Drug Development & Trial Analytics

Biomarker analysis, trial-planning statistics and independent model checks for teams developing treatments for brain and age-related diseases.

Who this is for

Teams we help in this field.

Biotech and pharmaceutical R&D teams

You work in neuroscience and need biomarker or imaging statistics you can defend.

Academic translational groups

You are preparing an early-phase study and need an endpoint and a sample size.

CROs and consultants

You need specialist imaging or brain-age statistics alongside your own team.

Audiences we welcome, not a list of clients.

Questions we help answer

What teams in this field ask us.

  • Which imaging or digital biomarker could help select participants for our trial?
  • How many participants do we need for an imaging endpoint?
  • Is our disease-progression or prediction model good enough to rely on?
  • How should exploratory biomarker analyses be pre-specified?
  • What does the published evidence say about AI biomarkers for early Alzheimer's disease?
  • How much does a brain measure change over a year in people like our participants?

What you receive

  • An evidence memo: what the literature supports, and where it is thin.
  • A simulation-based sample-size report: with the assumptions stated and varied.
  • Analysis-plan sections: for exploratory biomarker endpoints, ready for your protocol.
  • A model validation report: discrimination, calibration and external validity.
  • Reproducible code: so your team can rerun every number.
See an example report

Methods we use

The methods specialists ask about.

  • Simulation-based power
  • Mixed models for repeated measures
  • Enrichment analysis
  • Nested cross-validation
  • Calibration
  • External validation
  • MRI morphometry
  • Brain age

Evidence

Published work behind this area.

Drug Discovery Today · 2025

Advancements and challenges in using AI for biomarker detection in early Alzheimer's disease

Reviewed where AI biomarkers for early Alzheimer's disease stand, and their open problems.

Read the paper (external site)

Aging and Disease · 2025

Neuroanatomical Signature of the Transition from Normal Cognition to MCI in Parkinson's Disease

Mapped brain changes as people with Parkinson's disease move from normal cognition to MCI.

Read the paper (external site)

NeuroImage: Clinical · 2019

Bias-adjustment in neuroimaging-based brain age frameworks: A robust scheme

A bias-adjustment scheme for brain-age measures used as study outcomes.

Read the paper (external site)

Boundaries

Our part is the data and biomarker side, not the chemistry. We do not do laboratory or compound-screening work, operate GCP-validated or 21 CFR Part 11 systems, act as statistician of record for a regulated trial, or prepare regulatory submissions. We support planning and exploratory, research-use analyses.

How we handle data

Packages that fit

Start at the right scale.

The same packages and prices on every page. Each starts with a written scope.

Best first step

Research Diagnostic

Fixed priceCAD 495

  • 60-minute video call
  • Two-page risks and next-steps memo
  • Optional 30-minute debrief

Paid in full at booking.

Memo within 5 business days of the call.

Ask about this

Analysis Plan Sprint

Fixed priceCAD 1,250

  • Analysis and validation plan
  • Scoped sample-size or power calculation
  • Methods text or reviewer response

50% to start; 50% on delivery.

Delivery date agreed in the written scope.

Ask about this

Data-to-Results Sprint

FromCAD 3,000

  • Agreed analysis and quality-control log
  • Figures, tables and methods text
  • R or Python code and recorded environment

50% to start; 50% on delivery.

Final price and delivery date agreed after scoping.

Ask about this

Questions

About working in drug development & trial analytics.

Do you work on regulated (GCP) trials?

Only on planning and exploratory analyses outside the validated trial systems. The sponsor's statistician of record remains responsible for the regulated analysis.

Can you sign our NDA?

Yes, before any confidential document or data are shared.

Who owns the code and results?

You do, once the invoice is paid, unless the written scope says otherwise.

Can you work alongside our CRO?

Yes. We agree in writing who owns each analysis, so nothing is done twice.

Can you estimate how much a brain measure changes in a year?

Yes, from published data or your own pilot data, with the uncertainty shown. This number drives the sample size of an imaging endpoint.

How quickly can you start?

After a short call and a written scope. The Research Diagnostic is the fastest way to start: a 60-minute review and a written memo.

Discuss a drug development project.

Start with a short, non-confidential description. We reply with a suggested next step.

Start a project