26-agent pipeline · Research Use Only · Compliance-ready

Less time on reports. More time on scientific decisions.

With 26 specialized AI agents, AiLabrix accelerates the path from clinical dataset to review-ready report, automating analysis, validation and documentation.

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CLIA-ready ISO 15189-aligned GxP-aligned · Audit trail
26 agents orchestrated 5 languages (IT · EN · ES · DE · FR) ELISA · qPCR · Flow · NGS · Chem · Metabolomics · Hema 100% append-only audit trail
Features

Everything you need to close a reproducible analysis.

From CSV upload to signed report: every step is tracked, verifiable, and designed for teams that need evidence defensible in audit.

Intelligent upload + LIMS sidecar

Drag-drop CSV, TSV, Excel. Automatic detection across 12 assay types (PCR, immunoassay, flow cytometry, mass spectrometry, sequencing, imaging, drug screening, microbiology, cell biology, cell viability, clinical chemistry, metabolomics). Optional <filename>.lims.json sidecar as ground-truth input to the arbiter.

CSV / XLSXLIMS sidecar12 assay typesMIQE-ready

HIPAA Safe Harbor PII gate

18-category sanitization (names, addresses, dates, email, SSN, MRN, IP, CF italiano, ...) runs before any LLM touches the data. Two-pass defense: deterministic regex + lookup, then LLM verification on residuals. Audit records column names + categories — never raw values.

HIPAA Safe Harbor18 categories2-passAudit-safe

Guided inference + bootstrap CIs

Parametric vs non-parametric auto-selected from Shapiro-Wilk + Levene. Hedges' g, rank-biserial, epsilon², odds ratio — all with 1000-iter bootstrap-BCa confidence intervals. Benjamini-Hochberg FDR stratified per family (biomarker discovery / confirmatory / demographic / QC).

Shapiro-WilkHedges' gBootstrap-BCaPer-family BH

26 agents + gated AI arbiter

Deterministic LangGraph orchestration with a Fase 3 LLM arbiter for ambiguous assay detection. Fires only when keyword + column-semantic confidence < 70 or disagreement. Anti-bias alphabetical prompt, SHA-256 cache, automatic fallback to keyword top-1 on parse error.

LangGraphAI arbiterAnti-biasSHA-256 cache

R&D-grade figures + signable PDF

Okabe-Ito daltonic-safe palette, Inter Display + JetBrains Mono, 300 dpi PNG, editable SVG (text stays text), vector PDF with TrueType-embedded fonts. Every SVG carries provenance (pipeline version, git SHA, dataset hash, model ID, seed, timestamp) in a structured metadata block.

Okabe-Ito300 dpiSVG + PDFProvenance

Audit + per-call cost tracking

Append-only action log (login, gate, config). Per-LLM-call audit (model, tokens, cost USD, latency, outcome) with 90-day retention and GDPR Right-to-be-Forgotten query by dataset hash. Compliance flags per assay: MIQE (PCR), STARD (immunoassay), CLSI EP28 (clinical chemistry), MINSEQE (sequencing).

MIQE / STARDCLSI EP28GDPR90-day retention

External scientific annotations

Automatic enrichment against HMDB (metabolomics), KEGG + Reactome pathways (hypergeometric), STRING PPI networks, MSigDB hallmark GSEA, LOINC clinical reference ranges. Async via Dramatiq queue with exponential-backoff retry and a 30-day disk cache. Fail-soft: API outages never block the report.

HMDBKEGG + ReactomeSTRING PPIGSEA hallmark

120-dataset gold-set benchmark

Reproducible precision/recall baseline: 60 synthetic datasets (easy / medium / hard variants across 12 assay types, deterministic seeds) + 60 public pointers (GEO, MetaboLights, PRIDE, ImmPort, PhysioNet). Measures top-1 / top-3 accuracy, per-type F1, latency p50/p95/p99, cost USD per call.

120 datasetsPer-type F1p95 latency$/call

EU data sovereignty + multi-provider LLM

Switch the reasoning engine without redeploying: Anthropic Claude, OpenAI GPT, or fully-local Ollama. Set AILABRIX_EU_MODE=1 to disable every cloud LLM and force on-prem inference — zero egress, full GDPR posture. Self-hosted single-tenant or EU-hosted SaaS, your choice.

Anthropic / OpenAI / OllamaEU mode zero-egressGDPR-firstSelf-host or SaaS
Compliance & Validation

Built for the regulatory track, today.

RUO software with a compliance-ready spine: e-signatures, CAPA, vigilance triggers, PMS dashboard, validation harness with hash-stamped evidence ZIP. Not certified — but the artefacts an auditor expects are already there, generated nightly, and traceable to ISO 13485, IEC 62304, ISO 14971, ISO 15189, IVDR and 21 CFR Part 11.

21 CFR Part 11 e-signatures

Every signing event re-authenticates the operator (no session reuse), captures intent + statement, computes a SHA-256 over user_id + artifact + statement + microsecond timestamp, and writes an immutable signatures row plus an audit chain entry. verify_signature_chain() walks the whole table for forensic integrity checks.

§11.10(e)§11.200(a)(1)Append-onlyHash-chained

CAPA workflow with state machine

open → investigating → action → verifying → closed. Closure REQUIRES a signed approval (uses the e-sig module). Per-CAPA: root cause, action plan with owners + due dates, effectiveness check, signed closure with chain-of-custody to the source incident.

State-machineSigned closureAction itemsEffectiveness check

Vigilance triggers + auto-CAPA

6 event types (job_failure, detection_drift, qa_gate_blocked, clinical_flag, user_complaint, audit_chain_break). 4 trigger rules: R1 critical severity, R2 clinical impact, R3 repeat-rate (≥3 events on same playbook in 14d), R4 audit chain break. MDR/IVDR-style summary export ready for vigilance reporting.

6 event types4 trigger rulesMDR / IVDR exportAuto-CAPA

Post-Market Surveillance dashboard

10+ KPIs roll up nightly: jobs/month per phase, failure rate, CAPA throughput + median time-to-close, open vigilance events, signature throughput, audit chain integrity score. CSV export for export to GRC tools. Monthly PMS PDF auto-rendered on the 1st of each month with provenance footer.

10+ KPIsDaily snapshotMonthly PDFCSV export

Library-backed math + reproducibility hash

Welch's t via scipy.stats, BH FDR via statsmodels, Kaplan-Meier + log-rank via lifelines, PERMANOVA via scikit-bio. Every run captures library versions + computes SHA-256(versions, prompt_hash, seed) — identical inputs guarantee bit-for-bit identical numerical output. 30 golden agreement tests pin 1e-9 tolerance vs reference impls.

scipystatsmodelslifelinesscikit-bio30 golden cases

Validation suite + nightly CI + evidence ZIP

21 validation protocols across 17 healthcare R&D phases run nightly on GitHub Actions, with drift detection (new_failures / new_passes / still_failing) and Slack alerts on regression. One-click build_evidence_package.py emits a hash-stamped ZIP with SDLC, RMF, VVR, traceability matrix mapping every protocol to its ISO/IEC clause, 90 days of run records, audit chain snapshot, and library provenance — ready for hand-off to a notified-body consultant.

21 protocols17 phasesNightly CIVVR + TraceabilityEvidence ZIP

Compliance posture — read this first: AiLabrix is research-use-only (RUO) software. The features above are compliance-ready by design but the platform is NOT certified for IVD diagnostic use. Certification (CE-IVD / 510(k)) requires a notified-body audit on the customer's organizational SOPs in addition to the technical artefacts AiLabrix ships. We help you build the dossier — you own the submission.

Workflow

Four steps. No code.

From raw file to signed report. AiLabrix guides you step by step, always showing what's happening under the hood.

01

Upload data

Drag CSV or Excel files. AiLabrix detects schema, assay type and suggests the most likely merges.

02

Launch the pipeline

26 agents run in parallel: profiling, QC, inference, figures, drafting. You see live status on a timeline.

03

Review and sign

Each gate asks for your OK. Contextual annotations, versioned comments, no emails lost in threads.

04

Export the report

Signed PDF, raw + intermediate data bundle, complete analysis log. All with SHA-256 hash.

AI intelligence layer

Two reasoning safeguards. Zero silent errors.

Most platforms stop at "the AI said so." AiLabrix goes further: every scientific interpretation is peer-reviewed by a second AI, and every LLM-backed agent can run two models in tandem to cross-check outputs before they reach the report. Two mechanisms, always transparent, always auditable.

Parallel reasoning · Tool-using verifier

Deep Think v2

K parallel candidates, balanced prove + refute, web grounding, multi-role synthesis.

Inspired by DeepMind's Gemini Deep Think, the scientific interpretation is generated as K parallel candidates (Aletheia role), each tested with balanced prompting — one pass arguing the result is correct, another arguing it is wrong. A tool layer runs inside the loop: code-assisted numeric verification against raw results plus web-grounded search (Brave → Google → DuckDuckGo fallback). An Advisor ranks the candidates and emits a structured verdict; a Colleague role challenges the winner with the strongest alternative hypothesis. Compute is log-scaled by level (L1 → L4).

  • Parallel thinking. K candidates generated concurrently (K=2 → 16) with distinct angles, not one-shot.
  • Balanced prompting. Every candidate is both PROVED and REFUTED — not just critiqued one-sidedly.
  • Tool-using verifier. Numeric claims checked against raw data in code; clinical claims grounded via Brave / Google / DuckDuckGo.
  • Multi-role. Aletheia generates & verifies, Advisor synthesises + scores, Colleague challenges with the strongest alternative hypothesis.
🧠 K parallel ⚖ prove + refute 🛠 code + web 🎓 multi-role
Multi-model validation

Dual AI

Two models cross-check each other. Every output signed.

One AI is smart. Two AIs that disagree and resolve are scientifically stronger. Dual AI lets you pair a primary model with a reviewer model — per agent — and pick one of two validation modes. Every output carries a SHA-256 hash and full provenance (which model wrote what, which revised what) in the report appendix.

Mode 1

Critique · Revise

Primary writes. Reviewer marks errors. Primary revises. Sequential, deepest quality.

Mode 2

Parallel · Synthesis

Both models reason concurrently. Primary merges the strongest claims. Fastest, diverse angles.

  • Per-agent toggle. Enable Dual AI only where it matters — from admin Settings → Agent Config.
  • 7 LLM stages supported. Figure QA, scientific interpretation, literature evidence, clinical relevance, executive brief, and more.
  • Mix providers. Anthropic Claude + OpenAI GPT + Ollama cloud — choose the best model per role.
  • Audit-ready provenance. Model names, output hashes and critique excerpts embedded in Appendix C.
⚡ 7 stages Claude · GPT · Ollama SHA-256 signed
Live demo

Watch it work on your data.

30 seconds are enough to see a clinical dataset turn into a signable report. No jupyter notebooks, no fragile R scripts, no lost Excel files.

  • Live timeline. See every agent working in real-time with structured logs.
  • Interactive gates. Stop, annotate, ask for a step to be re-run: the analysis waits for you.
  • Figure gallery. All generated scientific figures are exportable in high-res PNG/SVG.
  • Multi-language. English, Italian, Spanish, German, French already included.
Live demo
Virtual R&D lab

A complete research team. Running on your data.

AiLabrix replicates a real R&D laboratory as a software organization. 26 AI and Python agents, grouped in four divisions under a C-suite, pass the dataset along the same chain a human lab would: intake → statistics → science → quality. Each role is specialized, each handoff is logged, nothing skips steps.

C-suite · Executive
Executive Advisor
CEO · final executive brief, strategic synthesis (AI)
C-suite · Operations
Program Manager
COO · pipeline orchestration, gate coordination
F.1 · Data Operations

Data Operations Division

The bench team. Receives the raw dataset, detects schema and assay type, fixes missing values, runs exploratory analysis and checks chart readability before anything moves downstream.

🛡
Data Gate
Director · QC validation gate, human approval hook
📥
Data Profiler
Schema detection, delimiter, encoding, auto-merge
🧬
Assay Analyst
ELISA, qPCR, flow, NGS, chemistry, metabolomics, hematology — detection, reference ranges, units
Data Engineer
Cleaning, normalization, imputation, outlier flags
📈
Data Scientist
Exploratory analysis, descriptive stats, first figures
👁
Vision QA AI
Multimodal chart readability inspector (vision LLM)
CSV · TSV · XLSX Auto-schema Z-score · IQR Vision LLM
F.2 · Statistical Analysis

Statistical Analysis Division

The biostatistics desk. Chooses the right test based on distribution and sample size, applies multiple-comparison corrections, computes effect size and 95% CI, and halts if the data aren't powered for inference.

🧮
Method Validator
Test selection, normality & variance assumption checks
🚦
Capability Gate
n<30 halt guard, power estimation, safe stop
Stats Confirmer
t-test, Wilcoxon, ANOVA, BH/Bonferroni, effect size, 95% CI
Parametric · Non-param BH-FDR · Bonferroni Effect size Power gate
F.3 · Scientific & Medical

Scientific & Medical Division

The scientists' room. Turns numbers into a biomedical narrative, stress-tests it with peer review (Deep Think), pulls supporting literature, curates evidence and maps findings to clinical relevance.

🧑‍🔬
Aletheia AI
Deep Think v2 generator · K parallel candidates + prove/refute verifier
🎓
Advisor + Colleague AI
Deep Think v2 synthesis · ranks candidates + alternative-hypothesis challenge
🛡
Science Gate
Scientific ops review · human-in-the-loop approval
📚
Research Librarian AI
CRO · literature evidence, citations, prior art
🗂
Evidence Curator AI
Knowledge review · supporting vs contradicting evidence
🩺
Clinical Physician AI
CMO · clinical relevance, patient impact mapping
Deep Think v2 Dual AI ready PubMed-style evidence Clinical mapping
F.4 · Quality Assurance

Quality Assurance Division

The QA office. Runs compliance checks against ISO 15189 / GxP principles, assembles the append-only audit trail, generates the signable PDF and seals every artefact with a SHA-256 hash.

👤
QA Director
Director · QA orchestration and reviewer routing
Compliance Officer
CCO · ISO 15189:2022 & GxP principle checks
🧾
Audit Builder
Append-only audit trail, versioning, who-did-what log
📄
PDF Generator
Technical reporting · signed PDF with methods, figures, appendices
📑
QA Assembler
QA documentation · Appendix A/B/C assembly
ISO 15189:2022-aligned GxP SHA-256 seal Signable PDF
Python / deterministic agent LLM-powered agent (Dual AI compatible) 26 agents · 4 divisions · 1 C-suite
Native insights

Defensible statistics, publication-ready charts.

AiLabrix generates figures compliant with scientific journal standards. Every chart is signed with source dataset and tested hypotheses.

Between-group comparison

Boxplot + jitter · n=124 · p < 0.001

Time progression

Mean ± 95% CI · 12 weeks · arm A vs arm B

Concentration distribution (ELISA)

KDE · 3 cohorts · log scale

Agent contribution per run

Mean time per agent · last 50 runs
0
AI agents orchestrated
0
From CSV to average report
0
Reproducibility on same data
0
Supported languages
Use cases

Built for those who cannot afford a wrong analysis.

Research teams that need defensible, reproducible and fast results, without depending on a single data scientist.

Internal R&D labs

Corporate teams of 3-20 researchers running 10+ experiments per month who need to standardize analysis and reporting across different people.

"We halved the time between end-of-experiment and signed report. And we finally know how every number was obtained."

CROs and consultants

Those serving different clients on different datasets need an identical, certifiable workflow that reduces human error and validation effort.

"Every client wants the same report but on different data. With AiLabrix the pipeline is the same: only the input changes."

Bioinformatics & biotech

Research groups that must deliver clean analysis to clinical teams and regulatory affairs. Audit trail, versioning, hash on every artifact.

"Regulatory is happy. We're happy because we no longer spend weeks rebuilding 'how we calculated that mean'."

FAQ

Questions you'll have too.

Does my data stay mine?
Yes, with two important details. AiLabrix is designed for self-hosted deployment (Docker container on your infrastructure or private cloud). With a local LLM backend (Ollama), no data leaves your network. With an optional cloud backend (OpenAI or Anthropic), the statistical findings derived from your dataset are sent to that provider — the choice is explicit, configurable and every LLM call is logged with backend, model and token counts. All web traffic is encrypted over TLS. The database runs on a private network and is not exposed. Every administrative action is written to an append-only audit trail.
How does the 26-agent pipeline really work?
A LangGraph graph orchestrates 26 specialized agents: ingestion, schema-check, QC, normalization, descriptive stats, inferential test selection, multiple corrections, figure generation, report drafting, validation gates, signing. Each agent has a precise role, separate logs, and can be re-run independently for review.
Which data formats are supported?
CSV, TSV, Excel (.xlsx, .xls). Automatic detection of separator, encoding, schema and assay type (ELISA, qPCR, generic datasets). Supports multi-file merge on shared columns with interactive preview before confirming.
Is AiLabrix certified for ISO 15189, GxP or IVD use?
No. AiLabrix is currently Research Use Only (RUO) and has not undergone notified-body certification. The architecture is designed in alignment with ISO 15189:2022, ISO 14971, IEC 62304, 21 CFR Part 11 and IVDR Annex IX principles — end-to-end traceability, append-only audit trail, digital signing of reports, data and pipeline versioning, configurable validation gates — so that a future certification process can build on existing evidence. Current organizational compliance depends on your SOPs. See our Compliance status page for full details.
Do I need to know how to program?
No. The interface is drag-and-drop. If you know Python and want to extend the agents, you can: the project exposes an internal API. But the base flow (data → signed report) is completely no-code.
What's the difference vs writing an R or Python script?
An individual script is fragile: it gets lost, is not versioned, no one can replicate it in six months. AiLabrix gives you a shared, reproducible, signed pipeline with PDF reports on every run. The time you save is not in calculating the mean, it's in defending the mean in audit.
How much does it cost?
We are in early-adopter onboarding. For the first partner labs the pilot is free. Write us at [email protected] with two lines about your use case.
Can I try it on my data?
Yes. We prefer demos on real datasets (anonymized if needed): you really see if the result is useful in your context. Contact us at [email protected] to arrange a 30-minute onboarding.
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