Stop losing study time to data cleanup, report drafting, and last-minute QC.

Preclinical Studio gives an AI workspace for raw-data processing, scientific writing, QA/QC review, and traceable evidence, AI drafts and checks the repetitive work; scientists keep the judgment, review, and approval.

app.xynx.ai / General Tox Studio / XM-441 Virtual SD Active
Ask the Virtual SD, or drop a file…
XM-441 registered chapter-drafter running evidence-linker queued
Compliant with· FDA 21 CFR Part 58· OECD GLP Principles· ICH M10· ISO 27001· 21 CFR Part 11· EU GLP Directive 2004/10/EC·
60%Reduction in report production time
9+Virtual labs across preclinical study types
100%Audit-trail coverage on every agent action
0Unsourced claims — every conclusion traced
A continuous study lifecycle

From protocol intake to inspection-ready report

From day one, a Virtual SD and six specialist agents work inside the study — so protocols, data, drafts, QC findings and reviews stay connected throughout, instead of waiting on scarce experts to review scattered files at the end.

AI handles the repeatable work. Experts make the scientific calls. The system preserves the evidence.

Stage 01 of 06

Study Intake

Virtual SD

Builds the study operating map from protocols, raw files, templates, timelines, review tasks, and delivery expectations. It links materials to study context, identifies missing or outdated inputs, and creates the ontology, evidence structure, and document relationships that other agents work from.

Before2-3 daysSD / PM manually reads protocol, sorts files, checks missing materials
Preclinical Studio
After< 5 minWorkspace, material map, status tracker created on upload
Stage 02 of 06

Curate

Data Curator

Turns raw files, Excel sheets, tables, figures, protocol fields, and extracted facts into reusable study assets. Each asset keeps source traceability, version context, and downstream links to analysis, writing, QC, and evidence review.

Before1-2 specialistsRepeated cleanup before every analysis, draft, QC round, and client revision
Preclinical Studio
AfterReusable assetsCleaned, structured, source-linked data objects ready for downstream work
Stage 03 of 06

Analyze

Statistical Analyst

Checks analysis logic, endpoint consistency, statistical outputs, trend interpretation, and whether results support intended conclusions. Instead of waiting for final review, analysis risks are flagged while tables, figures, and narratives are still forming.

BeforeLate reviewStats issues found after tables, figures, and draft text already diverge
Preclinical Studio
AfterEarly flagsEndpoint, trend, and logic issues surfaced before they become rework
Stage 04 of 06

Draft

Scientific Writer

Creates living scientific drafts from confirmed data, study context, statistical findings, and expert-approved conclusions. Narratives, summaries, deviation notes, and response text stay linked to source data, evidence objects, and review status.

Before$90k+ writerExperts rebuild context from files, comments, prior versions, and scattered QC notes
Preclinical Studio
AfterEvidence-linkedDraft sections stay connected to data, claims, comments, and source evidence
Stage 05 of 06

QC

QA Reviewer + QC Specialist

QA reviews workflow completeness, evidence-chain integrity, claim support, narrative quality, unresolved risks, and readiness. QC checks numbers, units, tables, references, terminology, formatting, cross-section consistency, and version alignment throughout the workflow.

BeforeEnd-stageQA/QC catches issues when fixes are slow and delivery dates already exposed
Preclinical Studio
AfterEmbedded QCIssues caught during the study, reducing late rework and review cycles
Stage 06 of 06

Evidence

Regulatory Specialist + Virtual SD

Tracks regulatory expectations, evidence gaps, audit trails, human confirmations, and XAI evidence packages as the study progresses. The final package reflects the real work history, not a last-minute reconstruction of why the report can be trusted.

BeforeLast-minuteAudit materials, rationale, and evidence trails rebuilt after the work is done
Preclinical Studio
AfterInspection memoryEvidence, decisions, review records, gaps, and confirmations accumulate during the study
BenchTeam · your virtual study team

BenchTeam: One Virtual SD. Six Specialist Agents.

Together, they replace the expensive part-time expert functions every CRO needs but cannot always staff on demand.

One Virtual SD

Virtual Study Director

Coordinates the study workflow, tracks status, manages versions, routes issues across agents, and prepares the package for human sign-off.

  • Routes issues, closes the loopRoutes issues across agents, follows every review to closure, and prepares the study package for human confirmation and delivery.
  • Never replaces the Study DirectorKeeps the work organized so your human SD can focus on scientific judgment, quality responsibility, and final sign-off.
Agent 01 of 06
Data Curator
Structures the data

Turns protocol information, raw files, tables, figures, and experimental data into traceable study assets by cleaning, structuring, converting, and summarizing them.

Agent 02 of 06
Statistical Analyst
Checks the analysis

Reviews analysis logic, statistical outputs, endpoint consistency, trends, and whether results support the intended scientific conclusions.

Agent 03 of 06
Scientific Writer
Writes the report

Turns experimental data, study context, evidence, and confirmed conclusions into clear, professional, delivery-ready scientific documents.

Agent 04 of 06
QA Reviewer
Reviews before sign-off

Reviews workflow completeness, evidence chain integrity, claim support, narrative quality, unresolved risks, and delivery readiness.

Agent 05 of 06
QC Specialist
Checks consistency

Checks data, tables, references, numbers, units, terminology, formatting, cross-section consistency, and version alignment.

Agent 06 of 06
Regulatory Specialist
Tracks the rules

Tracks relevant OECD, FDA, ICH, CDE, and regional expectations, identifies evidence gaps, and prepares regulatory checklists and audit/XAI packages.

Product scenarios

Built for the moments that actually matter

The moments in a study where the cost is real — and where a Director changes the day. Expand any scenario to see it in the product.

“The experiment wrapped weeks ago. The report still isn’t written.”

Preclinical Studio starts QC and evidence assembly the day study data arrives — so the report isn’t waiting for someone to manually reconcile protocol, raw data, figures and conclusions weeks later.

  • QC and evidence checks start the day study data lands — not at write-up
  • Protocol, raw data, figures and conclusions reconciled continuously
  • No multi-week manual reconciliation before the report can begin
QC & Evidence · XM-778Running · data day 1
XLS
tk_xm778_groups1-4.xlsx
received 09:14 · auto-QC started same day
Live
QC & evidence assembly as data lands — not at write-up
Data integrity
Pass ✓
Figures bound
12 / 12
Tables checked
8 / 8
Unit consistency
OK ✓
Evidence gaps
1 flagged
Report readiness
96%
Specialist Queue · XM-7784 tasks routed
Routine checks → digital specialists
Senior scientists keep judgment, interpretation and sign-off
1
Data integrity checks
Ranges, outliers and missing values verified
Done
2
Table reconciliation
Cross-checking tables against source datasets
Active
3
Figure references
Matching every figure call-out to its asset
Active
4
Unit consistency
Normalising units and terminology across sections
Active

“Your best experts are stuck reconciling tables.”

Data checks, table reconciliation, figure references, unit consistency and repeated template work move to digital specialists — while senior scientists focus on judgment, interpretation and sign-off.

  • Routine, high-liability checks handled by digital specialists
  • Senior scientists keep judgment, interpretation and sign-off
  • Less low-joy template work, fewer manual reconciliation errors

“The auditor points at one sentence. Where did this number come from?”

Every claim is linked to its source data, calculation, figure, reviewer action and audit trail — giving QA teams and sponsors a defensible path from conclusion back to evidence. Select a highlighted conclusion to inspect its source.

XM-441 · Final Report · §8 Toxicology SummaryTraceable
Excerpt · Conclusions

Under the conditions of this 13-week study, across all dose groups. Body-weight gain was , correlating with minimal hepatocellular changes. Based on the overall profile, .

Each highlighted claim is bound to its evidence — select one to inspect the source.
Evidence · E-1Verified
Source · In-life clinical observations

Daily mortality & clinical records

Mortality conclusion traces to the complete in-life observation log — twice-daily checks across all 60 animals for the full 13-week dosing period.

dataset · in_life_obs.csv · 60 animals
GroupDoseNMortality
G1 Control0150 / 15
G2 Low100150 / 15
G3 Mid300150 / 15
G4 High1000150 / 15
QC passedSD confirmedaudit · v1.2
Source · Body-weight dataset + Figure BW-3

Group mean body weight · week 13

The high-dose reduction traces to the body-weight dataset and its derived figure. Group G4 shows a statistically significant decrease versus control.

dataset · body_weight.xlsx — fig BW-3
GroupDoseMean BW (g)vs Ctrl
G1 Control0412
G3 Mid300404-1.9%
G4 High1000368-10.7%*
P < 0.05Flagged findingaudit · v1.2
Source · Integrated NOAEL determination

NOAEL · 300 mg/kg/day

The NOAEL traces to the integrated review across endpoints — body weight, clinical pathology and histopathology — with the high dose excluded on the flagged body-weight finding.

derivation · noael_review.json · 4 endpoints
DoseBWClin-pathCall
100OKOKNOAEL
300OKOKNOAEL
1000-10.7%AdaptiveLOAEL
Cross-endpointSD signedaudit · v1.2
Draft vs delivery

Beyond an 80% Draft.
Built for Expert-Signed Delivery.

General-purpose AI is good at drafting fast. Regulated R&D requires something deeper: claims tied to source evidence, deterministic calculations, human review gates, version-controlled workflows, and audit packages ready for export.

01
Every number has a source.
02
Every conclusion has a reviewer.
03
Every delivery has an audit trail.
Explainable AI — try it

Click any highlighted claim in this report excerpt. The panel shows why the model wrote it, the data it rests on, and where a human still decides — the heart of the XAI review, on its own.

preclinical.studio / review · explainable-ai
Built for GLP

Not adapted for GLP. Built for it.

Every architectural decision was made with GLP inspection readiness as the first constraint — not an afterthought.

Ref: OECD ENV/MC/CHEM(98)17

OECD GLP Principles

Built around Principle 8. Aligned to 1–10.

Study Plan structure, personnel records, amendment procedures, and audit trail requirements are mapped directly to OECD GLP Principles. Not interpreted. Not approximated. Mapped.

GLP Principles 1–10 · Full alignment
Ref: 21 CFR Part 11 — FDA

FDA 21 CFR Part 11

Part 11 isn't a checkbox. It's the architecture.

Closed system controls, granular access permissions, cryptographic audit trail, and e-signature workflows are built into the platform foundation — not added on top of a general tool.

eSig · Closed system · Audit trail
Ref: Directive 2004/10/EC

EU GLP & Data Residency

Your data doesn't leave your region.

US, EU, and APAC deployments available. Data residency is enforced at the infrastructure level — not configured per request. No cross-border transfer without explicit authorization.

US · EU · APAC · Enforced at infra
Voices from the lab

What burns the budget isn't the writing. It's the re-checking.

The experiment finishes — and the real grind begins. Here's what changed once directors, QA leads and sponsors put the report loop on Preclinical Studio.

"The experiment used to end and the report never would — re-reconciling data scattered across a dozen places, over and over. Now it auto-drafts from the confirmed protocol data and every number carries its own evidence. The report lands in days, not weeks — and the payment lands with it."

Unlocked the ~60% of contract value tied to the report
Dr. Julien Mercier
Dr. Julien Mercier
VP, Toxicology Operations · mid-size CRO

"It's high-liability, low-joy work, and the people who can do it are expensive and scarce. The platform drafts the data-woven sections and runs QC before anything leaves the building, so my specialists stop reconciling and start reviewing — and reports clear the three-party check the first time."

6–8 week revision cycle collapsed · capital freed
Dr. Lena Brandt
Dr. Lena Brandt
Director of QA & Medical Writing · GLP facility

"Everyone asks whether a stronger model just replaces this. It won't — a bigger model writes faster, it doesn't make a report defensible. Preclinical Studio's XAI shows why every sentence is trustworthy, and controlled recursive learning turns each real project into a reusable asset: higher QC pass rates, less rework, faster client fit. That compounding is the moat."

Every project compounds — the moat widens with use
Dr. Anders Holm
Dr. Anders Holm
CTO · CRO group, 12 facilities
Pricing

Choose the scale that fits your lab

All plans include the full study-type catalogue. The difference is activation depth, governance tier and Credits volume.

Starter
$79/ moSave 10%

Evaluate the workflow with non-production studies and demo data.

  • Full study-type catalogue visible
  • Demo Profile + Archive Mode
  • Limited Demo Credits — non-production only
Start free 14-day trial
Most popular Professional
$599/ moSave 10%

Team-level production. Activate your reporting pipeline.

  • Up to 5 Active Profiles
  • Standard Credits + top-up
  • QC + evidence chain + multi-user
Get started
Enterprise
$2,999/ moSave 10%

Company-wide standards. Scale activation across departments.

  • Unlimited Active Profiles
  • Large Credits pool + tiered discounts
  • QA Review Pack + cross-project audit
Talk to sales
Private Deploy
Custom

Data never leaves your network. Maximum compliance and regulatory fit.

  • On-premise / air-gapped deployment
  • Deep LIMS / ELN / QMS integration
  • SLA + on-site / remote co-build support
Contact us

All plans include access to the full study-type catalogue. Production capability requires separate activation.

Study-type activation fees are tiered by complexity: Type A $500 · Type B $1,000 · Type C $2,500 · Type D $7,500+

In Silico Workforce

See how one real study becomes audit-ready

We will show how the Virtual SD sets up the study, activates digital specialists, builds the evidence chain and prepares the QA review package.

Request a private demo
No production data required · we reply within one business day