Overview
An EDC system for clinical trials
One loop from publishing the design to database lock — with an immutable audit trail. Data is hosted in Russia.
What EDC is
EDC (electronic data capture) replaces paper case report forms: sites enter study data into electronic ones (eCRFs), while cleaning, verification, signatures and database lock happen in the same loop.
What one loop contains
eCRF design in the builder, entry along the visit matrix, edit checks at the moment of saving, queries, risk-based source data verification (SDV), electronic signatures, locks by scope and reproducible export.
What it stands on
Four independent record status axes — entry, verification, signature, lock. An immutable audit trail with a cryptographic hash chain. Policy-based access only: any deny wins, the default is denial.
Who it is for
For sponsors, contract research organizations and investigative sites.
Next — in the documentation: Introduction to the platformVisit matrix
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