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Clinical Science

How Quelm turns biology into decision support

Six integrated layers are designed to process multi-source biological data into clinical decision support. Every algorithm is built against peer-reviewed science and established clinical guidelines. Validation is ongoing.

6
Processing Domains
26
Algorithms
350+
IP Claims
HIPAA
Compliant from Day 1

Research foundation

Built on established peer-reviewed science and clinical guidelines.

Pharmacogenomics

Clinical Pharmacogenetics Implementation Consortium (CPIC)

Evidence-based guidelines for gene-drug pairs. Peer-reviewed, freely available.

Cardiac Safety

AHA/ACC Guidelines + CredibleMeds QTc Database

QTc prolongation risk classification. Drug-induced arrhythmia prevention protocols.

Metabolic Modeling

ISO 15197 + ADA Standards of Care

Glucose monitoring accuracy standards. Metabolic health assessment frameworks.

Neuroplasticity

BDNF/MMSE Literature + Psychedelic Research Corpus

Neuroplasticity biomarkers. Treatment response prediction models.

System architecture

Multi-source inputs flow through six processing domains into clinical decision support.

QuelmDecision EnginePGxMetabolicCardiacAI CoachTwinPrivacyMulti-Source InputsClinical Decision Support

Pharmacogenomics

BUILT
Input: Saliva/blood genetic panel
Output: Metabolizer phenotype + drug-dose adjustments

Metabolic Intelligence

BUILT
Input: CGM, blood panels, dietary logs
Output: Metabolic stress index, glucose forecast, trend alerts

Cardiac Safety

BUILT
Input: ECG/HRV wearable data, medication list
Output: Cardiac risk score, QTc trend, safety gate status

Behavioral AI Coaching

BUILT
Input: App interactions, questionnaires, voice journals
Output: Behavioral state, readiness score, coaching plan

Digital Twin Simulation

BUILT
Input: All biomarker streams + behavioral state
Output: Modeled treatment response estimates, biological age, risk trajectories

Privacy Architecture

BUILT
Input: All PHI streams
Output: Local-first processing, de-identified aggregate insights

Validation pipeline

Four-stage pathway from algorithmic validation to regulatory approval.

1
Algorithmic Validation
2024-2026

Internal testing against established clinical guidelines (CPIC, AHA/ACC, ISO 15197). Formula verification, edge-case coverage, safety gate testing.

IN PROGRESS
2
Observational Study
2026-2027

IRB-approved observational study with partner clinics. Outcome tracking for PGx dosing accuracy, metabolic predictions, and cardiac safety alerts.

PLANNED
3
Prospective Pilot
2027-2028

Controlled prospective trial. 500+ participants. Primary endpoints: adverse event reduction, treatment adherence, patient-reported outcomes.

PLANNED
4
Regulatory Pathway
2028+

FDA 510(k) for clinical decision support. Clinical evidence package compilation. Post-market surveillance framework.

PLANNED

Safety protocols

Patient safety is architecturally enforced, not bolted on.

Cardiac Pre-Screening Gate

Multi-gate qualification pipeline designed to ensure cardiac safety clearance before treatment. Includes QTc, electrolyte, and CYP2D6 checks.

PGx Drug Interaction Check

Medication protocols are designed to run through pharmacogenomic interaction analysis. CYP enzyme metabolizer status is used to inform safe dosing ranges.

Multi-Gate Qualification

Physiological, psychological, and social readiness assessed independently. All gates are designed to pass before enrollment proceeds.

Federated Privacy

PHI never leaves the device for model training. Differential privacy budgets enforce mathematical guarantees on re-identification risk.

Clinician Override

Every AI recommendation can be overridden by a licensed clinician. The system supports clinical judgment — it does not replace it.

Quelm is a decision support platform. It does not make diagnostic claims. All recommendations are subject to clinician review and patient consent.

Work with us

Three tracks for clinical partners, researchers, and advisors.

Scientific Advisory Board

Shape research direction, validate clinical algorithms, co-author publications.

Clinical Pilot Partner

Integrate Quelm into your practice. Access clinician dashboard and patient monitoring tools.

Research Data Collaboration

Access de-identified federated insights for population health research and clinical trials.