Protocol compliance

From an approved protocol to a guided visit.

The protocol arrives as a document. Nuqleus turns it into the sequence, timing, and guardrails a coordinator works through at each visit — reviewed by clinical research professionals before any site sees it.

How it works

Four places Nuqleus keeps the visit on protocol.

01

Nuqleus reads the protocol. Clinical research professionals approve it.

Every visit, procedure, and timing window is extracted from the protocol document, then reviewed line by line before a site ever sees it. Nuqleus drafts, humans approve.

02

The protocol, in the right sequence — with controlled exceptions.

When a coordinator opens a subject visit, every procedure appears as a step in the right sequence and the right timing window, for that exact visit. Nuqleus guides the intended order, flags exceptions, and preserves clinical judgment with documented justification.

03

Risk caught while it's still preventable.

Real-time guardrails flag an out-of-window visit or a missed procedure before it happens — protocol risk identified early, while there's still time to act, not in a post-hoc review.

04

Amendments lock as canonical versions.

An amendment is uploaded, extracted, reviewed, and locked — then each site adopts it for their study, so coordinators always execute the current version rather than a stale printout.

Amendment impact

See which visits and procedures an amendment changes, before it reaches sites.

When a new version is uploaded, Nuqleus pairs it against the current one and shows the operational difference — then shows exactly who it lands on before anything is committed.

A side-by-side difference

Visits and procedures paired old-to-new and marked added, removed, changed, or unchanged — the operational difference, not a document redline.

Uncertain pairings go to a human

Where automatic matching isn't confident, the row is handed to a reviewer to map deliberately. Nuqleus drafts, humans approve.

Impact before commit

A preview per site: how many active subjects and scheduled visits will be regenerated, and confirmation that completed and in-progress visits stay on the previous version. Affected subjects are gated behind re-consent.

See your own protocol operationalized.

Tell us about your study and we'll walk you through it — your protocol, your visits.

Request a demo