trial crisis: protocols built for convenience, not the populations they’re meant to treat.

07/16/2025

🎯 Want to run more clinical trials — with less chaos?

We built an AI co-pilot named Celina to help physicians like you start trials faster by automating 6 key readiness steps.

Before Celina, sites were juggling spreadsheets, emails, outdated forms, and sponsor back-and-forths.
Now? They’re activating in days.

I just dropped our full Trial Readiness Playbook for Physicians — the exact checklist + AI-powered strategy we use to help you go from “interested” to “activated.”

📘 Inside the FREE playbook:
✅ Step-by-step manual readiness process
✅ Capacity + recruitment calculators
✅ Documentation audit & cash flow checklist
✅ How Celina upgrades each workflow (Before/After table)

💥 Time saved: 15–20 hours/month per trial
💥 Bonus: 5 most common failure points from 500+ site audits

🎥 Watch Celina explain it herself 👇
📩 DM me “Playbook” or drop a 💡 below and I’ll send you the PDF directly.

Let’s make trials smarter —

07/07/2025

🚨 Big news from NexTrial.ai! 🚨

Meet Celina — the first AI-powered Regulatory Co-Pilot for clinical trials.
She’s not another chatbot. She’s built to support physicians, not overwhelm them.

📋 What she does:
✅ Handles FDA & IRB prep — automatically and compliantly
✅ Turns 60–120 day startup cycles into 30–45 day activations
✅ Translates complex compliance into clear physician actions

💡 What she replaces:
❌ Endless email threads
❌ Form errors and guesswork
❌ Confusion about who owns what

Every trial makes her smarter.
Every activation makes her faster.
She’s your Regulatory Intelligence System — and she’s just getting started.

🧪 Beta Release 2 is now open!
If you're a physician ready to bring clinical research to your community:
👉 Sign up with your NPI at https://nextrial.ai

Let’s build a smarter, faster, more equitable future of research — together. 💙

07/03/2025

If you’re a physician, you’ve probably seen the opportunity to join a clinical trial...

…and then walked away because of:

⏳ 90-day onboarding timelines
📋 Endless paperwork
💬 Confusing IRB and regulatory processes

We built Celina to change that.

She’s not a chatbot. She’s your co-pilot.

✅ 30–45 day onboarding
✅ IRB & FDA prep — already handled
✅ Built to support you, not bury you in admin

Clinical research shouldn’t require you to be a lawyer or a project manager.
You should just show up, bring your expertise — and make an impact.

🎥 Meet Celina. Launching July 7.
🌐 https://NexTrial.ai

06/25/2025

🚀 From MYCIN to NexTrial.ai: How AI Is Rewriting Clinical Research

What started in dusty university basements as expert systems like MYCIN has evolved into real-time agentic AI that’s helping physicians and CROs activate sites faster, recruit smarter, and stay audit-ready.

And we’re not building theory.
We’re live. 🔴

🧠 Over the last 40 years, AI in clinical trials has moved through 4 major waves:

✅ 1980–2000: Expert Systems
📊 2000–2015: Data Mining & ML
🔍 2016–2024: NLP + Predictive AI
🚦 2025+: Agentic AI & Orchestration (this is where NexTrial.ai lives)

Today, our platform is helping site networks and physician groups:

⚡ Validate trial readiness in real time
🧠 Match physicians with the right studies
🛡️ Submit audit-ready trial packets automatically

If you're part of a CRO, research site, or physician network and you're tired of dashboards, delays, or missed matches; come see how we’re redesigning clinical trial coordination.

🌐 Https://NexTrial.ai
📩 Or message me directly to explore our Beta.

Let’s reimagine trial readiness. Together.

06/11/2025

Let’s be honest:

Most physicians would love to be part of clinical research.

✅ Contribute to science
✅ Help patients get access to new treatments
✅ Build their career beyond the daily grind

But almost every doctor says the same thing:

“I wouldn’t even know where to start.”

And that’s exactly where NexTrial comes in.

We don’t just match you to trials — we PREPARE you to lead them.

✅ We break down the protocol
✅ We translate inclusion/exclusion into real patient criteria
✅ We help your staff align on roles
✅ We give you confidence BEFORE the first enrollment

You don’t need more certifications.
You don’t need to join an elite research center.

You just need the right support to start.

The truth is:
**You’re already qualified. You just haven’t been activated yet.**

👉 If you’ve ever thought about leading a trial — this is your chance.

Beta is now open → https://nextrial.ai

06/08/2025

40% of clinical trial sites fail.
But it's not about patients—it's about readiness.

We built TRAP to fix this.
Ddive into Dispatch #9 → https://open.substack.com/pub/nextrialdispatch/p/trial-forward-dispatch-9-40-of-sites?r=5jp655&utm_campaign=post&utm_medium=web&showWelcomeOnShare=true

06/05/2025

We don’t ship features.
We ship outcomes.

Last month, a partner told us:
❝ Our trials are stalling. Coordinators are overwhelmed. Can we fix it—together? ❞

So we shadowed their team.
Listened to their physicians.
Prototyped new flows.

→ 60% reduction in manual screening
→ Higher physician engagement
→ Total buy-in from day one

This is what co-creation looks like.
It’s not about shiny AI.
It’s about building *with* people—not just *for* them.

🧠 AI is the engine.
💬 Trust is the interface.
⚡ Outcomes are the product.

🧭 Read the full story: [Link in bio]

05/24/2025