What is AccuraTrials?

AccuraTrials is the intelligence layer for clinical trials: a semantic and ontology model of the study, built on CDISC USDM and OpenStudyBuilder, that a protocol is read into. From that model the platform drafts eCRFs, compiles plain-language rules into tested edit checks and derives the visit schedule, with every output citing the protocol clause behind it. Electronic data capture built to 21 CFR Part 11 runs on top of the same model.

How does AccuraTrials reduce build times?

AccuraTrials reduces build times by generating eCRF drafts directly from the protocol model rather than from a vendor ticket, and by compiling plain-English validation logic into versioned deterministic rules, all of it for human review before activation.

How does AccuraTrials support inspection readiness?

The evidence is written while the work happens rather than assembled afterwards: edit checks catch anomalies before a form is saved, every change carries its reason, and AI-assisted audit review surfaces patterns in audit activity, such as missing change reasons or repeated late edits, while there is still time to act on them.

Is AccuraTrials 21 CFR Part 11 compliant?

Part 11 compliance is something a sponsor demonstrates for its own system rather than a badge a vendor holds, so the honest answer is that AccuraTrials is built to support it from the ground up. Every electronic signature requires credential re-authentication, and every data change writes to a hash-chained, tamper-evident audit trail with timestamp, user, prior value, new value, and reason.

How long does study setup take with AccuraTrials?

AccuraTrials accelerates study setup. The AI protocol parser generates eCRF drafts from a protocol PDF in minutes for your review, and the 8-tab study wizard handles sites, visits, randomization, and permissions in a single session. Launch timing depends on your review and validation process.

Who builds and amends the study, the sponsor or a vendor?

The study team does. The AccuraTrials Form Builder, Validation Rule Builder and Branching Logic editor are visual interfaces with no XML and no scripting in them, and the AI Rule Suggester proposes edit-check logic from a constraint described in plain English for a person to approve. Amendments are deployed by the team running the study rather than through a vendor change order.

Who is AccuraTrials for?

AccuraTrials is built for sponsors running a program of studies, contract research organizations (CROs) running studies for many sponsors, and biotechs running a first trial, across Phase I to Phase IV and observational designs.

What export formats does AccuraTrials support?

AccuraTrials supports PDF, Microsoft Excel, CSV, ODM XML (CDISC standard), and tab-delimited export. AccuraTrials includes a dedicated regulatory export endpoint for FDA and EMA submission packages with complete audit trails.

How does randomization work in AccuraTrials?

AccuraTrials supports stratified randomization with configurable stratification factors and blinded study arms, with an unblinding workflow for when a treatment assignment must be revealed. AccuraTrials RTSM/IRT kit and shipment tracking is integrated.

Where is AccuraTrials based?

AccuraTrials is based in Madison, Wisconsin, USA. It was founded in 2025 by co-founders Bhuwan Sai Kosuru (CEO) and James Gui (CTO) to build the semantic and ontology layer that lets AI work on clinical trials traceably enough for a regulator to review.

Productsfour lines

One model. Four systems that run on it.

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

Book a walkthrough How the model is built

Indexthis page

01Accura CortexThe intelligence layerThe product
02Accura StudioProtocol to study buildShipping
03Accura OSOne model, every systemIn build
04AccuraTrials EDCWhere the model executesLive in a paid Phase I trial

Cortex01 / 04

Accura Cortex

The product

Cortex reads a protocol and turns it into a semantic, machine-readable model of the study: every concept bound to a standard term, every fact chained back to the clause that authorized it. Everything else on this page is what that model can do once it exists.

protocol ACC-P1-001 /model USDM 3.0 /rev 14

Protocol

§1.3§6.2§8.1§9.4§10.2

Concepts

Forms

Rules

Audit

§8.1.9RulesGAP-0007The protocol states a creatinine limit with no unit. Nothing is generated for an ambiguous clause.Human decision required before this rule exists

ModelledApprovedIn reviewGapHover or select any block to read its source.

Ingest: Protocol, amendments, study specifications and SOPs go in as documents. Nothing enters the model without a pointer back to a specific line in one of them.
Resolve: Concepts bind to CDISC USDM structures and controlled terminology, so “SBP”, “systolic” and “blood pressure (systolic)” resolve to one thing instead of three.
Cite: Every generated artifact carries the clause that authorized it. An output that cannot name its source is rejected before it reaches a study.
Gap: An ambiguous clause produces a labelled gap that waits for a person. The model does not guess in order to fill a hole.
Version: An amendment is a diff against the previous model, not a re-read. You can see what changed and every downstream artifact it touched.

Studio02 / 04

Accura Studio

Shipping

Study build on top of the model. Studio turns an approved model into the things a study actually needs: forms, visit schedules, edit checks and branching logic. Each one stays attached to the clause it came from.

Forms: eCRFs generated from the model, with PHI designation, calculated fields, and a versioned template library you can fork.
Checks: Describe a constraint in plain English and get the field, operator, value and outcome back as a proposal. Approve it and it compiles to a versioned deterministic rule.
Branching: Skip and branching logic derived from the protocol’s own conditions rather than typed in by hand for each form.
Sign-off: Section by section review before anything goes live. Nothing reaches a study on the model’s authority.

The AccuraTrials branching and skip logic editor listing nine typed fields on a Lab Review form with the rule attached to each — **Branching logic on a generated form**Accura Studio

OS03 / 04

Accura OS

In build

The connective layer. One approved model is pushed to every connected system, so an amendment lands once instead of being re-typed into each vendor console and drifting apart mid-study. Here is exactly how far it goes today.

AccuraTrials EDC: Live
eConsent: Prototype
ePRO / eCOA: Prototype
Labs: Prototype
Safety: Prototype
RTSM / IRT: Roadmap
Imaging: Roadmap
CTMS / eTMF: Roadmap

Prototype means it runs against the model in our own environment and has not been through a customer study. Roadmap means it is designed and not built. We would rather say that than call all eight of them live.

EDC04 / 04

AccuraTrials EDC

Live in a paid Phase I trial

Data capture built to 21 CFR Part 11, running directly on the protocol model, so a deviation is flagged against the actual clause rather than against a rule somebody configured by hand last quarter. It is the proof that the layer above it holds up in a real study.

Capture: Forms with live edit checks, queries raised in place with a full conversation thread, and source data verification built into the workflow.
Subjects: Per-site scoping, visit schedules taken from the model, and overdue or incomplete state visible on every subject record.
Part 11: Credential re-authentication on every signature, a hash-chained, tamper-evident audit trail, and an automated Part 11 test suite that runs against all of it.
Export: PDF, Excel, CSV, ODM XML and tab-delimited, plus a regulatory endpoint that ships the audit trail alongside the data.

An AccuraTrials eCRF for vitals and assessment showing branching logic, required fields and a resolved query on the heart rate value — **eCRF with a resolved query in place**Vitals & Assessment

A subject record in AccuraTrials showing enrollment details and a visit timeline with per-visit form completion and overdue flags — **Visit schedule from the model**Subject record

The AccuraTrials audit log listing events with category, actor and timestamp for every action — **Tamper-evident audit trail**21 CFR 11.10(e)

The AccuraTrials electronic signature dialog requiring password re-authentication, a signature meaning and a legal certification — **E-signature, credential re-auth**21 CFR 11.200

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See it run on your protocol.

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

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