Independent validation of AI-derived R&D decisions founder@hypothex.ai  ·  Book a scoping call

Your AI says the molecule is the answer. A reviewer will ask how you know.

HypotheX produces the documented, FDA-traceable answer: the warrant chain behind a high-stakes R&D decision, written to hold up under audit.

Warrant holdsthinsknowable gap
Mapped to the frameworks your reviewers use
FDA risk-based credibility, Jan 2025 Context of Use EMA reflection paper on AI ICH E9 21 CFR Part 11
The problem

AI generates faster than any team can verify.

When an AI tool points you to a target, a dose, or a claim, the model is confident and the clock is running. The decision that follows can carry $50M to $500M. The question that follows it is simpler and harder: how do you know the call was sound at the time you made it.

We write that record. We do not predict outcomes. We do not attribute intent. We make decisions defensible, or we show you, precisely, where they are not.

What we deliver

Three engagements, one record you can hand to a reviewer.

01

Hypothesis Audit

For R&D leadership and CSOs

We document the warrant behind a target or mechanism call before you commit the budget that rests on it.

from $25KScope it ›
02

Pre-Submission Evidence Package

For Regulatory Affairs leaders

We build the traceable record at the moment of the decision, so the answer is on file before the reviewer asks.

from $25KScope it ›
03

Patent-Prep Audit

For patent counsel

We document the grounding behind an AI-derived invention before you file, so it holds when the challenge comes.

from $25KScope it ›

Engagements start at $25K. A Pilot Validation Phase covers one decision at fixed scope. Full engagements scale by decision count and stakes.

Featured engagement

Pre-Submission Evidence Package

When a reviewer asks how an AI-derived claim was reached, "the model suggested it" won't hold. Reconstructing the rationale after the fact burns weeks of senior time and still reads as defensive. We assemble the traceable record while the decision is being made.

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  • Warrant chain documentation for the decision
  • The supporting evidence trail, externally grounded
  • A plain statement of where it is defensible
  • Written for a reviewer, not for the model
Where it saves

One audit. Cheap insurance against a decision that isn't.

A high-stakes advancement runs $50M to $500M. The audit that documents whether it's defensible starts at $25K. The asymmetry is the point.

Reconstruction

Rebuilding the rationale after the fact

Months later, recovering why an AI-derived call was made burns weeks of senior time and still reads as defensive. We write the record at the moment of the decision.

Patent challenge

An invention questioned years later

An AI-derived invention is only as strong as the warrant you can show. We document the chain before you file, so it holds when the challenge comes.

Phase 3 commit

A large bet on a thin foundation

If the warrant is weak and undocumented, you find out after the readout, when the budget is gone. We surface it before you commit.

Method

A decision is defensible when the evidence behind it can be shown.

1

We start with one decision

You bring a single high-stakes call and the claim it rests on. We work on it as it stood when it was made.

2

We separate evidence from output

We sort what grounds the claim from what only repeats the model's own conclusion. A confident answer isn't evidence.

3

We test how far it carries

We mark the line: where the warrant holds, where it thins, and where a gap is knowable right now.

4

We write the record

You get a warrant chain document: a band, an action, and the evidence trail, written for a reviewer to read.

Method grounded in the published framework of Romanchuk and Bondar (2026). We never use a later outcome to grade an earlier decision, and we disclose how every assessment was produced. Read our independence policy.

Case studies

The framework discriminates before the readout, not after.

Dermatology · $1.1B acquisition

A target-engagement call inside an M&A decision

Where the warrant held and where it thinned, documented from the evidence available at the time of the deal.

Neuroscience · Alzheimer's

A within-class pair, split on warrant

Two decisions in the same class, separated on target-engagement strength known before either readout.

Oncology · retracted findings

When the source itself fails

What a grounding check surfaces when the published evidence behind a decision later comes apart.

Six cases in full, including sealed prospective assessments made before the readout.

Request the full portfolio Available under NDA.
Who we work with

Built for the people who answer for the decision.

Heads of R&D and CSOs

Before a budget commits to a target an AI tool helped select.

Regulatory Affairs leaders

When an AI-derived claim has to survive a reviewer's question.

Heads of Innovation, mid-market biotech

The fastest path to start, one decision at fixed scope.

Patent counsel

When an AI-derived invention has to hold under challenge.

Principal and independence

An independent practice, by design.

HypotheX is founder-led and works to a published method and a published independence policy. We work for the integrity of the evidence, not for a predetermined conclusion. That independence is what makes the documentation hold.

We do not build the model, own the asset, or get paid more if the assessment lands favorably. The unfavorable finding is the one you paid us to catch.

Read our independence policy ›

PrincipalAlex Bondar, Founder
MethodRomanchuk & Bondar (2026)
LinkedInView profile
MembershipRAPS
Insights

We read the FDA in real time.

2026

A validated model is not a defensible decision

Read on Substack ›
2026

Reading the FDA's risk-based credibility framework

Read on Substack ›
2026

What a warrant chain looks like for a target-engagement claim

Read on Substack ›
Start here

Request a scoping call.

Tell us the decision you want validated. Thirty minutes, no obligation.

Or email founder@hypothex.ai.