Pharma · Medical Writing · Biostatistics

Draft the submission without exposing the trial.

CSRs under ICH E3, protocols, SAPs, TLFs and CTD Module 2 summaries — built on sponsor-confidential, often unblinded trial data that can't be handed to a public model. Untraceable cloaks product names, patient data and endpoints before the AI sees them, so medical writing and biostatistics teams get frontier AI without touching submission integrity.

The suite, in your workflow

Every tool, mapped to the documents you produce.

The same eight-tool suite that runs on patent-pending cloaking — pointed at clinical and regulatory writing and the analyses behind it.

Cloaking

Cloak product names, trial identifiers, patient-level data and endpoints before any AI sees them.

Output: Sponsor-confidential and blinding-sensitive values replaced with informative cloaks.

VaultScribe

Draft and rewrite CSR sections (ICH E3), protocol synopses, CTD Module 2 summaries and safety narratives on cloaked data.

Output: Submission-grade prose fluent in regulatory and biostatistics conventions.

VaultStat

Generate pseudo-IPD and auto-produce statistical code on cloaked data behind your TLFs — survival, descriptive statistics, epidemiology analyses and more.

Output: A statistical analysis plan and analysis code, run for you in a protected environment where the AI never sees your data — and never sees the results.

VaultDelphi

Converge multiple models on high-stakes wording — safety-signal interpretation, benefit-risk language.

Output: A report and narrative for grounded decisions — a Delphi-style consensus reached with AI, on cloaked data — giving you the evidence, the references and a traced decision narrative you can defend.

Blueprint

Start CSRs, protocols, SAPs and CTD modules from compliance-aware structure instead of a blank page.

Output: Start from pre-filled templates — manuscript draft, SAP draft, CSR shell, protocol synopsis — built to your local guideline requirements, with AI instructions pre-generated to accelerate development. Available today for Canada: 1,000+ documents, including 50+ guidelines and local best-practice publications.

VaultCanvas

Automate TLF-adjacent and summary reporting from a single Excel source of truth.

Output: (1) Connect your Word report directly to Excel so it auto-updates with AI — the AI sees no data. Ideal for living reports and summaries you refresh often, without the recurring-update hassle.(2) Generate an interactive model or deck from the PowerPoint version at the click of a button — skip time-consuming HTML/UI development and use your Excel as the interface.

VaultChat

Ask quick questions across a cloaked SAP, protocol or CSR shell.

Output: Fast frontier-model answers with every value cloaked before it leaves.

VaultAudit & Untraceable Protocol

Certify cloaked AI use for regulatory integrity; keep an audit trail of every value, cloak and submission.

Output: A permanent, shareable certification retained in your own SharePoint — cloaks only, never raw values.

The Grounding Codex

Fluent in regulatory and biostatistics — by design.

VaultScribe writes on Hybrid RAG plus a Grounding Codex — a human-curated source corpus where critical guideline information is organized to augment AI intelligence while remaining human-anchored: AI-drafted, then reviewed and iterated against direct expert judgment until every entry holds up, not machine-scraped and not left unchecked. Our published multi-model work shows this grounding measurably lifts writing quality and reduces hallucination; that study was run on an HEOR health-technology-assessment knowledge layer, and the same human-anchored approach extends the Codex to regulatory and biostatistics conventions.

Available in Canada · in development for the US & Europe

Tracing every sentence back to the SDTM/ADaM datasets and source documents behind it — so a reviewer can follow any statement in a CSR or summary to its underlying data for submission-grade traceability. Available today for Canada; in active development for the US and Europe.

The evidence

We measured it, and published the numbers.

Cloaking keeps the writing quality

In a controlled comparison of de-identification methods, Semantic Cloaking retained 91–94/100 writing quality against a 96/100 baseline — while censorship fell to 42 and substitution to 18. The method that protects the data keeps the prose usable.

Read the preprint — Tremblay & Harricharan (2026) →

Field grounding lifts quality

Across four models, grounding in a curated field knowledge layer improved mean writing quality +2.4/100 (up to +10.0 on writing), judged by a blinded AI Delphi panel — demonstrated on an HEOR/HTA layer, the same method the Codex applies to regulatory writing.

Read the RAG / knowledge-layer preprint →

See all publications →

Give your writers frontier AI — without touching submission integrity.

See it on your own CSR, protocol or SAP workflow — the AI never sees a confidential value.

Book a demo →Explore the tools