arXiv Computer Vision By Gabriele Campanella, Matthew Croken, Olga Lukatskaya, Jane Houldsworth, Ricky Kwan, Peter Sch\"uffler, Chad Vanderbilt

STEP: A Modular Silent Trial Engine for Operational Evaluation of Digital Pathology AI in Routine Workflow

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FMRP-LEAN: A HIPAA-Compliant AI-Augmented LIMS Architecture for End-to-End Clinical Assay Workflow Optimization

Clinical biomarker workflows in translational research settings often rely on spreadsheet-driven tracking, manual quality control (QC) reconciliation, and loosely integrated systems, resulting in limited state visibility, delayed reporting, and increased operational risk. These challenges are particularly pronounced in multi-day assays such as Luminex-based quantification of Fragile X Messenger Ribonucleoprotein (FMRP), where HIPAA-compliant data governance, deterministic workflow progression, and coordinated communication across laboratory and clinical teams are required.