NSMS National Clinical Trials Center (aTrials™)

Led by Minda Miller, MD

AI-Autonomous Clinical Trials, Drug & Medical Device Studies, Preclinical & Clinical Phases I, II, III

The NSMS National Clinical Trials Center (aTrials™) is a next-generation clinical research execution, therapeutic evaluation, and trial virtualization infrastructure program integrating autonomous protocol operations, medical device verification, digital twins, closed-loop telemetry, real-world data pipelines, and adaptive trial designs to accelerate the translation of biomedical discoveries from preclinical validation through Phase I, II, and III clinical trials and medical device clearance pathways.

Led by Minda Miller, MD, aTrials™ develops the end-to-end operational and computational infrastructure required to transform traditional, fragmented drug development and device testing into intelligent, decentralized, and AI-autonomous clinical trial platforms that maximize patient safety, protocol adherence, and regulatory-grade evidence generation.

aTrials™ Bridges:

  • Autonomous Clinical Trial Operations

  • Investigational Drug & Biologic Development (IND / NDA / BLA)

  • Medical Device & SaMD Clinical Evaluation (IDE / 510(k) / PMA / De Novo)

  • Preclinical-to-Clinical Translational Pipelines

  • Phase I, II, and III Digital & Decentralized Trials

  • AI-Enabled Adaptive & Platform Trial Designs

  • Digital Biomarker & Continuous Device Telemetry Integration

  • Closed-Loop Patient Monitoring & Safety Surveillance

  • In Silico & Digital Twin Control Cohorts

  • Regulatory-Grade Real-World Evidence (RWE)

  • Automated Protocol Adherence & Endpoint Capture

  • Multi-Site Consortium & Ecosystem Orchestration

Mission

To build a trusted national clinical trials infrastructure that executes AI-driven, decentralized, and adaptive clinical studies across preclinical models, medical device evaluations, and multi-phase pharmaceutical trials—accelerating safe, reproducible, and verifiable therapeutic breakthroughs from bench to bedside.

Core Clinical Trials Programs

Drug & Biologic Clinical Development

Comprehensive translational and clinical trial execution across the entire pharmaceutical lifecycle:

  • Preclinical Pharmacology & PK/PD Modeling: Mechanistic drug modeling, bioavailability optimization, and allometric scaling for computational first-in-human (FIH) dose estimation.

  • Phase I Safety & Tolerability: Continuous telemetry integration for rapid dose-limiting toxicity (DLT) detection, adaptive Bayesian dose-escalation (CRM/BOIN), and real-time pharmacodynamic response monitoring.

  • Phase II Proof-of-Concept & Dose Ranging: Biomarker-driven responder enrichment, multi-arm multi-stage (MAMS) adaptive designs, and interim efficacy signal detection.

  • Phase III Pivotal Registrational Trials: Decentralized multi-site trial networks, double-blind algorithmic randomization, automated endpoint adjudication, and regulatory-grade electronic Common Technical Document (eCTD) data formatting.

  • Phase IV & Post-Market Evidence: Continuous safety surveillance, registry-based pragmatic clinical trials, and real-world comparative effectiveness research.

Medical Device & Digital Health Clinical Evaluation

Specialized clinical validation pathways for physical devices, diagnostic systems, wearable telemetry, and Software as a Medical Device (SaMD):

  • Investigational Device Exemption (IDE) Execution: Protocol design, safety monitoring, and clinical evidence gathering for significant risk (SR) and non-significant risk (NSR) devices.

  • Human Factors & Usability Studies: Real-world clinical validation testing under simulated and live patient environments to satisfy FDA/IEC 62366 standards.

  • Diagnostic & Sensor Performance Validation: Multi-site sensitivity, specificity, accuracy, and agreement testing against clinical gold standards.

  • SaMD & AI/ML Algorithm Validation: Rigorous clinical evaluation for Software as a Medical Device, including locked and continuous-learning algorithmic performance, bias mitigation, and clinical decision support (CDS) efficacy.

  • Premarket Pathways & Post-Market Surveillance: Structured trial architectures supporting 510(k) substantial equivalence, De Novo classification, Premarket Approval (PMA), and ongoing Post-Market Clinical Follow-up (PMCF).

AI-Autonomous & Decentralized Clinical Trials

Development of intelligent operational architectures supporting next-generation clinical trial execution:

  • Autonomous subject screening, matching, and electronic consent (eConsent)

  • Continuous at-home and ambulatory physiological telemetry

  • Decentralized trial operations and remote participant engagement

  • Digital protocol execution engines with automated deviation tracking

  • Real-time electronic clinical outcome assessments (eCOA / ePRO)

  • AI-orchestrated clinical supply chain and investigational product management

  • Edge-to-cloud secure trial data synchronization

  • Longitudinal participant monitoring across diverse community settings

These capabilities provide the digital infrastructure connecting trial sponsors, clinical investigators, decentralized trial sites, autonomous robotic platforms, and study participants.

Digital Twin Cohorts & In Silico Controls

aTrials™ pioneers advanced computational modeling to optimize cohort sizing and accelerate study timelines:

  • Generative digital twin synthetic control arms (SCAs)

  • Multi-scale virtual patient cohorts for trial simulation and power modeling

  • Predictive adverse event risk modeling prior to physical dosing or device deployment

  • Rare-disease, pediatric, and specialized cohort augmentation via computational controls

  • Longitudinal trajectory forecasting under varying drug dosing and device settings

These capabilities reduce patient burden, minimize unnecessary placebo exposure, and accelerate regulatory decision-making.

Automated Safety Surveillance & Data Integrity Governance

Rigorous algorithmic frameworks ensuring participant safety and strict regulatory compliance:

  • Continuous algorithmic adverse event (AE) and serious adverse event (SAE) detection

  • Real-time automated safety stopping rule evaluation

  • Source data verification (SDV) automation and electronic data capture (EDC) reconciliation

  • Immutable audit trails and cryptographic data provenance from sensor to regulatory dossier

  • Blinded data safety monitoring board (DSMB) real-time analytics portals

  • Full compliance with GCP/ICH E6(R2)/(R3), 21 CFR Part 11, Part 312 (IND), and Part 812 (IDE) guidelines

Clinical Trial Technology Platforms

  • aTrials™: Autonomous clinical trials, adaptive trial engines, and distributed site infrastructure

  • aDrug™: Pharmaceutical development workflow engine covering preclinical PK/PD through Phase I–IV registrational pipelines

  • aDevice™: Medical device and SaMD clinical trial framework for IDE, 510(k), PMA, and usability validations

  • aPhase™: Phase-specific workflow engines for Phase I safety, Phase II dosing, and Phase III pivotal operations

  • aTwinTrial™: Digital twin synthetic control arms and in silico trial simulation architectures

  • aMonitor™: Real-time continuous participant safety, physiological anomaly detection, and automated DSMB dashboards

  • aProtocol™: Machine-executable trial protocols, automated endpoint capture, and smart eConsent systems

  • aCohort™: AI-driven multi-criteria clinical trial matching, screening, and enrollment optimization

  • Regulatory-Ready Evidence Infrastructure: Audit-trailed, 21 CFR Part 11–compliant data architectures supporting FDA, EMA, and international regulatory filings

R&D / Clinical Trial Domains

  • Autonomous Clinical Trials

  • Investigational Drug Development (Small Molecules & Biologics)

  • Medical Device Clinical Trials (IDE / 510(k) / PMA / De Novo)

  • Software as a Medical Device (SaMD) Validation

  • Phase I First-in-Human Protocols

  • Phase II/III Registrational Trials

  • Adaptive & Master Protocol Trial Designs

  • Decentralized Clinical Trials (DCT)

  • Digital Twins in Clinical Research

  • Synthetic Control Arms (SCA)

  • Continuous Patient Telemetry & Wearable Sensors

  • Biomarker-Driven Enrichment Strategies

  • Clinical Pharmacology & PK/PD Modeling

  • Real-World Evidence (RWE) in Regulatory Science

  • Good Clinical Practice (GCP) & 21 CFR Part 11 Compliance

  • Autonomous Safety Monitoring & Pharmacovigilance

Integrated NSMS Digital Ecosystem

aTrials™ serves as the clinical investigation and operational trial backbone connecting NSMS technologies, preclinical discoveries, and translational platforms:

Together, these platforms establish a closed-loop translational research cycle:

Discover → Formulate Protocol → Virtualize / Simulate → Enroll → Administer / Deploy Device → Monitor & Telemetry → Adapt → Adjudicate Endpoints → Regulatory Dossier

Leadership

Minda Miller, MD

Director, NSMS National Clinical Trials Center (aTrials™)

Lead, AI-Autonomous Clinical Trials, Drug Development & Medical Device Programs

Minda Miller, MD, leads NSMS clinical trial innovations, drug development programs, medical device validation pathways, and digital trial virtualization platforms. Her work focuses on deploying autonomous technologies, adaptive statistical designs, digital twin control models, and decentralized trial infrastructures to transform how therapeutics and medical devices are evaluated, monitored, and delivered to patients.

Under her leadership, aTrials™ establishes the operational and computational trial execution foundation connecting laboratory discoveries, investigational therapeutics, medical device engineering, clinical informatics, and regulatory agencies within a rigorous, patient-centered, and evidence-driven ecosystem.