AccuraTrials
The AI-native EDC that builds, validates, monitors, and audits your trial for you. From protocol PDF to clean clinical data — without a single programmer.From protocol to clean clinical data — without a programmer. The AI-native EDC that builds, validates, monitors, and audits your trial for you.
Four AI systems work together: Build reads your protocol and drafts complete eCRFs. Validate turns plain-English rules into tested edit checks. Monitor watches every data point for anomalies, deviations, and missing values. Audit reviews audit activity and study data so you see risk before an inspector does. 21 CFR Part 11 compliant. Same-day amendments. No vendor change orders. Four AI systems: Build drafts eCRFs from your protocol. Validate turns plain English into edit checks. Monitor watches every data point. Audit reviews trail activity for risk. 21 CFR Part 11 compliant. No vendor change orders.
Launch in days, change anything yourself,
and never wait on a programmer.
Real outcomes for the people who actually run the study — coordinators, data managers, and PIs. Here's what changes the day you switch to AccuraTrials.Real outcomes for the people who run the study — here's what changes when you switch.
Upload your protocol and the AI drafts your visits, forms, fields, and branching logic. You refine everything in a visual editor and go live in days using the 8-tab study wizard — no EDC programmer, no statement of work, no months-long build.
Update forms, visit schedules, and validation rules yourself and version them the same day — no vendor change order, no reprogramming, no waiting on a ticket. In legacy EDC, a single amendment runs $141K–$535K and takes ~260 days to roll out.
Type a rule the way you'd say it — "onset date can't be before consent" — and the AI writes the field, operator, value, and outcome. Preview it live, then apply. What used to take a programmer weeks now takes seconds, and a human always approves.
Describe your rule in English.
The AI writes the edit check.
"Age must be 18 or older." "Onset date can't be before consent." Type what you need. The AI writes the edit check — field, operator, value, outcome. Review it. Click Apply. Done."Age must be 18+." Type it. The AI writes the edit check. Review. Apply. Done.
- Plain English → edit check logic — AI proposes field, operator, value, and outcome in one step
- 4 outcomes — Block Save, Auto-Query, Warning, or Conditional Required — per rule
- Live preview — See the rule fire in real-time as you build it
- No programmer, no vendor ticket, no change order — Amendments deploy the same day
Drop in a protocol.
Get your study back.
No more weeks of manual spec writing. Upload a protocol PDF — the AI reads it and drafts your visits, forms, fields, branching logic, and data dictionary. You refine it with a visual editor. That's it.Upload a protocol PDF. The AI drafts your visits, forms, fields, and branching logic. You refine it. That's it.
- Full eCRF draft — Visits, forms, 50 field types, data dictionary — not a blank canvas
- Branching logic included — Skip logic, form links, and conditional display, suggested from protocol text
- You stay in control — Review, tweak, and approve everything in a visual editor before go-live
An AI that watches
every data point you enter.
Standard validation catches what you code for. The AI Copilot catches what you didn't think to code — missing data, out-of-window visits, impossible vitals combinations, and protocol deviations — flagging them for human review before they compound into inspection findings.The AI Copilot catches what standard validation misses — flagging anomalies, missing data, and protocol deviations for human review before they compound.
- Catches the impossible — 4'10", 400 lbs? Flagged. Onset before consent? Flagged. All for your review.
- Built-in chatbox — Sites ask questions, get protocol clarifications, and resolve queries without leaving the form.
- Auto-drafts queries — Flagged anomalies get discrepancy notes drafted and routed to SDV, ready for monitor review.
Scan a source document.
The form fills itself.
Sites still work from paper. Magic Fill lets a coordinator photograph or upload a source document — OCR reads it, pre-fills the actual patient eCRF, and shows each extracted value highlighted on the source page so you can verify before anything is saved.Photograph a paper source document. OCR pre-fills the patient eCRF, with every value traceable to the page. You review, then save.
- Real eCRF, not a staging screen — extracted values land in the patient's actual form for field-by-field review
- Every value traceable — click a field to see where on the source page the value came from
- Human-approved, audit-logged — nothing saves without review; the source document stays attached as evidence
The FDA demands transparency.
We record everything.
Using AI in clinical trials requires trust. Every AI suggestion, prompt, and user decision is logged in the immutable audit trail — what was suggested, what was accepted, what was modified, and by whom. Human-in-the-loop is enforced. Everything is inspection-ready.Every AI suggestion, acceptance, and modification is logged in the immutable audit trail. Human-in-the-loop is enforced. Everything is inspection-ready.
E-signature credential re-auth · Hash-chained immutable audit trail · Automated Part 11 compliance test suite
The AI's logic, prompts, and suggestions are logged permanently. If the AI suggests a rule, the audit trail proves a human approved it.
Full subject lifecycle traceability · SDV workflow · Protocol amendment audit capture
Idle timeout (10 min warning / 20 min logout) · Device fingerprinting · 39 granular permissions
PHI field designation per eCRF · Role-scoped access to subject data · Full access audit trail
Configurable retention policies · Data access audit · Per-site user access controls
"Every data modification—whether by a site user, a monitor, or the AI Copilot—is logged with timestamp, user, reason, and prior value. Records cannot be altered after write."
AccuraTrials brought enterprise EDC capabilities within reach for our organization. The compliance features, ease of use, and no-code configuration were critical for our research operations at Phoenix-Aid.
Built by people who've run trials —
for the people who run yours.
Made for the people doing the work
AccuraTrials was founded to fix a problem our team lived firsthand: running a study shouldn't require a dedicated programmer — or a six-figure change order every time the protocol moves.
We help you get live
Hands-on migration, first-study setup, and team training — with direct access to the people who build the product. Questions answered within 24 hours, not buried in a ticket queue.
Your data stays portable
CDISC-aligned data models, CDASH field libraries, ODM XML export, and FHIR-ready EHR integration mean your data interoperates with the rest of your clinical research stack — and is always yours to take with you.
See the platform
your team will actually use
Four AI systems — Build, Validate, Monitor, and Audit — work together inside one 21 CFR Part 11 compliant EDC. Here's what that looks like in practice.
Everything you need to know about
AI-native EDC
What is an AI-native EDC?
An AI-native EDC is electronic data capture software built around artificial intelligence from the ground up, rather than a legacy platform with AI features bolted on. In a traditional EDC, a programmer translates your protocol into electronic case report forms (eCRFs), hand-codes every validation rule, and repeats that work for each protocol amendment. An AI-native EDC like AccuraTrials reads your protocol PDF and drafts the eCRFs, visit schedule, and branching logic automatically; turns plain-English rules such as "age must be 18 or older" into tested edit checks in about 30 seconds; and continuously monitors incoming data for anomalies, missing values, and protocol deviations. A human reviews and approves every AI suggestion, and every action is recorded in an immutable 21 CFR Part 11 audit trail. The result: studies that once took months to build go live in days, without a dedicated EDC programmer.
AccuraTrials key facts
- Build speed: go from a protocol PDF to a live study in days, not the 8–12 weeks a legacy build takes.
- Self-service amendments: update forms, visit schedules, and rules yourself and deploy the same day — no vendor change orders.
- Plain-English validation: describe an edit check in words and the AI proposes tested logic in about 30 seconds for your approval.
- Compliance built in: 21 CFR Part 11, HIPAA, GDPR, and ICH E6(R2) GCP aligned, with an immutable audit trail and e-signatures that require credential re-authentication.
- No-code by design: a visual form builder with 50 field types, branching logic, and calculated fields — no programmer required.
- One platform: EDC, randomization and RTSM, MedDRA and WHODrug coding, source data verification, query management, and ODM XML (CDISC) export.
- Magic Fill: photograph a paper source document and OCR pre-fills the patient eCRF — you review each value against its highlighted source before anything saves.
- Patient-facing: eConsent with versioned documents and a signing workflow, plus ePRO patient-reported outcomes through a patient portal.
- Connected: FHIR-ready EHR integration for systems such as Epic and Cerner.
- Built for: sponsors, CROs, biotech, and academic medical centers running Phase I–IV and observational studies.
AccuraTrials vs. legacy EDC vs. spreadsheets
| Capability | AccuraTrials | Legacy enterprise EDC | Spreadsheets / paper |
|---|---|---|---|
| Time to first study | Days — AI drafts eCRFs from your protocol | 8–12 weeks of vendor build | Fast to start, but no validation or audit trail |
| Protocol amendments | Same day, in a visual editor — no change order | $141K–$535K to implement (Getz et al., Tufts CSDD) | Manual rework with high error risk |
| Validation rules | Plain English → tested edit check in ~30s | Weeks of programmer time per rule | None — errors caught late, if at all |
| 21 CFR Part 11 audit trail | Built in, immutable, on by default | Available, often at added cost | Not compliant |
| Dedicated EDC programmer | Not required | Required for most changes | Not applicable |
| Pricing | Usage-based and transparent | Six-figure annual enterprise contracts | Low cost, high compliance risk |
How fast can you launch a study?
With AccuraTrials, most teams go from a protocol PDF to a live study in days rather than the 8–12 weeks a legacy EDC build typically takes. You upload the protocol and the AI drafts your visits, forms, fields, and branching logic. You refine everything in a visual, no-code editor and configure sites, randomization, and user permissions in the 8-tab study wizard — usually in a single working session. Because there is no programmer in the loop, you are not waiting on a vendor queue or a statement of work. Exact go-live timing depends on your own review and validation process, but the build itself is measured in days, not months.
Do you need a programmer or a vendor change order?
No. Every part of AccuraTrials that a legacy EDC would hand to a programmer — the form builder, the validation-rule builder, and the branching-logic editor — is a visual, no-code interface. The AI Rule Suggester lets you describe a constraint in plain English and proposes the field, operator, value, and outcome for your approval. When your protocol changes, you update forms, visit schedules, and rules yourself and deploy them the same day. There are no vendor change orders, no per-rule programming fees, and no waiting weeks for a ticket — the people running the study own the entire process end to end.
How does AccuraTrials handle compliance and audit trails?
AccuraTrials is built for 21 CFR Part 11 from the ground up. Every electronic signature requires credential re-authentication and a recorded reason for signing. Every data change writes to an immutable, tamper-evident audit trail capturing the timestamp, user, prior value, new value, and reason. Every AI suggestion is logged with what was proposed, what a human accepted or modified, and by whom, so reviewers can prove human oversight. An automated Part 11 test suite verifies the audit-trail hash chain, signature binding, and access controls, and the platform also aligns with HIPAA, GDPR, and ICH E6(R2) GCP for studies that span regions and protected health information.
Common questions,
direct answers.
If you don't find what you need, email jgui@accuratrials.com directly.
Request a Demo →Your next study doesn't need
an EDC programmer.
30-minute demo. We'll show you all four AI systems working on your exact study type — Build, Validate, Monitor, Audit. Bring your hardest protocol. No commitment.30-minute demo. Bring your hardest protocol. See all four AI systems in action.