What is AccuraTrials?

AccuraTrials is an AI-native Electronic Data Capture (EDC) with a built-in AI developer. It reduces study build times from months to days by generating eCRFs from protocol PDFs and suggesting validation rules from plain English. Full 21 CFR Part 11 compliance with no programmer dependency.

How does AccuraTrials reduce build times?

AccuraTrials reduces build times by using AI to generate eCRF drafts from protocol PDFs in minutes and suggest validation logic from plain-English descriptions in seconds — all for human review before activation.

How does AccuraTrials support inspection readiness?

AccuraTrials supports inspection readiness with an AI Copilot that catches data anomalies in real-time before forms are saved, and an Audit Trail AI that scans millions of log entries to surface risk patterns that manual monitoring misses — reducing the documentation gaps that lead to inspection findings.

Is AccuraTrials 21 CFR Part 11 compliant?

Yes. AccuraTrials is built for 21 CFR Part 11 compliance. Every electronic signature requires credential re-authentication. Every data change writes to an immutable, 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.

Does AccuraTrials require a dedicated EDC programmer?

No. AccuraTrials is entirely no-code. The AccuraTrials Form Builder, Validation Rule Builder, and Branching Logic editor are all visual interfaces. The AccuraTrials AI Rule Suggester lets you describe a constraint in plain English and it proposes the edit check logic automatically.

Who is AccuraTrials for?

AccuraTrials serves academic medical centers, biotech startups, contract research organizations (CROs), pharmaceutical sponsors, and clinical research sites running Phase I through Phase IV and observational studies.

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, sealed allocation lists, and an emergency unblinding workflow with credential re-authentication and audit capture. AccuraTrials RTSM/IRT kit and shipment tracking is integrated.

Where is AccuraTrials based?

AccuraTrials is based in Madison, Wisconsin, USA. AccuraTrials was founded by James Gui to make enterprise-grade clinical trial EDC technology accessible to research teams of all sizes.

Request a Demo

AccuraTrials

30-minute call. Bring your hardest protocol. We'll show you how all four AI systems — Build, Validate, Monitor, Audit — handle your exact study type.

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No commitment required

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Technical questions welcome

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Compliance docs available on request

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Response within 24 hours

Or reach out directly

jgui@accuratrials.com

📍 Madison, Wisconsin

James Gui

Founder & CEO · AccuraTrials

AccuraTrials

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