Synthetic Control Arms (SCA) · FDA 2023 DCT Guidance · Pediatric & Rare Disease Placebo Elimination
Synthetic Control Arms.
Eliminating the ethical and logistical burden of placebo.
In severe, pediatric, and refractory diseases, randomizing patients to placebo is ethically fraught, delays recruitment by years, and causes catastrophic patient dropouts. DeepSensi™ licenses regulatory-grade Synthetic Control Arms (SCA) derived from longitudinal patient cohorts, accelerating Phase II/III development while meeting FDA 2023 DCT and RWE evidentiary standards.
Strategic Value for BioPharma
Transforming Trial Economics and Regulatory Certainty
100% Active Treatment Assignment
By replacing parallel placebo arms with verified synthetic control cohorts, every enrolled subject receives active investigational therapy or optimized baseline care. Caregiver willingness to participate surges, collapsing recruitment timelines from years to months.
High-Dimensional Covariate Balance
DeepSensi's multimodal tensors include 75+ metabolomic markers, microbiome metagenomics, marrow kinetics, and real-time TDM. This enables high-dimensional propensity score matching and G-computation, exceeding the statistical rigor of conventional coarse EHR databases.
Audit-Anchored Evidence Ledger
Every synthetic assertion, covariate match, and outcome event is anchored to a tamper-proof SHA-256 / RSA-2048 cryptographic ledger built to meet 21 CFR Part 11, HIPAA Expert Determination, and FDA Real-World Evidence guidance.
Active SCA Programs
Available Synthetic Control Cohorts (N = 10,000 Each)
EPI-RESOLVE™ SCA
Longitudinal natural history cohorts for early-onset genetic epilepsies, Dravet syndrome, Lennox-Gastaut, and drug-resistant focal epilepsy. Tracks seizure diaries, ASM polypharmacy, and gut-brain metabolic kinetics.
NEURO-RESOLVE™ SCA
Targeted cohorts for regressive autism spectrum disorders, PANDAS/PANS, ME-CFS, and Long COVID neuroinflammation with serial ATEC, Y-BOCS, and kynurenine-pathway biomarker tracking.
IMMUNO-RESOLVE™ SCA
Standard-of-care baseline and biologic-refractory cohorts in Crohn's Disease, Ulcerative Colitis, SLE, and Multiple Sclerosis with serial fecal calprotectin and mucosal cytokine trajectories.
ONCO-SHIELD™ SCA
Chemotherapy marrow toxicity, neutropenia nadir, and relative dose intensity trajectories across multi-drug cytotoxic and checkpoint inhibitor regimens in solid tumors and hematology.
