Decentralized Registries.
Breakthrough Discovery at Scale.
Legacy clinical research traps patients in geographical barriers, multi-year recruitment delays, and single-organ specialty silos. DeepSensi DCT™ unites our Consilium AI Diagnostic Engine with home-based multi-omic biomarker telemetry, turning intractable chronic disease cohorts into active discovery networks that study the paths to lasting clinical remission.
SYSTEMS BIOLOGY // THE CLINICAL COURT OF LAST RESORT
Difficult Cases, Cross-Domain Systems Biology & The "Inter-Specialty White Space"
Medicine is Departmentalized. Human Biology is Not.
Every major chronic disease that becomes "medically intractable" lives at the intersection of organ systems that no single specialist manages. When an epilepsy patient fails three anti-seizure medications, neurology stops looking; yet the true driver is frequently clostridial gut neurotoxins (HPHPA, 4-cresol) blocking dopamine beta-hydroxylase. When an endometriosis patient suffers for 8 years, gynecology excises lesions while ignoring systemic peritoneal cytokine cascades and estrobolome dysbiosis. DeepSensi was engineered specifically to master this Inter-Specialty White Space, synthesizing multimodal biomarker tensors across its deterministic cognitive architecture to turn medical dead-ends into testable root-cause hypotheses.
PRE-ENROLLMENT OPEN IN MOST COUNTRIES // ENROLLMENT OPENS COUNTRY BY COUNTRY · UNITED STATES FIRST
Pre-Enroll in the RESOLVE™ Registries
Pre-enrollment is an expression of interest: your email, your country and the registry you choose, nothing more. It has its own page.
RESOLVE in the United States: in preparation (IRB submission in preparation, the first country to open).
DEEPSENSI // COUNTRY BY COUNTRY
Where RESOLVE opens, country by country
RESOLVE™ pre-enrollment is open in most countries. Enrollment opens in stages, the United States first, each under independent ethics (IRB) review; countries follow in order of demand.
| Country or region | RESOLVE registry |
|---|---|
| USUnited States | In preparationIRB submission in preparation, the first country to open |
| CACanada | Next |
| AUAustralia | Next |
| +European Economic Area | Not yet open |
| +United Kingdom, Switzerland, mainland China, Thailand, Türkiye | Not available |
| +Every other country | Pre-enrollment opencountries open in order of demand |
CLINICAL TRIAL ARCHITECTURE // DECENTRALIZED DCT VS CONVENTIONAL CRO
Decentralized DCT vs. Traditional Institutional CRO Trials
Eliminating site-based delays, recruitment bottlenecks, and ethical placebo dilemmas while preserving the sanctity and legal autonomy of the patient-physician relationship.
| Dimension | Traditional Institutional CRO Trials | DeepSensi™ Decentralized Clinical Trials (DCT) |
|---|---|---|
| Operational Reach & Speed | Months of site initiation before the first participant is seen; most of the effort goes into sites, monitoring visits and travel rather than into patients. | Global Longitudinal Reach. Continuous multi-omic telemetry and algorithmic bounding uniting distributed cohorts into rapid therapeutic discoveries. |
| Geographic Access & Equity | Confined to major university hospitals. 80% of trials in complex and rare disease fail to recruit on schedule due to patient travel burden. | 100% home & local participation. Routine telemetry and the participant's own local laboratories; countries open in stages as each one's requirements are met. |
| Physician Autonomy | Displaces the family physician or managing neurologist in favor of an unfamiliar tertiary clinical trial investigator. | Managing physician retains 100% clinical control. Doctor co-signs and authorizes all interventions via the secure Clinician Workbench. |
| Control Cohorts & Ethics | Ethically fraught 1:1 placebo randomization in progressive pediatric or severe autoimmune disease; catastrophic dropout rates. | Zero-placebo synthetic control arms. Regulatory-grade Synthetic Control Arms (SCA) matched via longitudinal digital twins. |
| Data Latency & Density | Sporadic 3-to-6-month hospital visits; manual paper/EDC case report forms subject to human transcription errors and long recall bias. | Continuous multimodal Real-World Evidence (RWE). Serial OAT, metagenomic, and pharmacokinetic tensors updated in near-real-time. |
PARTICIPATION ARCHITECTURE // FREE · VOLUNTARY · WITHDRAW AT ANY TIME
How the RESOLVE Registry Operates
Under the Belmont Report and the Common Rule (45 CFR § 46), consent to research must be voluntary and free of undue influence, so participation in RESOLVE never requires payment. Here is how DeepSensi achieves 100% regulatory purity and zero bioethical coercion.
Study Participation is Exactly $0.00
Joining any of the 9 RESOLVE observational cohorts will carry zero study entry fees. There are no site fees, no monitoring charges, and no data submission tariffs. Participation is voluntary and begins only with an electronic Informed Consent Form (e-ICF) approved by an independent Institutional Review Board (IRB).
Who Can Take Part
Who can take part is set out only in the study’s public registration and in the study information approved by the ethics committee. Taking part never depends on buying anything.
Complete Withdrawal Autonomy
A participant may withdraw from the RESOLVE clinical research registry at any second with a single toggle in their account settings without canceling, restricting, or degrading their independent commercial Precision Suite software access. This strict decoupling completely eliminates financial coercion under 45 CFR § 46.
ACUTE INPATIENT COMPANION PROTOCOL // PROTOCOL DS-CLIN-2026-SILENT-DS
SILENT-DS™: Inpatient Diagnostic Accuracy Investigation
While the 9 RESOLVE™ registries track longitudinal outpatient chronic disease remission, SILENT-DS™ validates the Cognitive Engine across 10,000 acute hospital internal medicine admissions in observer-blinded silent mode. Operating with zero EHR clicks, zero alert fatigue, and zero bedside malpractice liability.
- Zero Care Interruption & Zero Bedside Malpractice
- Operating in observer-blinded silent mode across routine hospital EHR data feeds. Zero clinician clicks, zero alert fatigue, and zero bedside malpractice liability. Diagnostic concordance is evaluated strictly post-discharge under independent expert adjudication.
- Edge Gateway & Coded Clinical Data
- Plug-and-play DeepSensi Edge Gateway handles on-premise identifier removal within the hospital data center. Only Coded Clinical Data transmits via mTLS 1.3 to the DeepSensi Supercluster for passive inference—identifiable patient data never leaves your perimeter.
9-PILLAR CLINICAL REGISTRY PORTFOLIO // DUAL-REGISTERED: OSF (DOI: 10.17605/OSF.IO/VPS9D) · CLINICALTRIALS.GOV PRS IN PROGRESS · PORTFOLIO DS-CLIN-2026
The 9 RESOLVE™ Clinical Registry Pillars
Select a specialized medical domain below to inspect primary scientific endpoints, eligibility criteria, and clinical trial architecture. Target cohort: N = 90,000 subjects (10,000 per pillar). Study participation is 100% free ($0.00).
EPI-RESOLVE™
Studying drug-resistant epilepsy, Lennox-Gastaut, Dravet, and SUDEP risk.
NEURO-RESOLVE™
Autism Spectrum Disorder with immune endophenotype, PANDAS/PANS, ME/CFS, and Neuro Long COVID.
IMMUNO-RESOLVE™
Biologic-refractory Crohn's, Ulcerative Colitis, Systemic Lupus (SLE), and Relapsing-Remitting MS.
CARDIO-RESOLVE™
Microvascular angina (INOCA), HFpEF, postural orthostatic tachycardia (POTS), and resistant hypertension.
METABO-RESOLVE™
Mitochondrial cytopathies, organic acidemias (MMA/PA), FAOD, MASH/MASLD, and labile glycemic instability.
RARE-RESOLVE™
Undiagnosed multi-system pediatric syndromes, ultra-rare Mendelian inborn errors, and N-of-1 molecular phenotyping.
ONCO-SHIELD™
Bone marrow nadir protection, pharmacogenomic de-compounding, and maintaining chemo Relative Dose Intensity (RDI ≥ 85%).
ENDO-RESOLVE™
Deep infiltrating endometriosis, adenomyosis, refractory PCOS, and chronic pelvic neuro-inflammation.
MIND-RESOLVE™
Treatment-Resistant Depression (TRD), neuroinflammatory bipolar depression, and gut-brain metabolic axis breakdown.
BIOMARKER TELEMETRY // PATIENT PRECISION TENSOR T_PATIENT
The Patient Precision Tensor: T_patient
Synthesizing multi-omic and telemetric layers across 60+ biological knowledge bases into an auditable clinical decision dossier.
Urine Organic Acids (OAT)
Quantification of 75+ microbial, mitochondrial, neurotransmitter, and nutritional metabolites. Captures anaerobic gut overgrowth (Clostridia), Krebs cycle stalls, and oxidative phosphorylation uncoupling.
Stool Microbiome Sequencing
Deep metagenomic profiling of intestinal microbial ecology, mucosal barrier integrity, short-chain fatty acid synthesis, and systemic endotoxin translocation vectors.
Marrow & Therapeutic Drug Monitoring
Serial peripheral blood smears, ferritin, liver/renal clearance, and real-time pharmacokinetic monitoring of polypharmacy compound interactions to prevent compound toxicity.
Clinician Co-Signature Portal
DeepSensi synthesizes multi-layer tensors into a deterministic Evidence Dossier anchored in DSS-001. The treating physician retains 100% legal, diagnostic, and prescribing autonomy.
REGULATORY PRECEDENT // DECENTRALIZED PROTOCOL GOVERNANCE & IRB OVERSIGHT
Bioethical, Legal & Regulatory Architecture
How DeepSensi DCT operates with 100% regulatory purity across the Belmont Report and the Common Rule (45 CFR § 46).
Belmont Report & 45 CFR § 46 Alignment
Research ethics require that consent is never bought or pressured, and review boards look closely at any cost placed on participants. In DeepSensi DCT, participation in every RESOLVE registry is exactly $0.00 (100% free).
Dual-Consent Architecture
DeepSensi maintains strict separation of commercial software EULA and research electronic Informed Consent (e-ICF). Zero Coercive Coupling: A patient may withdraw from the clinical research registry at any moment with a single click without terminating, restricting, or degrading their software subscription. This completely eliminates financial coercion under 45 CFR § 46.
REGULATORY STATUS // FDA PRE-SUBMISSION (Q-SUB) & CDS
Clinical Decision Support & FDA Pre-Submission
FDA Pre-Submission (Q-Sub) submitted July 31, 2026. (FDA docket Q262487.)
Precision Suite is clinical decision support software for licensed physicians. We believe it meets the non-device criteria of section 520(o)(1)(E) of the FD&C Act. FDA has not reviewed or confirmed this. It has not been cleared, approved, or otherwise authorized by FDA, and it makes no diagnostic accuracy claims. Regulatory status: deepsensi.com/regulatory
CLINICAL PRE-SCREENING // ACCELERATED ONBOARDING TELEMETRY
Data Prerequisites: Prepare Your Lab Biomarkers for the Precision Suite
DeepSensi is an advanced computational intelligence system, not a generic symptom checker. To achieve deterministic precision upon Suite activation, have objective metabolic and metagenomic results ready for physician review. They are inputs to the commercial software, ordered by you and your own physician at a laboratory of your choice; pre-enrollment itself requires no test.
Urine Organic Acids Test (OAT)
Quantifies 75+ microbial metabolites, clostridial neurotoxins (HPHPA, 4-cresol), Krebs cycle stalls, and neurotransmitter breakdown. Order through your own physician at any accredited laboratory of your choice. DeepSensi names the type of test, never a laboratory, and receives nothing from any of them.
Comprehensive Stool Microbiome
High-depth sequencing of gut microbial ecology, opportunistic pathogens, short-chain fatty acid production, and mucosal barrier integrity markers (fecal secretory IgA, calprotectin, zonulin).
Comprehensive Metabolic & CBC Panel
Standard fasting blood chemistry: complete blood count (CBC with differential), comprehensive metabolic panel (CMP), hs-CRP, fasting insulin, ferritin, and organ clearance indices (eGFR, ALT/AST).
Local Diagnostic Autonomy: Patients maintain direct relationships with their local physicians and diagnostic labs. All laboratory files must be provided in original PDF format for client-side identifier removal and local cryptographic signing.
Solutions
Further functions
- Laboratory panels included with the program: organic acids, stool microbiome, metabolic and CBC panelsNot available in your region yet