Replace paper forms and email chains with an enterprise-grade electronic intake system. Capture, triage, and generate E2B(R3) reports, in a fraction of the time.
Reporters submit AEs via PDF, fax, or email. Data is re-keyed manually, introducing errors and delays into every single case.
Each serious case takes days of manual triage, coding, narrative writing, and regulatory formatting before it can be submitted.
The FDA mandate is here. Legacy systems can't generate compliant XML. Small biotechs face $500K+ enterprise safety database costs.
Give reporters a secure, guided electronic form that captures structured data from the start, no more deciphering handwritten forms or parsing email attachments.
Configure intake fields, add product lists, set required fields, and apply your organization's branding, all from an admin panel. No development needed.
Generate ICH E2B(R3) compliant XML from structured case data instantly. No manual mapping. No format errors. Ready for FDA, EMA, and global submissions.
AI handles the heavy lifting, seriousness assessment, MedDRA coding, causality analysis, and priority assignment, so your team focuses on decisions, not data entry.
AE Connect is architected from the ground up for pharmaceutical compliance, with encryption, audit trails, and access controls at every layer.
Start with a free pilot. No credit card. No commitment. See how AE Connect transforms your PV workflow in days, not months.