Nxtcure Labs

Agents do the routine work of feasibility.

Nxtcure Labs is changing the future of medicine through running clinical trials end to end. People make the calls. Galen is our full-stack AI-driven CRO: thirteen purpose-built agents run a study end to end in lifecycle order, and every action with clinical, safety, regulatory or financial consequence stops in one review queue until a qualified human approves it.

  • Thirteen agents, in the order a trial unfolds
  • One human review queue. There is no second path.
  • Plain-language reasoning on every action
Book a demo

Designed to the FDA and EMA January 2026 guiding principles for AI in drug development

Orchestrate · CTX-NSCLC-301

Phase 3 · 450 subjects · 15 sites

Running

  1. Feasibility

    Done

    Enrollment burden scored; 15 sites ranked

  2. Site activation

    Done

    Contract aging 41 d against the 77 d benchmark

  3. Monitoring

    Review

    Site 12 KRI 0.74 · on-site visit proposed for review

  4. Safety

    Review

    Serious AE, grade 3 · to safety physician, critical

  5. Biostatistics

    Running

    Disposition and AE tables, awaiting validation gate

13 agents2 awaiting human review · 0 silent failures

Backed by Y Combinator

Y Combinator

Founded at Harvard and MIT

Harvard UniversityMIT

Nxtcure Labs partners

National Cancer InstituteAnthropicOpenAINVIDIA Inception ProgramNational Cancer InstituteAnthropicOpenAINVIDIA Inception Program
The human checkpoint

Reviewed by Board of Oncologists

Nxtcure Labs provides a certified board of oncologists. Every automated action with clinical, safety, regulatory or financial consequence stops in one shared review queue until a qualified human approves or rejects it. Software does the paperwork; qualified people make the medical, safety and regulatory calls.

  • Serious adverse events are never closed by software
  • Causality is never decided by software
  • Patient contact is never autonomous, and matched candidates are never auto-enrolled
  • A card is decided exactly once, with who and when on record
See the queue on a live study

Review queue · STS-201

Phase II soft-tissue sarcoma · everything judgment-bearing exits here

4 open

Serious adverse event

critical

Grade 3 febrile neutropenia · anthracycline arm, cycle 2 · hospitalised · causality for a safety physician

Waiting on: Safety physicianRejectApprove

Cardiac safety threshold

high

LVEF fell 12 points from baseline on echo · cumulative anthracycline dose review before cycle 5

Waiting on: Medical monitorRejectApprove

Central pathology disagreement

high

Site called leiomyosarcoma; central read undifferentiated pleomorphic sarcoma · eligibility confirm

Waiting on: Principal investigatorRejectApprove

Protocol draft v0.3

medium

Phase II soft-tissue sarcoma · RECIST 1.1 imaging every 6 weeks · amendment risk 0.28

Waiting on: Regulatory leadRejectApprove

Decided exactly once: if someone else already decided, the second reviewer sees who, and when, instead of a button.

The agent pipeline

Thirteen agents, in the order a trial unfolds

One request sends thirteen specialists through the study in lifecycle order: feasibility, protocol, activation, recruitment, monitoring, data, safety, retention, termination watch, supply, biostatistics, medical writing, TMF. Each one does the work, skips it, or raises its hand for a person.

  • Every run records plain-language reasoning, including skips and failures
  • An agent crash becomes a high-risk review task, never a silent failure
  • Re-runs are safe: nothing is duplicated or double-escalated
Walk the pipeline with us

Runs today on CDISC SDTM data: a synthetic Phase 3 NSCLC study (450 subjects, 15 sites, 13 countries, 2,840 adverse events) and CDISCPILOT01 (306 subjects, 17 sites).

Lifecycle order

13 agents · 4 pillars

Study Start-Up & Design

  1. 1Feasibility
  2. 2Protocol
  3. 3Activation

Clinical Operations

  1. 4Recruitment
  2. 5Monitoring
  3. 6Retention
  4. 7Termination watch
  5. 8Supply

Data, Safety & Analytics

  1. 9Data management
  2. 10Safety
  3. 11Biostatistics

Documentation & Quality

  1. 12Medical writing
  2. 13TMF audit

Every run is recorded: what the agent did, what it skipped and why, in plain language, per study.

Four pillars

One orchestration layer across the whole study

Nxtcure Labs CRO Agent Galen revolutionizes medicine by advancing next generation treatments in oncology through concurrently managed clinical trials.

01

Start-up

Study Start-Up & Design

Protocol drafting with an amendment-risk score against the SPIRIT checklist, feasibility and site ranking, and activation readiness tracked against the 77-day benchmark.

02

Operations

Clinical Operations

Risk-based monitoring with a KRI scorecard per site, drug-supply forecasting with a 15% buffer, dropout prediction and a termination-risk watch.

03

Data & safety

Data, Safety & Analytics

Query generation and auto-resolution on a 14-day SLA, pharmacovigilance triage that always escalates serious events, and TLFs behind a double-programming validation gate.

04

Quality

Documentation & Quality

CSR drafting with mandatory sign-off, a self-auditing Trial Master File, PubMed evidence links for every review, and print-ready PDFs.

Work with GalenOps

Run your next oncology study with agents

Book a demo and we will walk the review queue, the reasoning trail and the agent pipeline on a live synthetic Phase 3 study.

We will send a calendar link, not a newsletter.