Document Authoring
A regulatory document generated in Sanai from a template and the source data, with each claim cited to its source.
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Sanai at work
The 80-second film, then the product itself: from scattered versions and late-night email threads to a cited, review-ready first draft in days, not weeks.
See it on your own documents: we'll focus the demo on your process and priorities.
Product walkthroughs
See each part of the platform
Recordings of the product on real regulatory work: drafting, asking, reviewing and controlling documents.
Query Engine
A question asked across connected regulatory and clinical documents in Sanai, answered with the sources it came from.
Details and transcriptReview Tool
A drafted document checked claim by claim against its sources in the Sanai Review Tool.
Details and transcriptDocument Control
Document versions, changes and their traceability tracked in Sanai Document Control.
Details and transcript
Film transcript
What the film shows, scene by scene
The film tells its story in on-screen text, over music. Here it is in full, with the time each scene starts.
A submission outline
A Common Technical Document outline: nine modules, from administrative information and summaries through quality, nonclinical and clinical study reports to labeling and regional information. Total open sections: 510.
Late-night email threads
An inbox at 11:42 PM: “Re: Latest version?”, “Version 3.2_final?”, “Re: Track changes”, “Need source for Table 14”, “Re: Updated CSR”.
The document tracker
A tracker of Module 2, an IND and an NDA at versions v3.2, v1.6, v2.1 and v1.4, with statuses In Review, In Progress, Pending and Draft, each owned by a different team. Track changes pile up.
The problem
It’s slow, it’s expensive.
A draft under review
A clinical study report passage in track changes: the study was conducted in accordance with ICH guidelines; the safety and efficacy results showed a statistically significant improvement over baseline. A reviewer’s comment against the claim: “Source??”
Sanai
The Sanai platform: a query engine over your documents, automated authoring and review.
Upload the sources
Drag and drop your files, or browse. A protocol (PDF) uploads, then a statistical analysis plan.
Ingesting and analysing
Sanai reads the documents, extracts the key information, auto-tags and structures the data.
Choose a section template
Choose a CSR section template: Synopsis, Section 11: Efficacy results, Section 12: Safety results, Appendix 16: Patient listings. Draft section.
Drafting, with citations
Section 11: Efficacy results. “A total of 248 patients were randomized, and 241 completed treatment [1]. The primary endpoint was met, with a mean change from baseline of −1.2% [2].”
Every number has a source
Citation [1] opens its source: Table 14.1.1, Patient disposition. Randomized: 124 treatment, 124 placebo, 248 total. Completed: 121, 120, 241.
Consistency check
Patients randomized across two documents: the Synopsis says 248, Section 10: Study patients says 242. Count mismatch flagged. Open both to resolve.
Send for review
Draft, QC review, approval. Count corrected to 248. QC reviewer assigned. Route to QC.
The audit trail
09:12 Draft generated from template (Sanai). 09:40 Count mismatch flagged (Sanai). 09:52 Patient count corrected (author). 10:05 QC passed (QC reviewer). 10:30 Approved and signed (approver).
Time to first draft
Before: weeks one to four. After: first draft in days, not weeks.
Judgment over formatting
Writers focus on the science.
Faster submissions
Out the door sooner.
See it on your own documents
Book a walkthrough: 30 minutes, on your own documents. Book at sanai.ai.