ClarityAccessHub

For Manufacturers

The operating counterparty for anti-amyloid therapy.

ClarityAccessHub primarily partners with manufacturers through service agreements for clinical coordination and separate data agreements for longitudinal real-world evidence — each structured to support compliant operational collaboration and real-world treatment coordination at network scale. Manufacturers don't need another advisor. They need an operating counterparty that converts drug approval into treated patients, routable sites, registry compliance, and real infusion throughput. That's what ClarityAccessHub is built to do.

How We Partner

Capabilities, not boilerplate.

ClarityAccessHub's manufacturer partnerships are organized around two distinct capability streams. The specific commercial structure for any partnership is negotiated to match your templates and compliance posture — built on the established frameworks your commercial and legal teams already work within.

Capability Stream 1

Clinical Coordination Services

Operationalizing the four-pillar workflow at network scale

What it covers

ARIA surveillance coordination across the network, prior authorization management, CMS NCD registry submission, REMS compliance, referral routing and AIC matching, therapy coordination hub, and patient support navigation.

How it is typically structured

Service contracts — commonly referred to as Enhanced Service Contracts — that compensate ClarityAccessHub for documented clinical coordination work at network scale. Fair market value analysis supports each engagement. Compliance posture aligns with manufacturer-preferred templates.

Capability Stream 2

Real-World Evidence Partnership

Longitudinal data from commercial anti-amyloid delivery

What it captures

Biomarker-to-outcomes longitudinal panels. ARIA incidence stratified by APOE genotype. Adherence and treatment continuity patterns. Infusion reaction profiles. Treatment trajectory data. Registry-aligned outcomes integrated across CMS NCD, AlzNet, and ALZ-910.

How it is typically structured

Arms-length data agreements, independently fair-market-value documented. Patient consent at intake. HIPAA de-identification protocols throughout. Manufacturer compliance posture and reference templates determine the specific contracting form.

Why ClarityAccessHub

An operating counterparty, not another advisor.

Manufacturers have no shortage of consultants explaining the channel problem. ClarityAccessHub operates the solution — sitting between manufacturers and the AD clinical delivery network, converting manufacturer investment into qualified patients, credentialed delivery sites, registry compliance, and real infusion throughput.

What manufacturers get

  • Aggregated infusion participation. National infusion center coverage through a single contracting counterparty. One conversation, one compliance posture, full member network access.
  • Coordination at scale. The Memory Rx Toolkit operationalizes ARIA surveillance, registry submission, and therapy readiness protocols across every member site.
  • Treatment persistence. Infrastructure designed to reduce operational drop-off between diagnosis, infusion initiation, ongoing monitoring, and longitudinal treatment continuation. Better adherence translates directly to patient outcomes and commercial performance.
  • Real-world evidence. Longitudinal, biomarker-anchored data from commercial anti-amyloid use, available through structured data agreements.
  • Patient throughput. The mechanisms that move patients from referral to first infusion in weeks rather than months.
  • Familiar contracting structures. Partnerships work within manufacturer-preferred contracting templates. ClarityAccessHub doesn't invent frameworks; we operate within yours.

How engagement works

Initial scoping conversation. Align on service categories, deliverable scope, and partnership structure preferences.

Proposal and supporting documentation. ClarityAccessHub provides scoping documents and supporting analysis tailored to your contracting templates and compliance review process.

Definitive agreements. Service contracts and data agreements executed under your standard templates, with structural alignment supported by fair market value documentation.

Ongoing partnership management. Performance reviews on a regular cadence. Service delivery transparency. Documentation maintained for audit-ready compliance.

How we're organized. ClarityAccessHub is the manufacturer-facing operating and contracting layer. The Memory Rx Toolkit is the disease-specific implementation. CerebraLinked is the principal technology platform inside the toolkit. Manufacturers contract with ClarityAccessHub; CerebraLinked operationalizes delivery.

Why Now

What the next five years look like — and why the AD infrastructure has to be built first.

Two convergent shifts make this the AD inflection point. Plasma biomarkers have become operationally credible for population-scale AD screening. And the anti-amyloid and anti-tau pipeline behind today's therapies suggests this is the start of a multi-year, multi-product opportunity in AD that the Memory Rx Toolkit is built to serve.

AD Plasma Biomarkers Are Here

p-tau217
The leading plasma marker for amyloid pathology. Increasingly used alongside or in place of CSF and PET in clinical AD workflows.
p-tau181
Established AD plasma marker. Good correlation with CSF and PET. Widely used in research and AD clinical settings.
Aβ42/40 ratio
Earliest plasma signal for AD. Useful for ruling out AD pathology. Lower specificity alone.
GFAP
Astrocyte activation marker. Adds prognostic value in AD plasma combination panels.
NfL
Neurodegeneration marker. Non-specific to AD but useful for monitoring AD progression.
APOE genotype
Risk stratification. Now clinically meaningful with anti-amyloid ARIA risk profile by genotype.

AD Pipeline Outlook 2026–2032

Anti-amyloid prevention
Sponsor pipelines targeting prodromal and preclinical AD continue to advance. Trial and delivery infrastructure for AD prevention populations will be needed.
Anti-tau therapies
Multiple AD sponsors in mid- and late-stage development. Tau pathology screening and longitudinal monitoring infrastructure becomes increasingly relevant.
Combination AD therapies
Anti-amyloid plus anti-tau combination approaches will likely require multi-modal AD delivery infrastructure.
Earlier-stage AD intervention
As the pipeline shifts toward earlier-stage AD intervention, the qualification, biomarker, and ARIA monitoring infrastructure becomes the rate-limiting factor.
Trial infrastructure demand
Industry-sponsored AD trial activity continues to expand. Sites with established AD workflow, biomarker capability, and ARIA infrastructure are operationally scarce.
Post-market commitments
Real-world evidence requirements for AD therapies continue to grow. Registry-aligned data infrastructure becomes increasingly central to label maintenance and expansion.

Talk to ClarityAccessHub.

For manufacturer partnership conversations — Enhanced Service Contract, Data Agreement, or both.

Get in touch