Damaros

The agentic execution platform
for clinical trials.

A demonstration of the Damaros runtime on synthetic FHIR data. {{ captionHint }}

{{ auto.status }} · synthetic FHIR
Protocol Ingested · locked v2.1 LLM fetched NCT00000204 · parsed sponsor packet · 06-21 14:02Z

DMR-204 · EGFR-mutant NSCLC

NCT00000204 · Phase II · randomized 1:1 · hash aead45cf

Amendment cascade
v2.0 · 04-12 v2.1 · 06-21
Narrowed prior-lines criterion · re-screen triggered
Sponsor
Meridian Oncology Therapeutics
NCT00000204 DMR-204 · v2.1 Phase II
IN
Dr. I. Netero
Medical Monitor
JK
J. Kujo
Lead CRA
jo.okafor@meridian.example
Study arms · LLM-parsed from packet
ARM A
Velartinib · 80 mg PO daily
Investigational · oral 3rd-gen EGFR-TKI
ARM B
Platinum doublet
Comparator · standard of care
Randomized 1:1 · target n=140 · stratified by ECOG & prior lines
Eligibility · 36 criteria · 25 engine-mapped
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Evidence How the Damaros engine maps the sponsor packet onto site evidence · PHI-bounded · 09:43
Sponsor packet → evidence coverageMapped 25 of 36 criteria · Protocol v2.1
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Protocol obligations · source mapping
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Maps to {{ ev.detail.requiredBy }} · {{ ev.detail.arm }}
Current{{ ev.detail.current }}
Source plane{{ ev.detail.sourcesText }}
Checked{{ ev.detail.checked }}
ProvenanceNo model verdict · source trace available
Coordinator step-in
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No judgment required
Computable from source. Maps deterministically once the evidence lands.
Routed · {{ ev.detail.actedTicket }}
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Screening Protocol v2.1
Patient queue · decisive criterion
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Primary blocker
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Normalized rule
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Patient facts used
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Evidence sources
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Deterministic result
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Review trigger
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Recommended next action
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Resolve {{ awaiting }} awaiting judgment · {{ committedCount }} committed

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Decision signed · bound to Replay
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ReviewerYou
Role{{ cur.role }}
Protocolv2.1 · aead45cf
PHIexcluded
Your call
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Replay
Subject S-1047 · DMR-204 · Site 018 · Protocol v2.1 · Run {{ rp.runId }} · 06-22
Reconstruction ledger
TimeEventActorIntegrity
Selected event
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Related events
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Sentinel Opportunity radar

Surfaces open protocols the site's evidence already covers. Aggregate only, no patient data.

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Scanning registriesSynthetic
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{{ t.meta }}
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Surfaced
Sponsor
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PI
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Contact
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Sites
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Enrollment
{{ t.enroll }}
{{ sn.open.tier }}
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{{ sn.open.nct }} · {{ sn.open.phase }}
{{ sn.open.fit }}
{{ sn.open.status }} {{ sn.open.dates }}
Brief summary

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Study design
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Arms & interventions
{{ a.name }}
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Endpoints
Primary{{ sn.open.primary }}
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Sponsor & contact
Sponsor{{ sn.open.sponsor }}
PI{{ sn.open.pi }}
Contact{{ sn.open.email }}
Sites{{ sn.open.sites }}
Enrollment{{ sn.open.enroll }}
Evidence concepts covered
{{ c.label }}
{{ sn.open.ref }} · queued to {{ sn.open.sponsor }}
Shared as aggregate site capacity. PHI-free, no patient-level data. The sponsor sees supply, not a patient.
Trident At protocol

Drafts the amendment that unblocks a stuck criterion, routed for signature.

High-friction criteria
Pick a criterion, then draft the amendment.
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Current · {{ tr.code }}
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Proposed
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Current friction
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Projected · {{ tr.dropText }}
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Unblocks · routed for human authorization
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The case Trident hands the sponsor
Endpoints unaffected. A structural eligibility change only · primary and secondary endpoints are untouched.
Yield. Structural friction falls {{ tr.frictionText }} → {{ tr.projText }} ({{ tr.dropText }}), unblocking the subjects listed above at this site.
Grounded. Drafted against FDA guidance and the ontology-normalized criterion set, not free text.
PHI-free, human-authorized. No patient data leaves the site. Trident drafts; the sponsor's medical monitor signs. It never commits an amendment itself.
Request sent to sponsor · bound to Replay
{{ tr.sponsor }} · SLA 5 business days · PHI-free. The sponsor authors the amendment from Trident's draft.
Eye Site 018 · this run

Surfaces quality signals early, while a correction is still cheap. Aggregate, never a verdict · not surveillance of people.

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Quality signals · {{ ey.activeCount }} need attention
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6-week trend · Site 018
What Eye sees
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Likely cause
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If unaddressed
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Recommended action
Within the control band. No routing needed · Eye stays quiet when nothing needs a human.
Routed · {{ ey.ticket }} · {{ ey.dest }}
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Luna Across the chain

Every action on this trial is an immutable, hash-chained event. Luna reconstructs any finding from the chain in seconds and cites every row it used. It reads the record; it never writes to it.

847
Events in chain
12
Sources reconciled
1.4s
Median trace
Ed25519
Every row signed
Investigations · select one
Select an investigation. Luna reconstructs the finding from the audit chain and cites every row it used.
Reconstructing from 847 audit events…
Finding · reconstructed from the chain
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Evidence · {{ cb.rowCount }} chain rows retrieved
Every claim links to a chain row · read-only.
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Verified in the audit chain.
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The Compatibility

Not a replacement.
One system for the stack.

Works with the software the site already runs.

Veeva
Medidata
Epic
Cerner
REDCap
OpenAI
Claude
The problem

Care is everywhere.
Clinical trials aren't.

Candidates surface. Enrollment is recorded. In between, the funnel goes dark.

~5×

higher trial enrollment at NCI-designated centers (21.6%) than at community programs (4.1%).

Unger et al. · JCO 2024
~80%

of US cancer patients are treated in community settings, about 80–85% across independent estimates.

Tucker et al. · Ann Surg Oncol 2021 · Petrelli · J Am Coll Surg 2010
70%

of US counties had zero active cancer trials in 2022. Care is local; trial access often is not.

Kirkwood et al. · JCO Oncol Pract 2024
~16%

CRC turnover in FY2024 (15.5%). Sites are short on people; replacing one coordinator costs $50K–$60K.

ACRP · 2025
Trial capability

Patients aren't scarce.
Proof is.

Site infrastructure a sponsor can verify.

What we do
Does this subject provably meet this protocol?
Every compiled criterion evaluated against site evidence
Ambiguous ones routed, cited, and signed by a human
The whole chain reconstructable from the record, not from memory

A signed record of a probabilistic decision is not proof. Given the same clinical triage prompt ten times, a leading commercial LLM repeated itself only 49.3% of the time. Replay is reproducible by construction: same protocol, same evidence, same as-of, same verdict, every run.

Franc et al. · JMIR 2024
What we don't do
Accuracy percentages we can't reproduce at your site
Any model casting a verdict on a subject
Eligibility locked without a human-signed record
PHI on a model path

Protocols now absorb a median 3.3 amendments each, up 60% since 2015; sponsors themselves call 45% of those avoidable. Trident recompiles each version into locked logic: re-screens run against the protocol that governs the site, not the one a coordinator remembers.

Tufts CSDD · 2024
The workflow

One run.
Protocol to proof.

Engine accelerates. Humans decide. Replay proves.

01Protocol
Intent becomes logic.

Trident compiles sponsor criteria into locked logic; one locked version runs byte-identical at every site.

LLM on protocol text · deterministic compile
02Evidence
Records become evidence.

Site-approved data arrives screening-ready as of the latest ingest, lineage and mapping intact.

PHI never meets a model
03Screening
A verdict, not a guess.

Deterministic engine evaluates every compiled criterion; anything it can't evidence routes for review.

PASS REVIEW FAIL
04Resolve
Judgment, then signature.

Staged options with cited evidence wait for one sign-off before the run closes.

Citation-bound · one signature
05Replay
Execution becomes proof.

Any run reconstructs end to end from protocol basis through final signature.

Hash-verified chain · Ed25519 on export
The agents

Four agents.
Zero verdicts.

Surface, prove, draft, flag. Never decide.

Sentinel
Opportunity radar

Surfaces open protocols the site's evidence already covers — protocols to sites, never patients to protocols.

Aggregate coverage only · no patient data
Luna
Audit chain

Reconstructs any run from the chain, every row cited.

Read-only on the record
Trident
Protocol intelligence

Compiles criteria into locked logic and drafts amendments.

Never commits an amendment
Eye
Quality signals

Flags drift and deviations before they harden into findings.

Watches process, not people
The outputs

Not a dashboard.
A decision you can defend.

State, evidence, and a signed replay bundle.

Input
Protocol v2.1 · locked
NCT00000204 · hash aead45cf
Site-approved cohort · 72 patients
Synthetic · site-governed
Evidence snapshot · 1,284 resources
FHIR R4 · pop-2026-06-22
deterministic engine
Output · execution record
Subject 018-017
DMR-204 · v2.1 · I-3.4
Review
Serum chemistry within 7-day window
DriverStale · evidence past the freshness window
EvidenceObservation · K⁺ 5.0 mmol/L · drawn 06-09
Epic / FHIR R4 · retrieved 06-20
ActionCoordinator requested repeat panel
ResolveSub-I deferred eligibility pending updated K⁺
ReplayPartially replayable until updated evidence arrives
Reviewer Dr. M. Avdol · PI / Sub-I · bound to Replay · PHI-free
The runtime

Damaros helps
the site execute.

Site-hosted. Site-governed. PHI stays put.

What it controls
Site-approved evidence sources
Review adjudication & clinician confirmation
Local evidence visibility & artifact release
Network-safe signal emission
What it does not
Become a network-controlled endpoint
Expose raw chart browsing by default
Replace clinician judgment
Patient matching or candidacy scoring
Send PHI out of the site or let an LLM touch patient data
Replay

Not a log you trust.
Proof you can replay.

The record a sponsor wants before selecting a site.

Replay ledger RPL-2026-0622-018-1047
01Protocollocked v2.1
02Evidencesnapshot
03Screeningdeterministic
04Resolvehuman-signed
Replaysealed
Protocol basis
v2.1 · aead45cf
Evidence snapshot
pop-2026-06-22
Signature
Ed25519 · verified
Security posture

Every run is attributable.
PHI stays off the model.

Site-bounded controls, ready for audit.

No LLM touches patient data. The architecture, not a setting. PHI is bounded at the site and never enters a model path. Only a third of published LLM-vs-human clinical comparisons favor the model; most rest on non-real data.

Chen, Oermann et al. · Nature Medicine 2026
No sponsor path to raw PHI · aggregate egress
Replayable proof · signed & hash-verified
HIPAA-aligned by design · BAA at the covered entity
Institution-hosted or air-gapped · managed option on request

We validate the execution chain. We do not claim clinical efficacy.

Any clinic. Any trial.
Any patient.