AE Connect is a guided adverse event intake form with built-in AI triage that connects directly to Veeva Vault Safety, Oracle Argus, and other ICSR systems. No more rekeying. No more data gaps between intake and your safety database.
AE Connect solves the two biggest pain points in adverse event processing: getting complete, structured data in the door, and getting it into your safety database without manual transcription.
A guided, 5-step web form that walks reporters through a complete adverse event submission, ensuring every case arrives with the data your PV team needs.
AE Connect pushes structured, AI-triaged cases directly into the safety databases you already use, no manual rekeying, no copy-paste, no data gaps.
Most adverse event reporting starts with an email, a voicemail, or a PDF fax. The PV team spends hours chasing missing information and manually transcribing data into their safety database. AE Connect replaces that chaos with a structured, guided intake form that captures complete cases from the start.
Healthcare professionals get a streamlined version with medical terminology. Patients see a simplified form with plain language. Field sales reps use a mobile-optimized format for on-the-go reporting. Each variant captures the same structured data.
Each organization gets its own branded intake URL with custom product lists, field requirements, consent language, and welcome/thank-you messages. Admin teams configure everything through a visual form builder, no code required.
The second a report is submitted, AE Connect's AI engine reads the narrative, codes MedDRA terms, assesses seriousness and causality, and flags expedited cases. By the time your PV specialist opens the case, the AI analysis is already waiting.
Demographics, age, weight, medical history, concomitant medications. Structured fields with smart defaults and validation.
Suspect product from org-configured list, dosage, route, frequency, therapy dates. Supports multiple products per report.
Free-text narrative of the adverse event, onset date, seriousness criteria, outcome, treatment. Rich text with file attachments.
Name, credentials (HCP, patient, consumer), institution, contact info, consent to follow-up. Optional anonymous reporting.
Full summary of all entered data. Edit any section before final submission. E-signature capture. Confirmation with reference ID.
AE Connect isn't a replacement for Veeva or Argus. It's the intelligent intake layer that sits in front of them, capturing structured data, enriching it with AI, and pushing approved cases directly into your existing system.
Structured capture → AI triage → PV review
Direct API integration. Cases arrive in your Vault Safety inbox as structured ICSRs with MedDRA coding, causality, and all mapped fields intact.
INTEGRATION READYSubmit triaged cases via E2B(R3) XML or direct API. Field mappings, coded terms, and assessments transfer automatically to Argus.
INTEGRATION READYGenerate ICH-compliant E2B(R3) XML for any safety database or direct submission to FDA MedWatch and EudraVigilance.
BETADocumented REST endpoints for custom integrations. Pull structured case data into ArisGlobal or any proprietary system.
COMING SOONMost biotechs choose between expensive enterprise PV suites or cobbling together emails and spreadsheets. AE Connect gives you the intake and integration layer without replacing your safety database.
| Capability | AE Connect | Enterprise PV Suite | Email + Spreadsheets |
|---|---|---|---|
| Guided reporter intake form | ✓ 5-step guided flow | Varies, often complex | ✗ Unstructured |
| AI-powered MedDRA coding | ✓ Instant on submission | Add-on, extra cost | ✗ Manual only |
| Safety database integration | ✓ Veeva, Argus, E2B, API | ✓ Built-in (is the DB) | ✗ Manual rekeying |
| Time to implement | ✓ Days | ~ 6–18 months | ✓ Immediate |
| Works with existing safety DB | ✓ Designed for it | ✗ Replaces it | ~ Manual bridge |
| Multi-channel capture | ✓ Web, mobile, email | ✓ Varies by vendor | ✗ Ad hoc |
| Configurable per organization | ✓ Visual form builder | ~ Requires IT/vendor | ✗ No structure |
Flat annual subscription. No per-case fees. No surprises. Start with the tier that fits your PV operation today and upgrade as you grow.
First commercial product. Lean PV team. Building from the ground up.
1–2 commercial products. Active PV function. Replacing manual CRO processing.
2–4 products. Established PV team. Modernizing legacy infrastructure.
4+ products. Custom volume. Full-service PV platform deployment.
Join the private beta and see how AE Connect eliminates the gap between adverse event intake and your safety database.