An EDC system that shows what comes next
One loop from design publication to database lock: every value has independent entry, query, SDV and signature statuses, every change leaves a trace.
- Design
- Entry
- Cleaning
- Signature
- Lock
The essentials
One loop instead of five systems
eCRF design, entry along the visit matrix, edit checks, queries, SDV, signatures, locks and exports — in one system. No hand-offs between tools and no manual reconciliation.
Statuses are axes, not one field
Entry, SDV, review and coding change independently; signature and lock are computed from coverage. You see what has been done with each value and what is still ahead.
Access comes from policies
Permission × scope: study, site, subject. Any deny on the path wins, the default is deny. There are no “by job title” checks in the code.
The path of a study
- 01DesignBuilder, preview, review and approval of the version before publication.
- 02EntryCasebook along the visit matrix; the check fires on save.
- 03CleaningQueries at the value, SDV from a queue, medical review and coding.
- 04SignatureInvestigator signature with re-authentication over a data snapshot.
- 05LockLocks by scope, a cut-off export and the closeout package.
Questions
Related regulations
How to set it up — in the documentation
Which studies is the system for?
Clinical studies run by sponsors, CROs and sites: single- and multi-centre, including bioequivalence studies — with a module of the same release.
Do sites need to install anything?
No: it runs in the browser. Sign-in by email and password, a second factor by organisation policy.
See also
See the system on your own scenario
We walk through the full cycle on a demo study and answer your validation and hosting questions.