Neuroimaging Biomarker Strategy

De-risking Brain Biomarkers
Before Trial Decisions Lock

Independent neuroimaging biomarker strategy across the full Phase II chain. The measurement chain behind a brain biomarker is rarely as visible as it appears, even from inside the organisation responsible for governing it — we make that chain legible before protocol and vendor decisions lock it in.

20+

Years CNS imaging

5

CNS domains

3

Working languages

Request a Strategy Call
Luciana Bonnot, PhD — neuroimaging consultant

About

Independent scientific judgment,
before trial commitments harden

With a PhD in Neuroscience and more than two decades in multi-site neuroimaging across neurology and psychiatry, I work at the interface where biomarker science becomes a trial decision. I understand the signal, but also the acquisition, processing, QC, documentation, and governance conditions that determine whether that signal can support a credible endpoint role.

I work independently — no incentive to oversell any infrastructure. Two decades across the full measurement chain means I see what no single internal function is positioned to see. That cross-chain visibility is what programs need before decisions harden.

Based in France · Working internationally in English, French, and Portuguese.

Neuroimaging biomarker strategy

Framing, context of use, and evidence pathways — what claims the data can realistically support.

Early-phase neuroimaging decisions

Feasibility, validation direction, and risk assessment before protocol lock.

Clinical and real-world imaging evidence

Decision-relevant endpoints and meaningful metrics that hold up under regulatory inspection.

Regulatory and device governance

SaMD lifecycle controls, change-control policy, and audit-readiness for imaging pipelines used as trial endpoints.

When This Matters

You do not need more biomarker enthusiasm.
You need a defensible decision.

Many neuroimaging biomarker programs do not fail because the signal is useless. They fail because no one owns the full chain between clinical intent, acquisition reality, processing logic, QC decisions, vendor outputs, and the endpoint claim. I help you close that gap early.

Situation 01

You are before protocol lock

You need to know whether the biomarker role is realistic before the protocol, SAP, vendor scope, and site requirements become expensive to change.

Situation 02

Your teams are not aligned

Clinical, imaging, statistics, regulatory, and vendor teams are using different definitions of what the endpoint must prove, control, and document.

Situation 03

Your measurement chain is not fully visible — even internally

Vendors control the pipeline, core labs own the QC, sites manage acquisition. No single internal role sees across all of them at once. Risks accumulate in the gaps between functions — invisibly, until commitments are already locked.

My role is to translate biomarker complexity into a clear decision: proceed, redesign, limit the claim, or stop before avoidable risk becomes embedded.

Who This Is For

Is this the right conversation for you?

Pharma sponsor

You are building an NdDB endpoint into a Phase II program. You need independent judgment on whether the measurement chain can support the claim — before protocol, SAP, vendor scope, or site requirements lock it in.

Biotech / startup

You are moving an imaging biomarker from research-grade to trial-grade. You need to know what endpoint-grade governance will require — and where your current setup falls short — before commitments are made.

CRO

You manage imaging governance on behalf of a sponsor. A sponsor who arrives with prespecified outputs, locked pipeline requirements, and agreed change control is easier to scope, deliver for, and defend. Independent sponsor-side preparation before engagement reduces your exposure.

Imaging core lab or neuroimaging platform

You provide the pipeline or the processing infrastructure. A sponsor who understands what endpoint-grade governance requires before engaging you arrives with better requirements, fewer scope changes, and less mid-study auditability pressure.

If the chain between clinical intent and trial endpoint is not yet fully visible — this is the right conversation.

How to Work Together

Start small, clarify fast, scale only if useful

All engagements are structured around the NdDB Readiness Map — a framework for evaluating whether an imaging-derived biomarker program is ready to become a governed trial endpoint.

Entry

Scientific Readiness Scan

A focused review of your biomarker idea, trial role, available data, and obvious failure points.

Best for: teams deciding whether the concept is worth developing further.

Core

NdDB Readiness Review

A structured review of endpoint role, acquisition feasibility, pipeline maturity, change-control needs, and vendor visibility.

Best for: Phase II programs before protocol, SAP, or vendor scope is locked.

Advisory

Embedded Scientific Advisor

Ongoing independent input across biomarker governance, evidence alignment, vendor outputs, and decision documentation.

Best for: sponsors needing senior scientific judgment without building a new internal function.

The Framework Behind the Work

NdDB Readiness Map — Phase II CNS Drug Development

Six governance dimensions. From acquisition to regulatory posture.

Explore the Framework →

Contact

Bring me in before the decision hardens

Early, independent judgment around neuroimaging and brain biomarkers can prevent costly late-stage rework. Share your program context, the intended biomarker role, and where the uncertainty sits — I’ll reply within 48 hours.

  • ✓ Confidentiality assured
  • ✓ NDA available on request
  • ✓ Response within 48 hours
lucianabonnot.github.io — Full Profile linkedin.com/in/bonnot-luciana