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 millions of trail entries 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.
These are documented industry figures. AccuraTrials was purpose-built to attack every one of these cost drivers.AccuraTrials was purpose-built to attack these cost drivers.
Legacy EDC: every protocol change means reprogramming, re-validation, retraining. Phase II amendments cost $141K median; Phase III costs $535K median. With AccuraTrials, you update forms and rules yourself — same day, no change order, no vendor ticket.
Every day your study isn't live is lost market exclusivity. Oncology: $840K/day median. Cardiovascular: $1.4M/day. AccuraTrials compresses the build cycle: AI drafts your eCRFs, you refine them, and your team goes live radically faster.
Protocols change. 76% require at least one amendment, averaging 3.3 per study. Implementation takes 260 days average. In a legacy EDC, each one restarts the cost clock. AccuraTrials deploys amendments same-day, no vendor involved.
"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.
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.
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.
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 · Immutable audit trail · Automated Part 11 test harness runs on every build
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 · 28 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.
AccuraTrials was founded to solve a problem its team lived firsthand: clinical trials shouldn't require a dedicated programmer just to build a study.
Featured at the Madison startup ecosystem's premier pitch event, presenting AccuraTrials' vision for eliminating the programmer dependency in clinical EDC systems.
AccuraTrials uses CDISC-aligned data models, CDASH field libraries, ODM XML export, and FHIR-ready EHR integration — ensuring interoperability with the clinical research ecosystem.
If you don't find what you need, email jgui@accuratrials.com directly.
Request a Demo →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.