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.

EDCdata capture

The trial, running on the model.

The forms, the checks and the visit schedule come out of the study model rather than a vendor ticket queue. And because the model stays live after go-live, the study keeps answering to it: every value, every deviation and every amendment is read against the protocol itself.

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Capture04 ideas

Four things that follow from capture knowing the protocol.

01Strange data, immediately Not at the next monitoring visit. A value that is implausible for this subject at this visit is flagged as it is typed — against the ranges this protocol defines, and against what the same subject recorded last time, rather than a generic bound.

02Deviations caught against the clause A visit outside its window, a missed assessment, a dose that does not match the assigned arm. The deviation is raised against the protocol section that established the requirement, so the finding arrives with its authority attached instead of as an opinion.

03An amendment states its own impact An amendment is a diff against the study model, so its consequences are visible before it is accepted: which forms change, which visit windows move, which findings are affected, which sites are touched. It is a review, not a change order.

04Audit as replay The audit trail is not an archive to be exported once at the end. It is a record that can be replayed: who changed what, when, under whose authority, and against which clause — months later, without asking us to explain it.

An AccuraTrials eCRF for vitals and assessment with branching logic and a resolved query in place — eCRF with a resolved query in place Vitals & Assessment

Branching logic configured on a generated form in AccuraTrials Studio — Branching logic on a generated form Accura Studio

Alsothe checklist

And the things an EDC is simply expected to do.

Queries — raised by a failed check or by hand, routed, threaded, escalated
SDV — form and field level, remote monitoring, complete verification log
Double entry — side-by-side adjudication for critical data
Locks — readiness check, freeze, sign, lock, export
Signatures — credential re-authentication, bound to the record version signed
Randomization — stratified, blinded arms, controlled unblinding, kit tracking
Coding — MedDRA and WHODrug against controlled terminology
Export — PDF, Excel, CSV, ODM XML, with the audit trail attached

FAQthe questions

EDC software questions.

What does EDC stand for?

Electronic data capture: the software a clinical trial uses to collect, validate, store and export study data, replacing paper case report forms with a system that catches errors at the point of entry.

How fast can a study go live?

Days rather than weeks for most studies, because the protocol drafts the build instead of a specification going into a queue. Review and validation still have to pass before activation — that part is not compressible.

Is it built for 21 CFR Part 11?

It is designed around those controls: a tamper-evident audit trail, electronic signatures with credential re-authentication, role-based access control, session management and data-locking workflows. Part 11 compliance is something a sponsor demonstrates for its own system and use, not a certificate a vendor holds — so what we offer is the machinery and the evidence. The section-by-section mapping is public.

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Nextthe ask

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