InsightEDC for clinical research

Capture, cleaning, signature and database lock — one loop with an immutable audit trail. Data is hosted in Russia.

For sponsors, CROs and investigative sites.

Request a demo How it works

Designed for EAEU GCP, 21 CFR Part 11, Annex 11 and ICH E6. Data hosted in Russia.

Lifecycle

How a study runs

Five stages: from publishing a design version to database lock and export.

DesignThe eCRF is built without a programmerForms, visits and edit checks in the builder; preview and version review before publishing.
CaptureChecks run at the moment of savingErrors surface at entry, not a month later in a data manager’s report.
CleaningA query with an owner and a due dateSome are raised by edit checks, some by hand — by the monitor or the data manager.
SignatureSigning with re-authenticationEditing signed data withdraws the signature: coverage is recomputed.
LockAn export reproducible bit for bitHierarchical locks and a database snapshot you can produce again.

Study matrix: subjects in rows, visits in columns, cells showing entry, queries and locks — Study matrix: entry, queries and locks for every subject and visit.

Study matrix: subjects in rows, visits in columns, cells showing entry, queries and locks — Study matrix: entry, queries and locks for every subject and visit.

Statuses

Four status axes instead of one field

Entry, verification, signature and lock change independently of one another.

A form in the X7 Insight casebook: the status bar shows completion, SDV, an open query and the signature — A form’s status bar in the casebook.

A form in the X7 Insight casebook: the status bar shows completion, SDV, an open query and the signature — A form’s status bar in the casebook.

ALCOA++

A journal that cannot be rewritten

Who changed what and when, the before and after values, and why. No application path can edit without a trace.

The audit journal in X7 Insight: a row is expanded — before/after values, the actor and the hash chain — The journal in the product: before/after, actor, reason and the hash of every record.

The audit journal in X7 Insight: a row is expanded — before/after values, the actor and the hash chain — The journal in the product: before/after, actor, reason and the hash of every record.

Roles

Who does what in the system

Access is computed from access policies, not job titles. Each role’s day is covered in the docs.

Site coordinator (CRC)

Enrols subjects, enters data and answers queries.

Monitor (CRA)

Verifies source data and casebook cleanliness.

Data manager (DM)

Owns the rules, the locks and database closure.

Investigator (PI) and QA

Signs the data and answers for the study before an inspection.

Regulatory context

The rules the core is designed for

EAEU rules and the Anglo-Saxon canon in one core.

EAEU GCP Rules: audit trail, roles and access scopes
EAEU GMP · Annex 11: a validatable system with a change log
21 CFR Part 11: electronic signatures with re-authentication and meaning
EU GMP Annex 11: access control, backups and data integrity
ICH E6: source data, SDV and sponsor oversight
ALCOA++: attributability and immutability of every record
CDISC ODM · Dataset-JSON: standard export formats, a reproducible snapshot

How it is built — in the documentation: Audit trailElectronic signaturesBlinding and data protectionInspection packet

Demo

Request a demo

We show the full loop on a demo study — from eCRF design to database export.

We reply within three business days

Not a fan of forms? Email us: info@x7insight.ru