STARDEEP™ · EVIDENCE-GROUNDED AGENTIC AI FOR DCTS

Agentic AI for clinical trial.
Grounded in evidence and governed for every decision.

StarDeep transforms NeuTigers' real-world clinical-trial experience, multimodal longitudinal data and operational know-how into specialized AI-agent workflows for decentralized clinical trials.

Outputs are grounded in defined source evidence, checked against protocol and operational rules, independently cross-verified, and escalated for human review when needed.

GROUNDReal-world evidence Multimodal · longitudinal · governed
ORCHESTRATESpecialized agent swarms Decompose · route · execute
VERIFYControlled decisions Rules · cross-checks · human review
Five years of controlled trial executionParticipant-level multimodal evidenceIndependent model cross-checkingHuman-accountable escalation

THE INDUSTRY GAP

Agentic AI is easy to demonstrate. Clinical-trial reliability must be proven.

StarDeep is designed around a stricter premise: each operational agent should be evaluated for a defined context of use, against an established reference standard, before it is trusted in a trial workflow.

EXPERIENCE CONVERTED INTO INTELLIGENCE

Controlled trial execution became a machine-verifiable operating framework.

NeuTigers codifies approved inputs, expected outputs, validation rules and human decision points across the trial pipeline—turning operational know-how into reusable controls for specialized agents.

01

Protocol design

Study intent, endpoints and operating rules

Input → rule → output → review
02

Regulatory preparation

Required evidence, documents and approvals

Input → rule → output → review
03

Study execution

Participants, sites, devices and exceptions

Input → rule → output → review
04

Data operations

Quality checks, reconciliation and monitoring

Input → rule → output → review
05

Algorithms + apps

Validated features, models and interfaces

Input → rule → output → review
06

Reporting + audit

Traceable decisions and study outputs

Input → rule → output → review
STARDEEP™ EVIDENCE FOUNDATIONParticipant-level linkage Structured for grounding, benchmarking and exception detection
MODALITIES Wearable physiology CGM dynamics Biomarkers Clinical measures
POPULATIONS Risk states Disease phenotypes Demographic diversity Longitudinal outcomes
SETTINGS United States Europe MENA Multiple devices

GOVERNED ARCHITECTURE

Knowledge grounding and verification surround every agent workflow.

StarDeep does not rely on one general-purpose model to manage an entire trial. An accountable supervisor coordinates fit-for-purpose agents and routes material exceptions to human experts.

VERIFICATION GATEWAY

No single model is the final authority.

Source-evidence attribution Deterministic rule checks Data completeness checks Independent model cross-checking Disagreement thresholds Human review + escalation

STARDEEP TRIAL OPERATIONS BENCHMARK

Measured against real trial tasks—not generic AI benchmarks.

Performance is evaluated task by task, for a defined context of use, using historical cases, expert-approved references and agreed acceptance thresholds.

Dimension What is measured Reference
Task accuracy Agreement with expert-approved reference outputs Expert baseline
Evidence fidelity Material statements supported by authorized sources Source attribution
Protocol adherence Correct application of study rules and deviation logic Protocol test set
Safety sensitivity Detection of predefined safety-critical conditions Safety cases
Escalation quality Appropriate escalation with controlled false-alert burden Human adjudication
Operational efficiency Cycle time, correction burden and cost per completed task Current workflow

Proof status: Site claims should move from pilot objective to demonstrated outcome only after results are measured, reviewed and documented for the specified context of use.

OPERATIONAL VALUE

From manual coordination to continuously governed trial operations.

StarDeep pilots are designed to quantify improvements without transferring accountability away from sponsors, investigators or clinical experts.

FASTER

Shorter review cycles

Measure time from incoming trial data to a validated operational output.

HIGHER QUALITY

Earlier exceptions

Measure detection of missing, inconsistent or anomalous information.

MORE SCALABLE

Parallel execution

Coordinate specialized tasks while maintaining dependencies and oversight.

MORE INSPECTABLE

Decision provenance

Reconstruct the evidence, rule, model, reviewer and action behind each output.

VALIDATE BEFORE YOU SCALE

Design a StarDeep™ validation pilot.

Establish the human baseline, replay historical cases, operate in shadow mode and compare quality, safety, time and cost before broader deployment.

01

Define

Select the workflow, context of use and acceptance thresholds.

02

Baseline

Measure current human performance, effort and cycle time.

03

Replay

Test historical cases withheld from the active agent workflow.

04

Shadow

Run alongside the live process with no autonomous authority.

05

Decide

Compare quality, safety, time and cost before scale-up.

StarDeep™ is an investigational operational platform. Capabilities, validation requirements and human oversight should be defined for each intended context of use. References to regulatory frameworks do not constitute certification or regulatory authorization.