Where neuroscience measurement meets regulatory strategy

Cerebral Innovations LLC is the company behind NeuroQuantix and FaceWise. We exist at the intersection of clinical neuroscience, precision measurement technology, and regulatory science, bringing specialized expertise to CNS clinical programs that demand more from their endpoints.

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 Regulatory Path
What will the FDA 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 regulatory framework. We design everything we build with FDA acceptance 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.

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