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Where neuroscience measurement meets regulatory strategy

Cerebral Innovations LLC is the company behind NeuroQuantix and FaceWise. Led by a clinical trial subject matter expert, we combine precision digital measurement technology with deep endpoint consulting expertise, serving global CNS clinical programs that demand more from their endpoints and their strategic advisors.

What drives our work

CNS clinical trials have a measurement problem. The assessment tools used in most neurological and psychiatric trials were developed decades ago. They rely on subjective observer ratings, operate at low resolution, and were never designed to detect the subtle treatment effects that modern therapeutics produce.

The consequence is real: clinical programs fail not because the therapeutic does not work, but because the endpoints cannot see that it works. This wastes years of development time, hundreds of millions in investment, and most importantly, delays treatments reaching patients who need them.

We started Cerebral Innovations to close this gap. By combining precision digital measurement technology with deep endpoint consulting expertise, we help sponsors build clinical programs where the measurement strategy is as sophisticated as the science behind their therapeutic.

Our Approach

01
Understand the Therapeutic
What is your drug designed to do? What clinical signal should it produce?
02
Map the Global Regulatory Path
What will FDA, EMA, and Health Canada expect to see? What precedent exists in your indication?
03
Design the Measurement
Which endpoints can detect your treatment effect with the sensitivity needed for your trial design?
04
Build the Infrastructure
Rater training, central committees, quality monitoring, and data collection systems that protect data integrity.
05
Support Through Submission
Endpoint narratives, regulatory documentation, and expert testimony for the full development lifecycle.

What We Stand For

Measurement Precision

We believe that better measurement drives better clinical decisions. Every product and service we offer is built on the principle that precision in neurological assessment is not optional.

Regulatory Rigor

Clinical measurement exists within a global regulatory framework. We design everything we build with acceptance by FDA, EMA, and Health Canada as a core requirement, not an afterthought.

Early Engagement

The highest-impact decisions in clinical development happen in the earliest stages. We engage early because correcting measurement strategy mid-program costs orders of magnitude more than getting it right from the start.

Scientific Integrity

We recommend what works, not what sells. Our consulting advice is grounded in published evidence, regulatory precedent, and firsthand experience with what survives the scrutiny of regulatory review.

Meet the founder

David McLaughlin — Founder & CEO, Cerebral Innovations LLC

David McLaughlin

Founder & CEO

Cerebral Innovations LLC

David McLaughlin is a clinical trial subject matter expert with hands-on experience across 40+ CNS clinical trials spanning essential tremor, Parkinson disease, Alzheimer disease, Huntington disease, ALS, epilepsy, psychiatric disorders, and rare neurological conditions. His trial experience covers Phases 1 through 4 across FDA, EMA, and Health Canada regulatory jurisdictions.

He founded Cerebral Innovations to address a persistent gap in clinical development: the mismatch between modern therapeutics and the decades-old measurement tools used to evaluate them. His work combines precision digital biomarker technology with strategic consulting for sponsors designing endpoint strategies for global regulatory submissions.

David is a published co-author of a scoping review in Movement Disorders Clinical Practice that mapped the evidence base across 120 studies of digitized spiral analysis. That review identified the standardization gaps that NeuroQuantix is designed to address.

40+
Clinical Trials
120
Studies Reviewed
5
Regulatory Jurisdictions
23
Neurological Conditions

Key Opinion Leader network

Clinical development decisions are stronger when informed by the physicians and researchers who treat these conditions every day. Cerebral Innovations maintains relationships with Key Opinion Leaders across neurology, movement disorders, and CNS clinical development.

Our KOL network, with connections across the Movement Disorder Society and leading academic centers, accelerates protocol design, site selection, endpoint validation, and regulatory strategy, giving your program access to the domain expertise that shapes how clinical evidence is interpreted by regulators and the medical community.

Movement Disorders

ET, PD, dystonia, DBS programming

Neurodegenerative Disease

AD, MCI, HD, PSP, MSA

Clinical Trial Design

Protocol, endpoints, statistics

Regulatory Science

FDA and EMA advisory experience

Digital Biomarkers

Sensor validation, COA development

Rare Disease

Gene therapy, natural history studies

Publications & Research

Movement Disorders Clinical Practice · 2025; 12(11): 1742–1755

Clinical Applications and Measurement Properties of the Digitized Archimedes Spiral Drawing Test

Wang S, Schwirtlich T, McLaughlin D, Beestrum M, Heinemann AW

Scoping review of 120 studies mapping the evidence base for digitized spiral analysis as a clinical outcome measurement instrument. The review identifies standardization gaps that NeuroQuantix is designed to address.

Frequently Asked Questions

Who is behind Cerebral Innovations?

Cerebral Innovations LLC was founded by David McLaughlin, a clinical trial subject matter expert with hands-on experience across 40+ CNS clinical trials spanning essential tremor, Parkinson disease, Alzheimer disease, Huntington disease, ALS, epilepsy, and rare neurological conditions. His trial experience covers Phases 1 through 4 across five global regulatory jurisdictions.

What products does Cerebral Innovations offer?

Two precision digital neuroscience assessment platforms. NeuroQuantix extracts 397 kinematic metrics from a brief spiral drawing assessment for movement disorder trials. FaceWise measures sleep-dependent memory consolidation through AI-administered overnight delayed recall for Alzheimer and cognitive decline trials.

Where is Cerebral Innovations located?

Cerebral Innovations LLC is headquartered in St. Petersburg, Florida. The company serves pharmaceutical sponsors, biotechnology companies, CROs, and academic research institutions worldwide across five regulatory jurisdictions.

What is Cerebral Innovations' approach to digital endpoints?

Evidence-based and regulatory-focused. Every product is grounded in published peer-reviewed literature with full citation provenance. Diagnostic rules use deterministic logic rather than opaque machine learning. The approach starts with the clinical question and works backward through regulatory requirements.

What consulting services does Cerebral Innovations provide?

Endpoint consulting, central rater committee design and implementation, regulatory strategy for digital health technologies and COA/DDT qualification, and general CNS clinical consulting. All services draw on direct experience across 40+ CNS clinical programs.

Let us show you what precision looks like

Whether you are planning a first-in-human study or optimizing a Phase 3 endpoint strategy, we would welcome the conversation.

Get in Touch