Clinical trial feasibility, decided on evidence
Know if the trial is worth running — before you commit.
Upload the protocol, or just name the molecule and indication. In hours you get a six-pillar feasibility assessment and a go/no-go verdict — every number traced to the public record it came from. Built for biotechs, CROs, and the investors who back them.
ENDO-2b · Endometriosis Phase 2b
Feasibility verdict · every number cited
Built on public data sources
Public, re-verifiable sources — click any number to check it yourself. Your protocol is never used to train a model.
These 7 backbone registries are part of ~50 live connectors feeding the engine.
Who it's for
One question, asked from four sides of the table.
Whether you're running the trial, bidding on it, or backing it — the decision is the same: is this study worth the money? The evidence should be too.
Biotech & sponsors
Pressure-test your own asset before an irreversible bet. Design, patients, sites, cost, and commercial upside — one assessment your board can interrogate line by line.
See plans →CROs
Put a cited feasibility verdict in the bid, white-labelled under your brand — and when the sponsor challenges a number, point to its public source.
For CROs →Venture & private equity
Diligence a lead asset in hours, from public data alone: probability of success, why comparable trials failed, patent runway, and a risk-adjusted valuation.
For investors →Public-market analysts
Read a sponsor’s trial the way an operator would — enrollment reality against competing trials, adverse-event signals, and delay signals from SEC filings and earnings calls.
For investors →The problem
A multi-million-dollar go/no-go shouldn't rest on a report you can't audit.
If you run a CRO bid team, you know the math: a $100k, six-week feasibility cycle is fine when you win the bid and unsustainable when you lose it — and a sponsor can still pick the number apart. The same is true for a biotech making an irreversible bet, and for an investor deciding whether to back one. Today that evidence arrives slow, opaque, and impossible to check.
Speed
A six-week CRO feasibility questionnaire is too slow for a go/no-go decision that keeps moving. By the time the report lands, the window has narrowed.
Defensibility
When your board, an investment committee, or the FDA asks where a number came from, "the model said so" is not an answer. You need a verdict anyone can trace back to a public source.
Cost
Bespoke feasibility consulting costs five or six figures per protocol — before you have even decided whether the trial is worth running.
How it works
Study in. Cited verdict out. In hours.
Describe the study
Upload the protocol, or start from just the molecule (or drug class) and the indication — enough for a full public-data assessment even before a protocol exists. Your documents are processed privately in the EU and never train a model.
The engine gathers the evidence
Around 50 live public sources are pulled for your study: ClinicalTrials.gov and national trial registries worldwide, PubMed, FDA and EMA precedent, pharmacology databases, patents, pricing, and SEC filings — each record pinned to the exact snapshot it was read from.
You get an assessment, not a guess
Six pillars, 30+ analyses, and a go/no-go verdict — every number cited to its source. Expert-role workspaces then draft the memos and plans your decision needs, and your team signs off with a Part 11 electronic signature.
The assessment
Six pillars. One defensible answer.
Every study gets the same structured work-up — more than 30 analyses across six pillars, each one cited to the public records it was built from.
Rationale
Should this drug work?
The scientific case for the asset, checked against public target and pharmacology evidence.
- Target validation
- Binding affinity
- Off-target & interaction risk
- Structural viability
Design
Is the trial designed to win?
Your design against the indication norm — and against every comparable trial that failed or succeeded before you.
- Competitive landscape
- Why comparable trials failed
- Design vs. indication norm
- Statistical power
- Regulatory-precedent timeline
- Protocol-amendment risk
Cohort
Can you find the patients?
How many eligible patients actually exist, and how much your eligibility criteria shrink the pool.
- Cohort sizing
- Eligibility complexity
- Real-world cohort
Where & How
Where do you run it — and at what cost?
Sites and investigators on a map, ranked by track record and competition, with an honest budget band.
- Study sites & contacts map
- Site & investigator selection
- Site density vs. competition
- Geographic prioritisation
- Cost feasibility
- Operational benchmarks
Commercial
Is it worth it if it works?
The commercial case behind the clinical one — market, price, standard of care, and patent runway.
- Market sizing (TAM / SAM / SOM)
- Risk-adjusted valuation (eNPV)
- Value-based price
- Standard of care
- Patent landscape & exclusivity
Verdict
Go, or no-go?
Everything above rolled into one recommendation — with the risks that could still change it.
- Go / No-Go recommendation
- Probability of success
- Operational-risk dashboard
- Adverse-event signal
- Sponsor delay signals (SEC filings)
- Verdict interpretation
Expert roles
The assessment is the start. The deliverables are the point.
Seven expert workspaces turn the assessment into the documents your decision actually needs — a Go/No-Go memo, a protocol synopsis, a statistical analysis plan, a dose-selection memo, valuation scenarios. Drafted with citations; reviewed and signed by your team.
Protocol Design
Drafts the trial protocol synopsis from the verdict, design, and cohort analyses — every claim cited.
Commercial Strategy
Market size, standard of care, value-based price, patent runway, and risk-adjusted valuation scenarios.
CMO / VP R&D
Portfolio-level valuation, decision-gate memos, and readout-risk framing for the go/no-go call.
Biostatistician
Statistical analysis plans, sample-size estimates, and data-monitoring-board materials.
Clinical Pharmacologist
Dose-selection memos, exposure–response modelling, and drug-interaction risk.
Study Start-up
Country activation tracking and contract groundwork for the sites the assessment ranked.
CRO Commercial
Bid-pipeline and portfolio views for CRO business development teams.
Your team signs off
Every deliverable is approved with a 21 CFR Part 11 electronic signature. If the underlying evidence later changes, the signed decision is automatically flagged for re-review — nothing stays approved on stale data.
Why trust the number
The opposite of a black box.
A feasibility verdict is only useful if you can defend it — to your board, a sponsor, an investment committee, or the FDA. So every claim can be checked, and every decision made on it is governed.
Every number, cited
- Every figure links to the public record it came from — click it and check
- Evidence is graded honestly, from single-source up to triangulated
- Uncertain numbers say so — no false confidence, ever
- Built on public data anyone can re-verify, not a proprietary black box
Every decision, governed
- Go/no-go decisions signed with 21 CFR Part 11 electronic signatures
- If the evidence changes, signed decisions are flagged for re-review
- Full version history — watch the verdict evolve as new data arrives
- Your protocols and documents stay yours, never used to train a model
How it compares
Faster than a CRO. Defensible unlike a chatbot.
A feasibility verdict that's quick to get and impossible to wave away.
| Capability | CRO questionnaire | Black-box AI | Clinical Trial OS |
|---|---|---|---|
| Turnaround | 4–6 weeks | Minutes | Hours |
| Every number traced to a public source | |||
| Honest about uncertainty (evidence grades) | |||
| Audit trail & e-signature sign-off (Part 11) | |||
| Your protocol never trains a model | |||
| Cost per study | 5–6 figures | Low | Flat per-study |
Founding cohort
Onboarding a small founding cohort of design partners.
We are taking on a handful of biotech, CRO, and investment teams to run real feasibility work with us — before we scale. If that is you, the door is open.
Run your real protocols
Bring live feasibility questions, not toy examples — every verdict is cited back to public data you can check.
Shape the roadmap
Tell us where a verdict is wrong. Founding-cohort feedback sets what we build next and earns preferential pricing.
Named only with consent
We will never show your logo or name until you have explicitly agreed to be a public reference.
Pricing
Per-protocol or annual. No per-seat.
Pay per feasibility run, or go annual for high-volume (fair-use) protocols across your team.
FAQ
Questions, answered honestly.
See a verdict you can actually check.
Send us a protocol — or just a molecule and an indication. We'll return a fully cited feasibility assessment you can trace, line by line, back to public data — yours to defend in a bid, take to your board or investment committee, or hand to a regulator.