AE Connect

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AE Connect is an AI-powered adverse event intake and ICSR preparation platform purpose-built for small and mid-size biotech companies. It replaces paper forms and email-based intake with a structured, validated electronic workflow that captures E2B(R3) compliant data from first contact. Features include a 5-step guided intake form, AI-assisted MedDRA coding, automated seriousness classification, ICSR narrative generation, and role-based case management. Built for 21 CFR Part 11 and ICH E2B(R3) compliance.