M01 · Talaria Intelligence

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M01 · Prospective · Shipped core

Ask while the protocol can still change.

Will this design survive Phase III — and what would have to change for it to?

Intelligence is the surface you address before you commit. It takes a trial as drafted and returns a calibrated interval for the outcome, together with the specific design levers that move it. It exists for the narrow window in which the answer is still actionable: once the protocol is registered and enrolling, a probability is a forecast; while it is a draft, the same probability is a decision.

Takes
A trial draft
Asked
Before it runs
Returns
An interval & its levers
Status
Shipped core

validation scores · the design-time prediction head on held-out trials

In plain terms

What Intelligence actually does for you.

Plain Englishno jargon — the one-paragraph version

A late-stage trial costs years and hundreds of millions of dollars. Most trials that fail were not the wrong drug — they were the wrong trial: an endpoint too blunt to see the effect, a population that diluted it, a cut-off set a notch too wide. Intelligence reads your trial while it is still a draft and tells you two things a spreadsheet never can — how likely this exact design is to succeed, and the handful of changes that would most improve its odds.

The difference is timing. Once the protocol is registered and enrolling, a prediction is just a forecast you watch come true. While it is still a draft, the same prediction is a decision you can still act on — and every answer arrives with the specific change that would move it.

For the clinical lead

Point Intelligence at your draft protocol. It returns a calibrated range for the outcome and ranks the design decisions by how much each one moves that range — so the redesign conversation starts from evidence, not opinion, while the protocol can still be edited.

For the data-science reviewer

A calibrated head over one shared trial representation anchored to a causal map. The counterfactual panel reports intervention effects on five fixed design axes with an epistemic / aleatoric uncertainty split, subgroup (CATE) conditioning, a two-path disagreement monitor, and an Ed25519-signed audit row per prediction.

DESIGN LEVERS Enrichment cutoff Primary endpoint Population Powering Line of therapy one lever moved · four held fixed PREDICTED OUTCOME clears → as drafted · misses the endpoint as revised · one lever moved, it clears 0 0.5 1 probability of clearing (schematic)

One lever, moved. Same drug, same trial — only the enrichment cut-off changes. As drafted, the outcome interval sits below the bar and the trial misses; revised, it clears. A hand-authored synthetic fixture, not a measurement.

What it returns

Four things travel with every answer.

01

A calibrated interval, never a point

The output is a range with an explicit uncertainty envelope, split into the part that shrinks with more evidence and the part that does not. A single number would imply a precision the evidence does not support.

02

A counterfactual panel

Five design levers — enrichment cutoff, primary endpoint, population, powering and enrollment, line of therapy — each carrying its own causal interval. This is the part a leaderboard model cannot produce.

03

Subgroup-conditional estimates

The pooled interval fans into strata that frequently disagree. A design that clears on the pooled estimate can still fail on the population you are actually able to enroll.

04

A calibration state and a signed audit row

Whether the model considers itself trustworthy for this trial today, and a cryptographically signed record of the model, features and substrate versions behind the answer.

How it works

One substrate, addressed at a different moment.

Every prediction is a calibrated head over one shared representation of a trial, anchored to a causal map. New predictive capacity is added as a head plus a counterfactual panel — never as an eighth base learner. That constraint is what keeps the levers interpretable: the panel reports changes in a fixed causal structure rather than the shifting attributions of an ever-growing ensemble.

Limits

What this surface does not claim.

Stated plainly, because a capability page that omits them is marketing rather than documentation.

The levers are unranked, deliberately

Ranking them would require a reconciled canonical-metric record that does not yet exist. Presenting an order we cannot defend would be the most useful-looking and least honest thing this page could do.

One head ships today

The subgroup-conditional Phase 2–3 head, with its counterfactual panel. The remainder of the roster is designed and queued, not deployed.

The scores are validation, not a warranty

The figures above are held-out validation scores for the shipped design-time head. Live performance depends on your trial and its data and is not warranted — and a score read outside its evaluation conditions is worse than no score.

Not authorized

No FDA authorization exists. A SaMD De Novo submission is a planned milestone, not an achieved one.

See it run

An interactive demo on a synthetic composite.

Every value in the demo is a hand-authored fixture. It is there to show the shape of the output and how it responds — not to report a measurement.

The other two surfaces

Same engine, different moment.