How will you use iSAT today?
iSAT serves two roles. Your choice shapes what you see on the home page and which actions you can take. You can change it by signing out and back in.
Sign in
Use your @altioadvisory.com Google Workspace account.
Re-authenticate to sign
21 CFR Part 11 Sec. 11.100(b) requires a fresh credential check at the moment of signing. Click below to re-authenticate with Google; when the popup closes the verdict will resubmit automatically.
Re-authenticate with GoogleA safety workbench for the work that gets signed.
Pharmacovigilance for trials where a regulator, a committee, or an inspector will ask you to show your work.
“There is a regulator letter on my desk and it has 38 questions.”
Ingest the letter, your validated listings, the protocol, and the response template if the regulator included one. iSAT drafts a per-question response with inline citations. You edit. You sign.
“I’m working the morning triage queue and need to disposition each case.”
Same-day triage of inbound spontaneous reports, FAERS hits, and literature flags. iSAT classifies seriousness, resolves drug to ATC and reaction to MedDRA PT, and routes each case through the spine. You review, accept, and route into the recurring buffer.
“It’s time for this cycle’s weekly, monthly, or quarterly aggregate safety report.”
Aggregate cycles per ICH E2C(R2). iSAT collapses case-level mentions to per-PT counts, preserves quarter boundaries, and composes the section draft from your validated listings, protocol amendments, and literature references.
“The quarterly safety committee meets and the briefing isn’t assembled yet.”
Quarterly safety committee briefing in narrative prose. iSAT tags benefit and risk signals, preserves sponsor versus data voice, and resolves drug and PT inline. The pack reads the way a safety physician writes it; the audit chain still hangs underneath.
“Something else came up and I need to look at the dataset right now.”
Free-form scoped surveillance for the “anything else we haven’t heard about” cadence. Type the question, optionally scope it to a compound or PT, get a narrative back with the supporting cases inline and any uncited clinical claims flagged.
HA RFI Response · EMA-2026-0314 · 14 March 2026
Let’s draft the response to EMA’s letter.
You give iSAT your sources. The router classifies each one and runs the appropriate parser. Drop anything iSAT understands: schema-strict XML, semi-structured PDFs, tabular listings, or scanned letters. If the regulator included a response template, drop that too; iSAT will follow it. If not, iSAT falls back to a defensible default opening with “The sponsor acknowledges the consideration…”
Drop your sources here
or
iSAT classifies each file on receipt. No pre-sorting needed.
Sources received (5)
All checksums verified against the Argus export manifest.All required source classes received. iSAT has the letter (Tier B), the validated listings (Tier C), and the protocol (Tier B). The response template (Tier B, optional) is also present. The Tier A supplemental CIOMS form will be cross-referenced where the letter touches case-level events.
iSAT will not begin drafting until all required tiers are present and the listings checksum matches the export manifest from Argus. Partial drafts are not produced from partial evidence. The audit chain depends on it.
Reading your sources.
About 90 seconds. We name what we read.
- Routing each source to its tier. 2 PDFs (Tier B), 1 spreadsheet (Tier C), 1 XML (Tier A), 1 template (Tier B).
- Identifying the regulator and the letter’s date and reference.Tier B
- Extracting each consideration in the letter. 38 found.Tier B
- Indexing the validated listings. 680 subjects, 6 tables, checksum verified against the Argus export manifest.Tier C
- Parsing the protocol. Endpoints, populations, stopping rules, and dose-modification tables located.Tier B
- Mapping each consideration to the relevant listing rows and protocol sections.
- Drafting per-consideration responses with inline citations. Following the EMA response template you uploaded.
EMA-2026-0314 · 38 considerations · 0 accepted
Response to Request for Information
European Medicines Agency · Ref EMEA/H/C/0049871/RFI/0001 · 14 March 2026
- Prepared by
- Altio · Study ONC-2024-019 · HORIZON-2B (Aprivazumab)
- Reviewer
- …
- Considerations
- 38 accepted
- Sources
- EMA letter · Argus listings 2026Q1 · Protocol v4.2 · CIOMS Form I (supplemental)
- Evidence chain
- Verified · 247 citations resolved
I have reviewed each of the responses prepared above. The drafts reflect the validated subject listings and the current study protocol as cited. Where I have edited a draft, the edit represents my clinical judgement and supersedes the original.
I am submitting this package as the responsible safety physician for the above-referenced study.
…
…
Package binding (SHA-256)
…
…
Daily triage · 2026-06-25
Today’s queue. Disposition each case before you stand up.
Same-day triage of inbound spontaneous reports, FAERS hits, and literature flags. Click a row to read the case detail, see the spine trace, and route the narrative through the daily-path normalizer.
| Priority | Report ID | Source | Drug | MedDRA PT | Seriousness | Age | Sex | Country | Onset |
|---|
Recurring report · weekly / monthly / quarterly cadence
PBRER section 6.5 - cumulative safety.
Aggregate framing per ICH E2C(R2). iSAT collapses case-level mentions to per-PT counts, preserves quarter boundaries, and composes the section from your validated listings, protocol amendments, and literature references.
Contributing sources
Safety committee briefing · quarterly safety committee
Safety Review Board, 15 April 2026.
Narrative prose for the safety committee. iSAT tags benefit and risk signals, preserves sponsor versus data voice, and resolves drug and PT inline so the pack reads the way the safety physician writes it.
Agenda
Record verdict
Electronic Signature Receipt
- Signed by
- Date / time
- Verdict
- Meaning
- Reference (Report ID)
- Reference hash
- Signature ID
- Record binding (§11.70)
-
SHA-256 of the signed case payload, bound to the e-signature per 21 CFR Part 11 Sec. 11.70.
Raw audit envelope
Audit log
Most recent events. The chain is verified on every read.
Tip hash:
| When | Actor | Action | Subject | Outcome |
|---|
Event detail
Admin console
Provisioned users and tenant metadata. Audit log on the next tab.
Tenant
- Tenant ID
- —
- State backend
- —
- Users
- —
- Audit events
- —
- Audit tip hash
—
Users
| Display name | Role |
|---|
No users provisioned yet.
The engine room.
Every step of this demo is backed by the same nine leaves you see here. Try the spine yourself.
Try an ingestion
Paste a snippet of a CIOMS report, an RFI letter, or a listings note. The router classifies the tier; the spine archives, anonymizes, normalizes, indexes.
Try a retrieval
Hybrid retrieval. KG + vector + keyword fused via reciprocal-rank. Per-mode scores are returned so you can see how each leaf contributed.