Adverse event follow-ups in hours, not weeks.
Aušra reaches patients wherever they are — SMS — asks the fewest questions science allows, and hands your team a submission-ready CIOMS I form. Automatically.
Follow-ups are where good
case data goes to die.
Most adverse event reports arrive incomplete. Chasing the missing pieces takes phone tag, fax machines, and weeks of analyst time — while regulatory clocks keep ticking.
of initial AE reports are incomplete
Missing dechallenge data, unclear onset dates, unknown concomitant meds — every gap is a query, and every query is a delay.
typical follow-up cycle time
Letters, voicemails, and missed calls stretch a 10-minute conversation into more than a month of dead air.
is all Aušra needs
From first outreach to a structured, MedDRA-coded, submission-ready case. While your analysts sleep.
Three moves. Zero chasing.
Reach patients where they already are
Aušra orchestrates outreach across SMS, WhatsApp, voice, email, and secure web — automatically picking the channel each patient actually answers, in their language and time zone. No answer on one channel? It gracefully escalates to the next.
- Smart channel & send-time selection per patient
- 40+ languages with validated medical translation
- Consent-first, opt-out aware on every touchpoint
Ask less. Learn more.
Our proprietary adaptive question engine reads what's already in the case, infers what it can, and asks only what it must. Patients answer a handful of plain-language questions — Aušra converts them into dozens of structured regulatory data points.
- Question count minimized case-by-case, in real time
- Plain language in, MedDRA-coded data out
- Seriousness criteria flagged the moment they appear
Watch the CIOMS I form fill itself
Every answer flows straight into the regulatory form — CIOMS I, MedWatch 3500A, or E2B(R3) XML. Your analyst reviews a finished case instead of building one. One click to route for signature and submission.
- Field-level provenance: every value traces to its source
- Auto-drafted case narrative, ready for medical review
- Export to E2B(R3) for EudraVigilance & FAERS gateways
One queue. Every case.
Always inspection-ready.
Your safety team gets a single command center: live follow-up status, due-date countdowns, and cases sorted by what actually needs a human.
Everything between
“patient said” and “agency received.”
Omnichannel orchestration
SMS, WhatsApp, voice AI, email, and secure web portal — sequenced intelligently with retries, escalations, and quiet hours.
Adaptive question engine
Proprietary inference minimizes patient burden: ask 3 questions, capture 20+ structured fields, never ask what's already known.
Regulatory form autofill
CIOMS I, MedWatch 3500A, and E2B(R3) populated with field-level provenance and an auto-drafted narrative.
MedDRA auto-coding
Verbatim terms mapped to MedDRA PT/LLT with confidence scores — your coders approve, not transcribe.
Human-in-the-loop review
Serious cases and low-confidence answers route instantly to your medical reviewers. AI does the legwork; humans make the calls.
Audit-grade by design
21 CFR Part 11 e-signatures, immutable audit trails, HIPAA & GDPR controls, and full data residency options.
Validated like a medical device,
not a chatbot.
Every prompt, inference, and mapping in Aušra ships with documented validation. Our models are evaluated against gold-standard case sets, monitored for drift, and constrained so that nothing reaches a regulator without a qualified human signature.
“ Our analysts used to spend their week leaving voicemails. Now they spend it doing actual safety science. Follow-up cycle time went from 26 days to under 12 hours.
The dawn of effortless
pharmacovigilance.
See your own follow-up workflow running on Aušra — live, with your forms — in a 30-minute demo.
No spreadsheets were harmed in the making of this platform.