Turning Digital Evidence into Regulatory-Trusted Data

Our Human Digital Twin AI platform transforms simulation into FDA-accepted clinical evidence—de-risking trials and accelerating approval with credible, model-based data.

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Clinical Trials-as-an Agentic Service

Nexus Healthcare is redefining the $85 billion clinical-trials industry through a pioneering Human Digital Twin AI platform that powers in-silico clinical trials.

Through FDA-aligned initiatives and international regulatory collaboration, Nexus delivers regulatory-grade evidence up to 50 percent faster and at lower cost than traditional trials — helping bring safe, effective therapies to patients sooner.

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Our Clinical Trials-as-an-Agentic Service integrates advanced computational modeling, FDA-referenced credibility frameworks (ASME V&V 40), and AI-generated virtual patient cohorts to supplement, reduce or replace costly animal and human testing.

This approach supports the FDA’s ongoing Digital Health and In Silico initiatives as a modern pathway for model-informed evidence generation.

For medical-device and biotech innovators, Nexus Healthcare provides a clear path from concept to approval — combining Human Digital Twin simulation, regulatory strategy, and clinical integration across the Total Product Life Cycle. Sponsors can validate designs earlier, reduce clinical and regulatory risk through predictive modeling, explore biomarker and endpoint feasibility, and achieve regulatory acceptance for in-silico evidence within Q-Sub, IDE, and label-expansion submissions. 

Nexus Healthcare turns simulation into regulatory-trusted evidence — bridging the gap between AI platforms and clinical reality.

  • Regulatory-Ready

    Built on ASME V&V 40 and FDA guidance to deliver audit-ready, submission-grade evidence.

  • Virtual Patient Libraries

    Scalable, validated model libraries spanning multiple indications and device types.

  • Full Lifecycle Support

    From design to post-market monitoring — not just one trial phase.

  • Hybrid SaaS + Service

    Combines agentic AI software, modeling IP, and expert regulatory delivery.

  • Cross-Therapeutic Reach

    Applied across cardiovascular, orthopedic, neuro, metabolic, and rare-disease domains.

Nexus Healthcare transforms simulation into submission-ready science — redefining how digital evidence drives faster, safer approvals.

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Regulatory Confidence

Nexus Healthcare supports sponsors in conducting FDA-aligned In-Silico Clinical Trials (ISCTs) by integrating computational modeling and simulation (CM&S) directly into regulatory workflows. Our Quality Management System includes a credibility framework which is built on the ASME V&V 40 standard and FDA’s 2023 guidance paper. 

Each ISCT project includes a structured Credibility Assessment Plan and Credibility Assessment Report consistent with FDA’s expectations for Q-Submission (Pre-Sub) review. Using the FDA format, we ensure modeling evidence, verification, validation, and uncertainty quantification are documented in an audit-ready, machine-readable submission package suitable for Q-Subs, IDEs, and label expansions.

Our platform accelerates review by providing transparent traceability between virtual patient data, simulation results, and clinical endpoints—helping sponsors meet FDA’s goal of advancing credible, model-informed development across the Total Product Life Cycle.

Ready to Redefine Your Next Clinical Trial?

Connect with our team to explore how Human Digital Twin–based evidence can reduce human cohort size, shorten timelines, and strengthen regulatory confidence.