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.
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.
Together, they replace the expensive part-time expert functions every CRO needs but cannot always staff on demand.
Coordinates the study workflow, tracks status, manages versions, routes issues across agents, and prepares the package for human sign-off.
Turns protocol information, raw files, tables, figures, and experimental data into traceable study assets by cleaning, structuring, converting, and summarizing them.
Reviews analysis logic, statistical outputs, endpoint consistency, trends, and whether results support the intended scientific conclusions.
Turns experimental data, study context, evidence, and confirmed conclusions into clear, professional, delivery-ready scientific documents.
Reviews workflow completeness, evidence chain integrity, claim support, narrative quality, unresolved risks, and delivery readiness.
Checks data, tables, references, numbers, units, terminology, formatting, cross-section consistency, and version alignment.
Tracks relevant OECD, FDA, ICH, CDE, and regional expectations, identifies evidence gaps, and prepares regulatory checklists and audit/XAI packages.
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.
“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.
“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.
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, .
Mortality conclusion traces to the complete in-life observation log — twice-daily checks across all 60 animals for the full 13-week dosing period.
| Group | Dose | N | Mortality |
|---|---|---|---|
| G1 Control | 0 | 15 | 0 / 15 |
| G2 Low | 100 | 15 | 0 / 15 |
| G3 Mid | 300 | 15 | 0 / 15 |
| G4 High | 1000 | 15 | 0 / 15 |
The high-dose reduction traces to the body-weight dataset and its derived figure. Group G4 shows a statistically significant decrease versus control.
| Group | Dose | Mean BW (g) | vs Ctrl |
|---|---|---|---|
| G1 Control | 0 | 412 | — |
| G3 Mid | 300 | 404 | -1.9% |
| G4 High | 1000 | 368 | -10.7%* |
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.
| Dose | BW | Clin-path | Call |
|---|---|---|---|
| 100 | OK | OK | NOAEL |
| 300 | OK | OK | NOAEL |
| 1000 | -10.7% | Adaptive | LOAEL |
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.
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.
Every architectural decision was made with GLP inspection readiness as the first constraint — not an afterthought.
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.
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.
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.
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"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"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 useAll plans include the full study-type catalogue. The difference is activation depth, governance tier and Credits volume.
Evaluate the workflow with non-production studies and demo data.
Team-level production. Activate your reporting pipeline.
Company-wide standards. Scale activation across departments.
Data never leaves your network. Maximum compliance and regulatory fit.
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+
We will show how the Virtual SD sets up the study, activates digital specialists, builds the evidence chain and prepares the QA review package.