Premise Bio · An AI agent that drafts coded ICSRs

AI for drug safety

Your team confirms or corrects the draft, instead of building each case from scratch.

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

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

J Immuno-Oncol · 2026 · case series

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

We describe a 64-year-old man with NSCLC on an anti–PD-1 antibody who developed Grade 3 immune-mediated hepatitis and immune-mediated colitis twelve days after cycle 4. Both improved off-drug and on corticosteroids.

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

Valid-ICSR triage · one report per patient

P1Not validno descriptor

P2Validthe case we follow

P3Separatethyroiditis · C.1.10.r

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

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

✓ Caused / prolonged hospitalisation fax + call

Disabling / incapacitating

Congenital anomaly

✓ Other medically important condition article

Possible duplicate match 0.9

Matches existing report US-PREMISE-2026-000492 on age, sex, country, drug, reactions, onset. Brand and batch are absent, so identity is not confirmed. Initials masked, not used as a key.

Draft · pending reviewerLink follow-upOpen new

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

Clinical source

On (anti–PD-1), 4 cycles. Concomitant .

12 days post cycle 4: , new .

Grade 3 and immune-mediated . CT: colonic wall thickening, normal liver.

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. Viral and autoimmune workup negative. Hospitalized 4 days, TEZOLIMAB discontinued, methylprednisolone started, recovering.

Coded · narrative drafted · 1 to confirm Send to QCEdit coding

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

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

Entry DSA-Associate-A → Review Reviewer-B · cannot edit the entry Agent flags only · no sign-off

Source of record

Hepatic panel: (ULN 40).

Discharge: verbatim diagnosis , not enterocolitis. CT shows colonic involvement only.

; onset .

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 Approve QCReturn to processing

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

Clinical + reference source

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

Hepatic trend: after discontinuation; .

Imaging: CT, normal liver. .

Confounder: concomitant , a recognised hepatotoxin.

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 Medical sign-offRequest follow-up

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) into your safety system (Argus, Veeva Vault Safety, ArisGlobal), yours or your provider's.
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

I'm Siddish, the founder. You'd work with me directly, on a pilot scoped to your acceptance criteria and your data.

Siddish, founder · 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.