Case

Example: one "clinical trial"
held as one holon

AXION-3 answers 500 competency questions, describe, prescribe, and predict, from the same four graphs, live, instead of a protocol document reconciled by hand against a CTMS, an EDC, a safety database, and a stack of biostatistics outputs.

Synthetic / illustrative data. AXION-3 is a fictional Phase III trial sponsored by a fictional company, DISYNPHiA, built entirely from generated data to demonstrate this pattern. No real patient, site, or sponsor appears anywhere below, including in the interactive dataset.

the trial

AXION-3, Phase III, second-line pancreatic cancer

A randomized, double-blind, double-dummy trial of MRX-302 (voxacerib), an oral RAS multi-selective inhibitor, against chemotherapy in second-line metastatic pancreatic ductal adenocarcinoma. Dual primary endpoints, overall survival and progression-free survival, are assessed in the RAS-mutant primary population by blinded independent central review. Two protocol amendments and three DSMB reviews already sit in its history, and every one of them is a governed event, not a footnote.

Phase III · double-blind 500 randomized · 560 screened 58 sites · 6 countries Second-line mPDAC Dual primary · OS & PFS 2 amendments · 3 DSMB reviews ~16,000 event-ledger entries 500 competency questions
the walkthrough

The problem, the limit, the holon

The protocol, the CTMS, the EDC, the safety database, and the biostatistics outputs each hold one slice of AXION-3, and disagree at the edges.

Protocol MRX302-301, 58 sites, 500 randomized subjects, dual primary endpoints OS and PFS in the RAS-mutant population. Everyone agrees this is the trial. Reconstructing its exact current state, why one number is what it is, right now, means opening five systems and reconciling them by hand.

Each system was built for its own job, not for one shared, defensible truth.

  • Site status, enrollment, safety, and drug supply each live in a different system, none built to answer the others' questions.
  • The 16 eligibility criteria, the visit-window rules, and the endpoint-derivation rules live in the protocol PDF, not in anything that can reject a bad entry.
  • Provenance, who changed what, when, and why, across roughly 16,000 events, is reconstructed by hand before every DSMB review and every inspection.
  • A compliance report is a project someone runs before a milestone, not something the system already knows.

Modeled as a holon, AXION-3 is one identity, expressed through four coordinated graphs.

Scene · what is true now

58 sites in 6 countries · 500 of 560 screened subjects randomized · dual primary endpoints in the RAS-mutant population · 2 protocol amendments · 3 DSMB reviews · data cutoff 2026-06-15.

Boundary · what must hold

16 eligibility criteria · visit-window rules · endpoint-derivation and censoring rules · blinding and emergency-unblinding procedure · 7 risk-based monitoring thresholds · 10 regulatory anchors (ICH, 21 CFR, EU CTR, CDISC, ISO 14155).

Event · what happened

~16,000 sorted entries: site activated, subject randomized, visit completed, AE reported, tumor assessment performed, query opened or closed, dose dispensed, amendment approved, DSMB review, database lock.

Projection · who sees what

Seven role views, investigator, monitor, medical monitor, biostatistician, executive, regulatory affairs, plus a predictions view: survival maturation, database-lock forecast, safety-signal alerts, site-risk escalation.

What it produces

  • One current state every team, from investigator to executive, reads from the same source.
  • A compliance report computed on demand, not assembled once a quarter.
  • A full, ordered history behind every one of 500 competency questions.
  • Seven role-specific views and a set of explainable predictions, all computed, none re-entered.
the product

One compound, one identity, resolvable everywhere it's described

AXION-3 exists to generate evidence about a compound, and that compound's identity has to survive, unchanged, across the sponsor's own systems, the EU's CTIS, the EMA's SPOR services, and the FDA's registries. IDMP is the international standard built to hold that identity together: substance, pharmaceutical product, and medicinal product, stacked like a wedding cake.

Substance · ISO 11238

Voxacerib, an oral RAS(ON) multi-selective inhibitor. Stays constant no matter how many dose forms, strengths, or brand names follow.

Pharmaceutical product · ISO 11616 + 11239 + 11240

Film-coated tablet, oral route, three clinical strengths (50, 100, 150 mg). The AXION-3 protocol dose, 300 mg/day, is delivered as two 150 mg tablets.

Medicinal product · ISO 11615

The full regulated record: DISYNPHiA as authorization holder, an NDA/505(b)(1) pathway in the US, a centralised procedure in the EU, and an explicit link back to AXION-3 as the pivotal study behind it.

The point: the FDA and EMA regulatory-milestone timeline reads the same compound identity, and the same data-cutoff date, straight from this holon. Nothing about the product is re-typed for the regulatory track.

the data · 1 of 4 graphs

Scene graph: the study as it stands today

Study record, sites, subjects, adverse events, tumor assessments, queries, and the budget sub-holon, live and searchable, computed straight from the same dataset used throughout this page.

Loading the live dataset…
the data · 2 of 4 graphs

Boundary graph: the rules, and whether they hold

Eligibility, visit windows, endpoints, blinding, safety reporting, regulatory anchors, risk thresholds, and a compliance report computed by checking Scene and Event against these rules, not authored by hand.

Loading the live dataset…
the data · 3 of 4 graphs

Event graph: one traceable ledger behind every fact

Roughly 16,000 sorted entries. Every Scene fact above, and every Boundary check, is derived from this ledger. Search it, filter it by entity type, nothing is re-entered.

Loading the live dataset…
the data · 4 of 4 graphs

Projection graph: the same facts, six different lenses

Investigator, monitoring, medical monitor, biostatistician, executive, and regulatory views, each computed, not re-entered, from Scene + Boundary + Event.

Loading the live dataset…
predict

What the holon projects forward

Survival maturation, database-lock timing, safety-signal detection, and site-risk escalation, all computed with simple, documented methods rather than a black box.

Loading the live dataset…
the proof

500 competency questions, every one answered from the same data

Split across 17 domains and three verbs, describe, prescribe / govern, and predict. Search them, filter by verb or domain, every answer computed directly from the graphs above, not typed by hand.

Loading the live dataset…

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