The trial,running on the model.
Forms, checks and the visit schedule come out of the study model, not a vendor queue. After go-live, every value is still read against the protocol.
Live checks
A clause becomes a check.Try it.
Drag the value. The rule the protocol set answers as you type.
“Vital signs are recorded at every visit, including systolic blood pressure (60 to 200 mmHg).”
RULE-0341 v1 approved by a person · versioned · deterministic
SavedInside the range the protocol set.
Save blockedOutside 60–200 mmHg · §6.2.1 cited at the field.
After go-live
The protocolkeeps answering.
Caught against the clause.
A visit outside its window arrives with the section that set the window.
An amendment states its impact.
It is a diff against the model, counted before anyone accepts it.
The record replays.
Who, what, when and under which clause, months later, without asking us.
The real thing
Two screens,not renders.
Captured from the platform as it ships, on synthetic demonstration data.
The checklist
And everything an EDCis expected to do.
- RandomizationStratified, blinded, controlled unblinding, kit tracking
- QueriesFrom a failed check or by hand · routed, threaded, escalated
- Source data verificationForm and field level, remote, with a verification log
- Double entrySide-by-side adjudication for critical data
- Medical codingMedDRA and WHODrug against controlled terminology
- Electronic signaturesCredentials re-entered, bound to the version signed
- LocksReadiness check, freeze, sign, lock
- ExportPDF, Excel, CSV, ODM XML, audit trail attached
FAQ
EDC software,answered plainly.
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.
See the build happenon your protocol.
Thirty minutes on the real platform. Bring a protocol and we will model it live.
Or email us: jgui@accuratrials.com