AI for drug safety

01 Literature intake & triage

From a journal article to a review-ready ICSR.

A published case series lands in the inbox. The agent reads the page itself and boxes what it found.

C.1.8.1 LIT-2026-00318 Literature item Clock starts once the ICSR is valid Owner SR

SRC Publication review · click a finding to see it boxed on the page

Supplied publication · J Immuno-Oncol · 2026 · case series Case narrative Table 2

Immune-mediated hepatitis and colitis with anti–PD-1 therapy

Case narrative

Patient 2 was a in the United States with NSCLC receiving for four cycles, with concomitant atorvastatin 40 mg. he developed and , with scleral icterus and 5–6 watery stools per day.

Table 2Patient-level findings

Patient 1 (pneumonitis, no descriptor) and Patient 3 (thyroiditis) are reported separately.

Valid-ICSR triage · one report per patient

P1Not validno descriptor

P3Separatethyroiditis · C.1.10.r

✓ Identifiable reporter ✓ Identifiable patient ✓ Suspect drug ✓ At least one reaction

P2TEZOLIMABHepatitis + colitis

Seriousness Serious · proposed E.i.3.2 a–f

Six criteria, at event level. Two apply; click a ticked one to see it on the source.

Results in death

Life-threatening

Disabling / incapacitating

Congenital anomaly

Possible duplicate match 0.9

Matches existing report US-PREMISE-2026-000492 on age, sex, country, drug, reactions, onset. Brand, batch, and a unique patient identifier are absent, so identity is not confirmed.

Draft · pending reviewer

E.i / F.r / G.k Publication to coding · click any value to see its source

Publication excerpt

Case narrative patient, treatment, reactions Table 2 labs, imaging, admission, outcome

The article reports (anti–PD-1), 4 cycles, with concomitant .

12 days post cycle 4: , new .

Grade 3 and immune-mediated . The publication reports colonic wall thickening and a normal liver on CT.

ALT U/L T.bili mg/dL

Coded draft

Supporting · under the parent diagnoses, not double-counted

WHODrug

H.1 Narrative draft · every clause source-linked

A 64-year-old male with NSCLC received TEZOLIMAB 200 mg IV every 3 weeks for 4 cycles. Twelve days after cycle 4 he developed Grade 3 immune-mediated hepatitis (ALT 612 U/L, total bilirubin 4.8 mg/dL) with scleral icterus, and immune-mediated colitis with 5–6 watery stools per day. CT showed colonic wall thickening and a normal liver. He was hospitalized for 4 days. TEZOLIMAB was discontinued, corticosteroids were started, and both reactions improved.

Coded · narrative drafted · 1 to confirm

ASKU Concomitant atorvastatin, action taken: asked but unknown. 1 follow-up query logged, not guessed into a value.

QC Field vs publication · entered by one person, checked by another

Entry DSA-Associate-A → Review Reviewer-B · corrections retain the audit trail Independent QC · field by field

Publication reread in full Fields checked against evidence Narrative chronology rechecked

Publication evidence

Patient 2 is reconstructed across the .

The article reports (ULN 40).

Verbatim diagnosis: , not enterocolitis. CT shows colonic involvement only.

; onset .

The reported course is off-drug and on steroids: , outcome .

QC checklist

DEDUP / E2B Reconcile & carry forward · nothing closed quietly

Duplicate search returns one match (0.9) to the spontaneous report. Read as the same case via two routes, so it is linked, not duplicated. E2B(R3) conformance passes: reporter qualification, country, and seriousness present.

QC passed · 1 open follow-up

Concomitant atorvastatin stop/continue status still unresolved: the follow-up query stays open, the case is valid without it.

RSI / WHO-UMC Events vs reference safety info · click any value to see its source

Publication + reference safety info

RSI · CCDS (v7.0): and are listed reactions.

Publication: Hepatic trend after discontinuation; .

Publication: CT, normal liver; .

Publication: Concomitant , a recognised hepatotoxin; no rechallenge reported.

Assessment · proposed

Expectedness vs RSI

Seriousness

Causality · TEZOLIMAB → hepatitis

Dechallenge Positive · confounded by steroids Rechallenge Not done

SIGN-OFF Proposed assessment · the physician decides

SeriousnessSerious

CriteriaHospitalization + IME

ExpectednessListed vs RSI

CausalityProbable proposed

Hy's lawALT ≈15× ULN + bilirubin ≈4× ULN meets the lab criteria, not confirmed Hy's law: cholestasis and other causes not yet excluded. Flagged for the physician.

ReportingReportability is region- and status-specific. Flagged for confirmation per product status and authority; the agent does not assert it.

e-sign Meaning: Approved · locks v0.2 · audit: causality Unknown → Probable, pending signature

Drafted · sign-off pending

How it works with your team

The agent drafts. Your team decides.

The agent is validated software that proposes. Your qualified reviewer decides, signs, and stays the author of record. It never writes to your safety system.

Draft quality is measured against a clinically labeled gold set, safety-critical errors held to the tightest tolerances, and reported before any efficiency claim. Target: up to ~60% lower cost per case, at held quality, proven on your data in a pilot.

Built for regulated drug safety

The questions your safety, quality, and security teams will ask.

Designed to support 21 CFR Part 11 EU Annex 11 ICH E2B(R3) GVP Module VI GAMP 5

Integration

Drafts E2B(R3) for import into Argus, Veeva Vault Safety, or ArisGlobal.
No new tool, no migration. The agent never writes to the system of record.
Your data and audit packets export any time.

Validation

An AI that drafts into a safety record is GAMP 5 Category 5, and validated that way.
One change-controlled config: model, prompts, MedDRA and WHODrug versions. Changes trigger re-qualification.
We supply the qualification evidence; you validate for your intended use.

Security

AWS and Amazon Bedrock in your tenant and region, encrypted in transit and at rest.
Reads are scoped, logged, least-privilege, or against an export you provide. No standing write access.
No training on your data. DPA, sub-processor list, SDEA, AWS BAA.

Audit trail

Append-only log of every action, each value linked to its source.
Model and config version stamped into each record's packet.
Part 11 e-signature: identity, UTC timestamp, meaning, tamper-evident binding.
The binding ICSR signature is applied in your system after import.

Who you'd work with

We're Siddish and Ashwanth, cofounders. You'd work with us directly on a pilot scoped to your acceptance criteria and your data.

Siddish and Ashwanth, cofounders · hello@premise.bio

Put it on a case of yours.

Book a call Request the evaluation pack

The pack: a security overview, the validation plan, a DPA and sub-processor list, and a sample audit packet.