AI case processing for pharmacovigilance

Every adverse event, ready for medical review in minutes.

Expedita reads every source, from call notes to journal articles, and turns it into a complete, coded, E2B(R3)-ready case. Your safety team reviews and signs. The 15-day clock stops being the bottleneck.

See a sample case How it works

EXP-2026-004812Sample case — synthetic data

Source: Call-center transcript, Spanish
Validity: 4 of 4 minimum criteria met
Suspect product: Velnorab 40 mg tablets
Event (MedDRA PT): Drug-induced liver injury+ Jaundice, Fatigue
Seriousness: Hospitalizationproposed
Expectedness: Unlisted vs. reference safety informationproposed
Reporting: 15-day expedited
Day 0: 2 Nov 2026
Due: 17 Nov 2026

StatusAwaiting medical review

The problem

Case volumes keep rising. Headcount can't.

Intake is still typing

Processors read, triage, deduplicate and re-key every report by hand before anyone assesses it medically.

The clock doesn't wait

Serious unexpected cases are due within 15 calendar days of Day 0. Late submissions become inspection findings.

Literature never stops

Weekly screening of global and local literature means thousands of abstracts, most of them irrelevant.

Your experts should be assessing cases, not typing them.

Workflow

From any source to a submission-ready case.

Intake

Calls, emails, medical information, partner feeds, social and literature, in 40+ languages.

Validity & triage

Four minimum criteria, Day 0 assignment, duplicate detection against existing cases.

Coding

MedDRA for events, WHODrug for products, dosing, dates and lab values extracted with the source sentence attached.

Assessment proposals

Seriousness, expectedness against your reference safety information, causality — each with its reasoning.

Narrative

Drafted in your company's narrative conventions, ready to edit.

Submission-ready

E2B(R3) case routed to your safety database and regulatory clock.

✓

Human review

Safety professional reviews and signs

Intake

Calls, emails, medical information, partner feeds, social and literature, in 40+ languages.

Validity & triage

Four minimum criteria, Day 0 assignment, duplicate detection against existing cases.

Coding

MedDRA for events, WHODrug for products, dosing, dates and lab values extracted with the source sentence attached.

Assessment proposals

Seriousness, expectedness against your reference safety information, causality — each with its reasoning.

Narrative

Drafted in your company's narrative conventions, ready to edit.

✓

Human review

Safety professional reviews and signs

Submission-ready

E2B(R3) case routed to your safety database and regulatory clock.

Expedita proposes. Qualified safety professionals review, edit and sign every case before it leaves the building.

Sample case

Every field shows where it came from.

EXP-2026-004812 · Call-center transcript (ES → EN)Sample case — synthetic data

Source

English translation · original Spanish retained

Agent: Medical information line, how can I help you?

Caller: I'm calling about my mother, she's 58^S1. I'm her daughter^S2. She has been taking Velnorab 40 mg, one tablet a day^S3, for about six weeks^S4.

Last week her eyes and skin turned yellow^S9 and she was very tired^S10 — the doctors said it was liver damage from the medicine^S5. She was admitted to hospital on 30 October^S6.

They stopped the Velnorab^S7, and her liver values are improving^S8 now.

Agent: Thank you. May we contact her treating physician for follow-up?

Extracted case

Patient

SexFemalesource S1

Age58 yearssource S1

Reporter

TypeConsumer — relative (daughter)source S2

Suspect product

ProductVelnorab 40 mg tabletssource S3

Route / frequencyOral, once dailysource S3

Start date~18 Sep 2026source S4

Action takenDrug withdrawnsource S7

Event

MedDRA PTDrug-induced liver injurysource S5

MedDRA PTJaundicesource S9

MedDRA PTFatiguesource S10

Onset~Late Oct 2026source S5

OutcomeRecoveringsource S8

Seriousness

CriterionHospitalizationproposedsource S6

Dechallenge

ResultPositivesource S8

Narrative draft

proposed

This spontaneous report was received from a consumer (the patient's daughter) via the medical information call center on 2 Nov 2026. A 58-year-old female patient received Velnorab 40 mg tablets orally once daily from approximately 18 Sep 2026. In late October 2026 the patient developed jaundice and fatigue and was hospitalized on 30 Oct 2026 with drug-induced liver injury. Velnorab was withdrawn; at the time of the report liver values were improving and the event was considered recovering.

AcceptEditQuery reporterSign

Regulatory clock

Know every deadline before it knows you.

Expedita starts the clock at Day 0 — the first day the minimum criteria are known to your organization — and tracks every due date per authority and report type.

For example, 15 calendar days for serious unexpected postmarketing reports to FDA; 15 days for serious and 90 days for non-serious cases in the EU.

Your team sees what is due, where, and how many days remain, before it becomes a finding.

Case timeline

Sample — illustrative

Day 15 · due

13 days of buffer

Day 0Report received
Min 5Valid case created and triaged
Min 20Coded case and narrative ready for medical review
Day 2Signed and submitted

Clock

Synthetic data

Case ID	Authority	Report type	Due	Days left
EXP-2026-004812	FDA	15-day expedited	17 Nov 2026	4
EXP-2026-004790	EMA (EV)	Serious, 15-day	15 Nov 2026	2
EXP-2026-004805	MHRA	Serious, 15-day	24 Nov 2026	11
EXP-2026-004771	EMA (EV)	Non-serious, 90-day	29 Jan 2027	77

Literature

Literature screening that reads the whole paper.

Relevance triage

Every abstract from your weekly global and local searches is screened for relevance to your products, with the reason recorded.

ICSR identification

Reads the full text to find an identifiable patient, reporter, suspect product and adverse event — not just the abstract.

Duplicate check

Matches each potential ICSR against cases you already hold, so the same patient isn't reported twice.

Weekly run — Sample

Synthetic data

2,140

abstracts screened

flagged as relevant

potential ICSRs

possible duplicates

Compliance

Built to be inspected.

Source traceability

Every extracted field links to the exact sentence in the original source.

Full audit trail

Every proposal, edit and signature is recorded with who, what and when.

Electronic signatures

Designed for 21 CFR Part 11 and EU Annex 11 expectations.

Validation package

Requirements, test scripts and traceability matrix for your computerized-system validation.

Versioned models

Under change control — no silent updates.

Human sign-off

A qualified safety professional signs every medical judgment.

Deployment

Fits the safety system you already run.

No migration

Exports E2B(R3) XML to your existing safety database.

Your tenant or ours

Runs in your cloud tenant or in our EU or US region.

Privacy by design

Personal and health data processed under GDPR and HIPAA requirements, encrypted in transit and at rest.

Your data stays yours

Never used to train models for other customers.

NOTE

From 1 October 2026, FDA accepts postmarketing ICSRs only in E2B(R3) format. Expedita produces R3 natively.

Pilot

Prove it on your own cases first.

Weeks 1–2

Configure

Product dictionaries, reference safety information and your narrative conventions.

Weeks 3–6

Shadow mode

Expedita processes the same cases in parallel; every output is compared with your team's final case.

Weeks 7–8

Go live

For the case types that met your acceptance criteria.

FAQ

Questions safety teams ask.

No. It proposes seriousness, expectedness and causality with its reasoning and sources. Qualified safety professionals review, edit and sign every case.

Patients report. Your team responds, on time, every time.