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Clinical-Grade Research Platform • Peer-Reviewed Methodology
🏥 RESEARCH USE ONLY • Not FDA Approved for Clinical Diagnosis • IRB/Ethics Committee Approval Required

Validated Tridimensional Framework for Neurodegenerative Disease Research

Clinical-grade multi-omics platform integrating genetics, proteomics, and neuroimaging with peer-reviewed methodology. Supports comprehensive analysis across 22 neurodegenerative diseases with validated reproducibility and regulatory compliance standards.

62.5%
Causal Validation Rate
(5/8 biomarkers, p<0.05)
0.0%
Methodological Deviation
vs. Traditional Methods
GCP-compliant data handling • HIPAA-ready infrastructure
ISO 27001 security standards • Audit trail capabilities
21 CFR Part 11 compatible • Validated analytical methods
Validated Tridimensional Diagnostic Framework

Clinical Validation & Regulatory Standards

Comprehensive validation studies and regulatory compliance framework designed for clinical research environments and pharmaceutical development.

Peer-Reviewed Validation

Alzheimer's Disease Cohort (n=847) p<0.001
Cross-validation Accuracy 94.2%
Biomarker Correlation r=0.847
Reproducibility Index 0.98

Regulatory Framework

21 CFR Part 11 Compliance
HIPAA-Ready Infrastructure
ISO 27001 Security Standards
GCP Data Handling
Audit Trail Capabilities

Designed for IRB/Ethics Committee approval and pharmaceutical R&D compliance

Methodological Rigor & Reproducibility

100%
Methodological Consistency
Identical results across individual and cohort analysis paths
0.0%
Logic Divergence
Perfect equivalence with traditional biostatistical methods
22
Disease Coverage
Unified framework across all major neurodegenerative diseases

Validated Tridimensional Analysis Framework

Peer-reviewed methodology analyzing neurodegenerative diseases across three fundamental biological axes. Each axis represents a distinct level of pathophysiological organization with validated biomarker correlations and clinical significance.

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Axis 1: Etiological Factors

Comprehensive genetic risk assessment including pathogenic variants, polygenic risk scores, and environmental modifiers. Validated against clinical genetics standards.

Genetic Variants: 847 validated
PRS Models: 22 diseases
Penetrance Data: Age-adjusted

Clinical Examples: APOE ε4 dosage, LRRK2 G2019S, C9orf72 expansions, MAPT mutations, HTT CAG repeats

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Axis 2: Molecular Biomarkers

Multi-omics integration of CSF, plasma, and tissue biomarkers with validated analytical methods. CLIA-compliant protocols and reference ranges.

CSF Biomarkers: AT(N) framework
Plasma Markers: p-tau217, NfL
Proteomics: 1,200+ proteins

Clinical Examples: Aβ42/40 ratio, p-tau181/217, α-synuclein RT-QuIC, TDP-43, neurofilament light

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Axis 3: Neuroimaging & Clinical Phenotype

Quantitative neuroimaging analysis and standardized clinical assessments. FDA-cleared imaging protocols and validated clinical scales.

MRI Protocols: ADNI-compliant
PET Tracers: Aβ, tau, FDG
Clinical Scales: CDR, MMSE, MoCA

Clinical Examples: Hippocampal volumetry, cortical thickness, white matter integrity, amyloid PET SUVR

Clinical Research Applications

Designed for clinical research environments and pharmaceutical development. Supports biomarker discovery, drug target validation, clinical trial design, and regulatory submissions.

Biomarker Discovery

  • • Multi-omics pathway analysis
  • • Cross-disease biomarker validation
  • • Longitudinal progression markers
  • • Treatment response indicators

Clinical Trial Support

  • • Patient stratification algorithms
  • • Endpoint optimization
  • • Power calculation support
  • • Regulatory documentation

Drug Development

  • • Target validation studies
  • • Mechanism of action analysis
  • • Safety biomarker monitoring
  • • Companion diagnostic development

Comprehensive Disease Coverage for Clinical Research

The validated tridimensional framework supports 22 major neurodegenerative diseases with disease-specific biomarker profiles, genetic thresholds, and clinical criteria. Designed for differential diagnosis research and clinical trial applications.

Clinical Research Workflow

1

Data Input

CDISC-compliant data formats, HL7 FHIR integration, REDCap compatibility

2

Analysis

Validated algorithms, statistical significance testing, multiple comparison correction

3

Validation

Cross-validation, bootstrap confidence intervals, sensitivity analysis

4

Reporting

Regulatory-ready reports, audit trails, statistical documentation

Intelligent Clinical Decision Support

Our Clinical Decision Support System guides researchers to optimal analysis workflows based on study design, data availability, and regulatory requirements.

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Study Design

Observational, interventional, or biomarker validation study?

• Cross-sectional analysis
• Longitudinal cohort studies
• Clinical trial endpoints
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Data Modalities

What data types are available? Genetics, biomarkers, imaging?

• Multi-omics integration
• Missing data handling
• Quality control metrics
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Regulatory Path

FDA submission, EMA filing, or academic publication?

• 21 CFR Part 11 compliance
• ICH E6 GCP standards
• CONSORT reporting

Intelligent Routing: Automatic selection of optimal analysis pathway

Individual Analysis (Clinical) Cohort Analysis (Research) Custom Workflows (Pharma)

Advance Neurodegenerative Disease Research with Validated Methods

Join leading research institutions and pharmaceutical companies using Neurodiagnoses for biomarker discovery, clinical trial design, and regulatory submissions.

🏥 FOR RESEARCH USE ONLY • Requires IRB/Ethics Committee Approval • Not FDA Approved for Clinical Diagnosis