Why Nuqleus
Upstream of everything you already own.
Nuqleus is the protocol execution intelligence layer that converts approved protocol requirements into site-ready visit workflows, applies real-time guardrails during execution, and gives sponsors visibility into preventable risk before data reaches the EDC.
Upstream of your stack
From the protocol document to a guided visit.
The distinction
A layer, not another platform.
CRIO, Florence, RealTime, and Advarra OnCore all market integrated trial platforms that guide source-data collection and documentation. Nuqleus does something upstream of that: it guides protocol execution before and around data capture, and stays system-agnostic on purpose.
A layer, not a platform to migrate onto.
Nuqleus adds a layer above the systems a site already runs — it is not somewhere to move data or workflows onto. Nothing already in place has to change for Nuqleus to start guiding execution.
Execution, not documentation.
CRIO and its peers guide how source data gets captured and documented, inside an eSource or CTMS environment. Nuqleus guides protocol execution — the sequence, the timing, the decisions — before and around that capture, and stays out of the way of whatever system a site already uses to document it.
The protocol itself, not a paraphrase of it.
Every visit, procedure, and timing window is extracted from the protocol document, then reviewed line by line by clinical research professionals before a site ever sees it. Nuqleus drafts, humans approve. Amendments lock as canonical versions, so nobody executes a stale one.
Guidance that preserves clinical judgment.
A protocol-aware sequence guides the intended order and flags exceptions — but a clinician can proceed with documented justification. Nuqleus surfaces risk while corrective action is still possible; it does not overrule the clinician.
A deliberately small data footprint.
No source data, no e-signatures, and no subject record beyond the number the site already assigns — no name, no date of birth, no identifiers.
Works with what you have
Keep the systems you already use.
Nuqleus is system-agnostic and sits upstream of the platforms you already run. It does not capture source data, manage the trial, or ask you to migrate anything.
- EDC
- CTMS
- eSource
- eRegulatory
- Identity provider
What we can evidence
Stated plainly, and no further.
Nuqleus writes every protocol-relevant action — a task completed, a guardrail triggered, a deviation recorded or resolved — into an append-only trail with user, timestamp, and before-and-after state. That is evidence of documented execution. It is not, on its own, regulatory compliance or inspection readiness, and we do not claim it as either. No completed pilot exists yet, so nothing on this site is stated as a measured result.
See where Nuqleus fits above what you already run.
Tell us what your site or sponsor org runs today — Nuqleus sits upstream of it, not on top of it.