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Life Sciences · Biopharma R&D · Translational · RWE/HEOR · CROs · Precision medicine

The protocol is ready. The data underneath it isn't.

Every multi-site study starts over: new sites, new schemas, new mapping, new six months. Axiomera turns fragmented research data into cohorts that are standards-bound, confidence-scored, and traceable field by field back to the source value. Inside your own cloud, with raw records never leaving the sites that hold them.

The question · 47 silos

"Does time-to-next-treatment differ by EGFR co-mutation in stage IIIB NSCLC?" Same fact, five spellings. And some of it isn't a field at all.

EGFR L858R+ "exon 21 L858R" unstructured only
Standardized

Each source resolves into FHIR resource shapes. Observation, Condition, MedicationRequest. Standard format; not yet shared meaning.

FHIR · OMOP-ready
Terminology-bound

Codes snap on with calibrated confidence. Below threshold routes to a human reviewer, not to production.

SNOMED · LOINC · conf 0.97 0.68 → review lane
Harmonized at scale

One longitudinal timeline. Index date, biomarker date, treatment lines, progression. Multiplied across every site in the study. The sites keep their data.

47 sites still lit
One cohort that holds up

What ships is not a merged record. It's an evidence artifact: cohort N, data dictionary, inclusion/exclusion, per-field lineage, append-only audit ID, reproducible.

0 raw records moved
47
U.S. institutions federated
0
raw records moved off-site
0.76
AUROC, 30-day readmission
The problem, in numbers

Studies don't stall on the science. They stall on the data.

The statistical plan is rarely the bottleneck. Getting 47 institutions to mean the same thing by the same date is. Most of the effort in a multi-site study is spent before a single analysis runs, and most of it gets thrown away when the next study adds a site.

60%
of AI projects will be abandoned through 2026 when unsupported by AI-ready data
30%+
of generative AI projects abandoned after proof of concept; poor data quality first cause named
70%
of gen-AI adopters report difficulty governing, integrating, and preparing data for AI

In oncology, the variables that decide a study. Biomarker status and test date, stage, progression, recurrence. Frequently exist only as unstructured text. That is why manual chart abstraction is still the default, and still the cost ceiling.

Regulatory context

FDA relaxed what you have to send. It did not relax what you have to prove.

December 2025's final guidance on real-world evidence for medical devices lets sponsors submit without participant-level identifiers. It changed the form of the submission, not the standard. Sponsors are still expected to demonstrate data provenance, document every preprocessing step, and address sources of bias with the same rigor applied to trial data.

Provenance, captured. Not reconstructed

Lineage is recorded as the data is transformed. It isn't a document written from memory at the end of the study.

Every transformation documented and scored

Each binding carries a calibrated confidence value and the identity of whoever approved it when it fell below threshold.

Reproducible on demand

An append-only log means last year's cohort can be rebuilt exactly as it was, including the mapping decisions in force at the time.

To be explicit: Axiomera makes no regulatory claims. It supplies audit-ready lineage and provenance so your team can make its own case. Any statement about acceptability rests with your regulatory function, not with us.
Use cases

Six studies that are hard for one reason.

None of these are analytics problems. They are all the same data problem, which is why one foundation clears all six.

01

Multi-site RWE study harmonization

Feasibility across N sites without an N-month ETL project per site. Ships an analysis-ready cohort with a data dictionary and lineage attached.

02

External control arms & real-world comparators

Assemble a comparator cohort across institutions where the arms live in different systems. Federated by construction, since nothing has to move.

03

Oncology real-world datasets

Recover the variables that exist only in unstructured text. Biomarker status and test date, histology, stage, progression. Bound to standard terminologies with confidence scores instead of abstracted chart by chart.

04

Federated research networks & consortia

Academic-industry collaborations, disease registries, and cross-border networks where partner sites will collaborate but never transfer rows. A container per site; results move, data doesn't.

05

Translational & multimodal data readiness

Genomics, pathology, imaging, and clinical data joined on the same patient timeline. So a translational hypothesis can be tested against real cohorts, not one study's curated extract.

06

Post-market safety, label expansion & HEOR

One harmonized layer reused across safety-signal monitoring, label-expansion evidence, and payer/HTA dossiers. Instead of three curated datasets that disagree.

Why Axiomera is different

Your model, your cloud, your schema. Nothing leaves the sites.

The usual approach
Axiomera
Maps once into a CDM, then re-maps every time a source drifts.
Binds meaning continuously and self-heals as sources drift.
Stops at a shared format. Valid FHIR that still disagrees.
Reconciles shared meaning, then emits OMOP or your own analysis schema.
Curates one study's extract, for that study.
Builds a layer you keep and reuse for the next study.
Moves data to a central environment to clean it.
Runs as a container inside each environment. Nothing leaves.
A black box the reviewer has to trust.
Every field scored, lineage-traced, and human-escalated below threshold.
Case study · Federated learning across 47 institutions

Privacy-preserving harmonization, published.

The research question spanned 47 U.S. healthcare institutions with no central repository and no transfer path. Which is precisely why it had been unrunnable. Axiomera performed semantic binding and harmonization in place, at each institution. Each site computed on its own records, only differentially private gradient histograms crossed the network, and the federated model reached an AUROC of 0.76 for 30-day readmission, an absolute gain of 0.08 over institutional baselines. Published in Informatics in Medicine Unlocked (Elsevier).

47
institutions federated
0
raw records moved off-site
0.76
AUROC, 30-day readmission
Published · DOI 10.1016/j.imu.2026.101772 USPTO allowance · App 19/181,522 Federated Privacy-preserving
Objections, answered

The four questions your informatics lead will ask.

We already have OMOP.
Then keep it. OMOP is a destination, not a competitor. The expensive part was never the CDM. It was the source-to-concept mapping, and re-mapping it every time a site, a vocabulary release, or an EHR upgrade moves underneath you. Axiomera does the semantic binding and hands OMOP the result, with a confidence score and a lineage trail on every field your ETL currently delivers unlabeled.
Our CRO handles this.
For that study, yes. What you get back is one curated extract, and the mapping knowledge leaves with the engagement. So the next study buys it again. Axiomera leaves the layer inside your environment, so study two starts where study one finished. CROs are welcome to run it themselves; several of our conversations are with CROs, not around them.
Can this feed an FDA submission?
We won't claim that, and you should be suspicious of anyone who does. FDA holds you to demonstrating provenance, documented preprocessing, and bias handling. What Axiomera provides is the substrate for that argument: every harmonized value traceable to its exact source value, every transformation scored and recorded in an append-only log, and a cohort you can rebuild exactly as it was. Your regulatory team makes the case; we make sure the evidence for it exists.
We're already a TriNetX / Flatiron / Aetion / Truveta shop.
Those are data assets and analytics environments. Axiomera is the harmonization layer underneath whatever you already licensed. Plus the sites and internal sources no vendor covers: your own EHR feeds, your registry, your partner institutions, your legacy pathology and genomics. Most teams already run two or three platforms. The layer is what makes them agree.
The foundation underneath

Lineage on every field. An audit log that can't be rewritten. Data that never moves.

Full lineage & provenance

Every harmonized value traces to the exact source value in the exact source system.

Append-only audit trail

Quality-scored and human-approved. Entries are added, never edited.

Confidence-routed automation

Low-confidence bindings escalate to a person before anything is committed.

Deploys in your cloud

Snowflake native app, AWS, GCP, or Azure. With your BAAs unchanged. Snowflake partnership signed; SOC 2 Type II in progress; one USPTO patent with a Notice of Allowance.

Start with method, not marketing

Bring us the study you couldn't run. We'll show you the cohort.

Send a study design that died on data access, or a data dictionary from one difficult site. We'll walk your team through exactly how each field gets bound, scored, and traced. And what the cohort looks like on the other side.