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Pharmacovigilance, automated — human in the loop

We turn patient signals into submission-ready safety reports.

Book a demo →See how it works
73%
fewer follow-up questions per case
9×
faster case-to-submission cycle
100%
cases reviewed by a qualified person
CIOMS I · 3500A
forms auto-populated & audited

Drug safety still runs on inboxes, spreadsheets and overnight backlogs.

Every adverse event a patient reports starts a regulated clock. Miss a follow-up, mis-code a reaction, or file a form late, and the cost lands as fines, warning letters and lost trust.

Aušra sits across the whole pathway — from the first patient signal to the submitted report. It asks only the questions that matter, fills the forms a regulator expects, and leaves a clean trail for a qualified person to sign off.

See the workflow →

How it works

[ 04 stages ]
01 — Intake & follow-up

The fewest questions, across any channel.

WhatsApp · SMS · Email · VoiceAdaptive engine

Our engine reads the drug, the patient history and what's already known, then generates only the gaps it needs to fill — so patients answer less and complete more.

02 — Auto-population

Answers become a CIOMS I in real time.

CIOMS IMedWatch 3500AMedDRA coded

Every confirmed answer maps to a regulated field. Watch the form fill itself, field by field, each one traceable back to the exact patient response.

03 — Assessment

Causality, severity and coding — proposed, not decided.

WHO-UMCSeriousness criteriaDuplicate check

Aušra drafts a causality assessment with its reasoning and confidence shown in full. The platform never files on its own — it hands a qualified person a complete, defensible draft.

04 — Human review & submit

A qualified person signs off. Always.

Immutable audit trailE2B(R3) export

Reviewers see every field, every source and every action the platform took. Approve, edit or reject — each decision is timestamped, attributed and locked into the record.

Curious what this does to your case backlog? Let's talk.

Most teams see their first auto-populated CIOMS I within a two-week pilot.
Built for the regulated world

Every standard your QPPV already answers to.

ICH E2B(R3)
ICSR electronic exchange
Native export
ICH E2D
Post-approval safety data
Workflow aligned
FDA 21 CFR 11
Electronic records & signatures
Compliant audit trail
GVP Module VI
Collection & reporting of ICSRs
EU aligned
MedDRA
Reaction & event coding
Latest version
CIOMS I
Suspect adverse reaction report
Auto-populated
FDA 3500A
MedWatch mandatory reporting
Auto-populated
ISO 27001
Information security
Data residency options
HIPAA · GDPR
Patient data protection
PII minimised
SOC 2 Type II
Security & availability
In progress
Our story

Aušra is the Lithuanian word for dawn.

We named it that because pharmacovigilance has spent decades in the dark — drowning in manual intake, late-night form-filling and the constant fear of a missed report. The people doing this work are some of the most careful in medicine, and they deserve better tools.

So we built a platform that does the repetitive, error-prone parts — the chasing, the coding, the typing — and hands the judgement back to the humans who are accountable for it. Faster cases, fewer fines, and a qualified person still in control of every decision.

Work with us →
AUŠRA · noun · /ˈauʃra/
1. daybreak; the first light after a long night.

2. the moment a safety team stops reacting and starts seeing every signal clearly.
15+
regulated fields populated per case, automatically
<5
questions average to complete a follow-up
24/7
intake across every patient channel
0
reports filed without human sign-off
Let's talk

Bring the dawn to your safety team.

Book a 30-minute walkthrough. Bring a real (de-identified) case and we'll run it through intake, follow-up and a populated CIOMS I — live.

or email hello@ausra.in
// No data leaves your environment during a pilot.