One model.Four systems run on it.

Accura Cortex builds the model of the study. Studio, OS and the EDC are what that model does once it exists.

Request a demo How the model is built

Accura Cortex · the intelligence layer

The protocol, read into a model.Every block points to its clause.

Choose any block to see where it came from. The gap is the point: an unclear clause becomes a question for a person, not a guess.

PROTOCOL · ACC-P1-001AS WRITTEN

Vital signs are recorded at every visit, including systolic blood pressure (60 to 200 mmHg). Safety labs include hemoglobin and creatinine; creatinine above 1.5 triggers a safety review. Adverse events are graded and escalated per the seriousness criteria in Section 9.4.6. Participants receive the assigned dose level. All source data must remain attributable.

Concepts
Forms
Rules
Audit
§6.2.1LOINC 8480-6Systolic BP. Systolic blood pressure, in mmHg (UCUM).Modelled · Resolved against LOINC and UCUM
§8.1.4LOINC 718-7Hemoglobin. Hemoglobin, mass per volume, in g/dL.Modelled · Resolved against LOINC and UCUM
§9.4.2MedDRAAdverse event. Coded to a MedDRA preferred term at entry.Modelled · Resolved against MedDRA
§10.2.1USDM v4.0Dose level. Planned dose, from the administration schedule.Modelled · Resolved against CDISC USDM
§6.2CRF-0112Vital signs. 9 fields, 4 required, 2 branching conditions.Approved · Approved and e-signed
§8.1CRF-0118Lab review. 9 fields with hard and soft checks.Approved · Approved and e-signed
§9.4CRF-0124Adverse events. Draft generated from the protocol.In review · Awaiting the medical monitor
§6.2.1RULE-034160–200 mmHg. Hard range check. Blocks the save outside range.Approved · Approved and e-signed
§8.1.4RULE-0355Sex-specific range. Reference range by sex. Warns outside it.Approved · Approved and e-signed
§8.1.9GAP-0007No unit given. A creatinine limit with no unit. Nothing is generated from an ambiguous clause.Gap · A person decides before this rule exists
§9.4.6RULE-0362AE → SAE escalation. Escalates on the seriousness criteria.In review · Awaiting the medical monitor
§1.3–§10.221 CFR 11.10(e)Every action attributed, timestamped and kept. Who, what, when and the prior value, for the whole study.Modelled · Write-once. No row is ever edited or deleted.

Hover, tap or use the arrow keys · the clause lights in the protocol

  1. IngestProtocol, amendments, specifications and SOPs, every line kept as a pointer.
  2. Resolve“SBP”, “systolic” and “blood pressure” become one concept.
  3. CiteAn output that cannot name its clause is rejected.
  4. GapAn ambiguous clause waits for a person, never a guess.
  5. VersionAn amendment is a diff against the model, not a re-read.

Accura Studio · protocol to study build

The study build,drafted from the model.

Forms, checks and branching come out of the approved model, each attached to its clause, and nothing goes live until a person signs it.

Vital signs · CRF-0112Generated · §6.2
  • Systolic blood pressure mmHg · required · 60–200
  • Diastolic blood pressure mmHg · required
  • Heart rate beats/min · required
  • Weight kg
  • CALC BMI from height and weight
  • PHI Subject initials restricted

9 fields · 4 required · forked from a versioned template

Describe a checkProposal · not yet live

“Systolic blood pressure must be between 60 and 200 mmHg.”

FieldVS.SYSBPOperatorbetweenValue60–200Outcomeblock the save

Approve, and it compiles to RULE-0341 v1 · versioned and deterministic

Branching from §8.1.2Derived, not typed
Protocol conditionWomen of childbearing potential are tested at screening
Form logicSex = Female → show pregnancy test

The condition keeps its clause · change the protocol, the branch follows

Study build · section review2 of 3 signed
  • Vital signs approved · e-signed
  • Lab review approved · e-signed
  • Adverse events awaiting the medical monitor

Activation stays locked until every section is signed

The AccuraTrials validation rules editor on a generated adverse-event form, listing its questions as required or optional with the edit checks attached to each
Edit checks on a generated formThe real editor, on synthetic demonstration data.

Accura OS · the operating layer

One approved model,pushed to every system.

An amendment lands once, instead of being retyped into each vendor console. Here is exactly how far it reaches today.

8 systems
Accura OSOne approved model
  • AccuraTrials EDCLive
  • eConsentPrototype
  • ePRO / eCOAPrototype
  • LabsPrototype
  • SafetyPrototype
  • RTSM / IRTRoadmap
  • ImagingRoadmap
  • CTMS / eTMFRoadmap

Prototype runs against the model in our own environment and has not been through a customer study. Roadmap is designed, not built. AccuraTrials EDC has its own randomization, ePRO and eConsent built in; this map is about connecting the systems you already run.

AccuraTrials EDC · live

Where the model runs,on a paid clinical study.

Data capture built to 21 CFR Part 11, running on the protocol model, so a deviation is flagged against the actual clause.

An AccuraTrials demographics eCRF with all seven questions answered, frozen for review, and a query action beside every field
eCRF frozen for review
A subject record in AccuraTrials showing enrollment details and a visit timeline with per-visit form completion
Visit schedule from the model
The AccuraTrials audit log listing events with category, actor and timestamp for every action
21 CFR 11.10(e)
The AccuraTrials electronic signature dialog requiring password re-authentication, a signature meaning and a legal certification
21 CFR 11.200

Exports: PDF, Excel, CSV, ODM XML and tab-delimited, plus a regulatory endpoint that ships the audit trail with the data.

See it runon your protocol.

Thirty minutes on the real platform. Bring a protocol and we will model it live.

OPEN THE EDC Request a demo

Or email us: jgui@accuratrials.com