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Built for IVD & medical-device studies

Clinical data.
Clear at every step.

From the first visit to data review, give each team a clear next action — with traceable changes and access shaped around their role.

Request a demo See how it works

Electronic data capture for sites, monitors, data managers and sponsors.

RT ClinicaIllustrative workspace · not live data
Example study / Site 01Investigator

My work

What needs your attention today.

Reply to a queryOpen the question and its field context
Review before signingCheck the casebook and outstanding items
Continue data entryReturn to the subject and visit
Audit historyWho changed what, when and why

One connected workflow

Less searching.
More time for the study.

Keep capture, missing data, queries and review connected — without treating them as the same task.

  1. 01 / Configure

    Prepare the study

    Define visits, forms, checks and access. Review configuration before publishing.

    Study setup
  2. 02 / Capture

    Work through the visit

    See the subject and visit in context, with clear field labels and server-confirmed saves.

    Site workflows
  3. 03 / Review

    Resolve the right issue

    Complete missing data in Data quality. Use Queries for questions, replies and resolution.

    Queries & review
  4. 04 / Trace

    Understand each change

    Inspect values, authors and reasons in the audit trail. Export within your permissions.

    Data & exports

A workspace for each responsibility

The same study.
A different daily view.

Role-based workspaces help each team focus. Study and centre assignments determine which records they can access.

PI & site teams

Know what to do next.

Continue visits, complete missing fields and answer queries. Investigators can review signing tasks and authorized audit history.

Explore capture
Monitors / CRA

Review with context.

Move between review items, source-data verification and queries, with the relevant record close at hand.

Explore review
Data managers

Turn issues into action.

Work through data quality, query resolution and study configuration. Keep review and export controls explicit.

Explore data management
Sponsors & auditors

See the evidence you need.

Sponsors follow study progress and reports. Auditors inspect authorized records and their history in a read-only workspace.

Explore oversight

Traceability, in the workflow

A changed value should come with its story.

Open an audit record to see the previous and new value, the author, time and recorded reason. History is read-only and scoped to authorized records.

How data integrity works

Illustrative audit record · synthetic data

Visit date corrected

Previous value
10 Sep 2026
New value
11 Sep 2026
Changed by
Example investigator
Recorded at
12 Sep 2026, 09:15 UTC
Reason
Transcription corrected against the source record.

Built around study responsibilities

Understand the controls.
Decide what fits your study.

Governance, not a shortcut

Explore access controls, signatures and traceability. Regulatory compliance also depends on your study configuration, procedures and validation.

Compliance & security

Human-reviewed configuration

AI can assist with configuration drafts. Study teams review and approve them; it does not make clinical decisions or silently change subject data.

Our approach to AI

See RT Clinica in context

Start with your study's workflow.

Tell us about your visits, sites and team. We will walk through capture, queries, review and traceability with you.

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