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.

Platformclinical trial software

One study. One meaning. Every system still itself.

Research has tolerated split toolchains for decades: one vendor for capture, another for randomization, a third for coding, separate contracts for signature and export. Every seam is a mapping, and every mapping is a place two systems can disagree about the same subject. Here the parts stay distinct — and they read one model.

Book a walkthrough Feature index

Model03 layers

A trial produces three kinds of thing. They have to agree.

Not one database with everything in it. One meaning, which the documents, the decisions and the software all resolve against.

DocumentsThe source of authority Protocol, amendments, study specifications, SOPs. Read once into a machine-readable model instead of re-typed into each system that needs it — and every concept keeps a pointer back to the line it came from.

DecisionsWhat people and the system chose Eligibility, dosing, a deviation, a query, a signature, an amendment. Each one is attributable, timestamped, and tied to the clause that authorized it, which is what makes the record reviewable rather than merely complete.

SoftwareThe parts that execute Generated from the model rather than configured beside it, so there is no mapping step between them and no version of the study that only one system believes in.

Capture — eCRF builder, protocol parser, validation engine
Oversight — queries, source data verification, double entry
Allocation — stratified randomization, blinding, trial supply
Terminology — MedDRA and WHODrug coding
Closure — data locks, e-signature, regulatory export

The product lines these sit inside

Loop04 movements

Build, monitor, amend, prove — and then again.

A study definition that is only used once, at setup, is a document. The same model has to carry the study while it runs, or the software drifts away from the protocol the moment anything changes.

Build: The protocol drafts the forms, the checks and the visit schedule. A person reviews and applies; that act is what puts it live.
Monitor: Entry is read against the protocol, not against generic bounds, so an implausible value or a missed assessment surfaces while it can still be fixed.
Amend: An amendment is a diff against the model that states its own consequences: which forms change, which windows move, which findings are affected.
Prove: Because each of the three movements above wrote its reasons down as it happened, the evidence is a replay of the record rather than a reconstruction at the end.

FAQthe questions

Clinical trial software questions.

What is the difference between EDC and clinical trial software?

EDC software is the data layer: form design, entry, validation and export. Clinical trial software is the wider platform around it, adding randomization, query management, medical coding, source data verification, e-signature and study administration. Both are one product here.

Can this replace several clinical trial vendors?

In most study designs, yes: capture, randomization and supply, queries, coding, SDV, signature, locks and regulatory export are all in scope. For a CTMS or a dedicated safety database, the answer is integration over a REST API rather than replacement — we do not build those and we will not pretend otherwise.

How are protocol amendments handled?

As a versioned change to the study model. Update the forms, fields and affected rules, review the stated impact, then activate the new version. Because every part reads the same model, the change propagates without a mapping exercise between vendors.

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