Pre-EDC Execution AssuranceSee how The execution layer for clinical protocols.
Nuqleus converts protocol requirements into expert-validated visit workflows and real-time guardrails, helping sites prevent avoidable deviations before data capture.
Watch a protocol become a guided, guarded visit.
Three places Nuqleus works at the moment of execution — not in a post-hoc review.
The approved protocol arrives as a sequenced checklist — and a guardrail flags an out-of-window visit while there is still time to act.
Every visit lands on the calendar with its protocol window — and a visit drifting outside it is flagged and rescheduled back in.
Nuqleus reads the protocol and drafts every visit, procedure, and window — clinical research professionals review each extraction before a site sees it.
The approved protocol arrives as a sequenced checklist — and a guardrail flags an out-of-window visit while there is still time to act.
Every visit lands on the calendar with its protocol window — and a visit drifting outside it is flagged and rescheduled back in.
Nuqleus reads the protocol and drafts every visit, procedure, and window — clinical research professionals review each extraction before a site sees it.
Coordinators run it. The whole organisation feels it.
Nuqleus is designed to reduce preventable deviations, coordinator rework, monitoring findings, protocol interpretation burden, and amendment-related execution risk.
For research sites
Less protocol searching during the visit, and less rework after it.
For sponsors and CROs
Risk visibility earlier than EDC review, without reading every task.
For monitors
Risk-prioritised review instead of reconstructing what happened.
Keep the systems you already use.
- EDC
- CTMS
- eSource
- eRegulatory
- Identity provider
Frequently asked questions.
Everything sites and sponsors ask before bringing Nuqleus into a study. Still curious? Talk to us.
It's the layer that comes before your EDC ever sees a data point. Nuqleus turns the protocol into guided, per-visit checklists with real-time guardrails, so procedures happen in the right order and the right window — at the moment of execution, not in a post-hoc review.
No e-signatures, no source data verification, no data capture. Just getting the visit right.
No. Nuqleus is system-agnostic and sits upstream of the platforms you already run — your EDC, CTMS, eSource, eRegulatory system, and identity provider all stay exactly where they are.
Your EDC still captures the data and your CTMS still manages the trial. Nuqleus guides protocol execution before and around data capture, so what reaches those systems is clean the first time. It does not capture source data or manage the trial itself.
Nuqleus drafts, humans approve. Nuqleus reads the protocol and extracts every visit, procedure, and timing window — then our protocol specialists review each extraction line by line before anything goes live at a site. Nothing a coordinator sees is unreviewed.
The amendment is uploaded, extracted, reviewed, and locked as the new canonical version — then each site adopts it for their study. Coordinators always execute against the current amendment, never a stale printout.
Built for enterprise, secure by design.
Nuqleus runs inside the controls your IT and quality teams already ask about — and holds far less of your data than you'd expect.
Append-only audit trail
Protocol-relevant changes are timestamped into a log no application path can edit or delete.
Enterprise SSO
SAML single sign-on through your existing identity provider.
Tenant isolation
Row-level security on every table — a site reaches its own study data and nothing else.
Role-scoped access
Five defined roles, each reaching exactly the surface their work requires.
Encrypted in transit
TLS on every request, and protocol documents encrypted at rest in private storage buckets rather than behind public URLs.
Minimal subject footprint
No source data, no e-signatures, and no subject identifiers beyond the site-assigned number.
See your protocol operationalized.
Tell us about your study and we'll set up a demo against a protocol you recognise.