New Era, New Solutions – AI-Powered Adverse Event Database

Blazing Fast. AI-Powered. Cost-Efficient. If you're tired of outdated, slow, and clunky interfaces, it's time to switch to a smarter, faster, and more efficient pharmacovigilance solution.

Revolutionizing Adverse Event Management with AI

Our platform brings the next generation of pharmacovigilance, automating adverse event collection, structuring data, and ensuring seamless regulatory compliance with ICH E2B(R2) and E2B(R3) standards.

Lightning-Fast

Centralized, structured, and instantly accessible – ensuring seamless regulatory submissions with zero delays.

Multi-Format Support (E2B R2 & R3)

Effortlessly generate and submit reports in both E2B(R2) and E2B(R3) formats, meeting the latest compliance requirements worldwide.

Incredible AI for Smarter Risk Management

AI-powered signal detection and risk assessment reduce manual effort, highlight safety trends, and ensure proactive decision-making.

Data Integrity

Compliance with FDA CFR 21 Part 11
for electronic records and signatures. Certificate of conformity allows you to use officially the system in EU, US, CIS markets.

Information security

Data centers with a certified information security management system according to ISO / IEC 27001:2013 and DigitalOcean SOC 2 Type II.

Always-On Access

Log in anytime, anywhere. AI keeps your literature monitoring fully automated – no manual searches, no downloads, just instant insights.

How it works?

Switch Instantly

AI captures, structures, and processes adverse event reports from multiple sources in seconds.

AI-Powered

Identify duplicate cases, assess severity, and detect emerging safety trends in real-time.

Automated E2B Submission

Convert reports into E2B(R2) or E2B(R3) formats instantly and submit them to regulatory authorities without hassle.

Full compliance with GVP
The system contains built-in support for the necessary functions to ensure GxP activity and good documentation practice:
No more outdated workflows - AI takes care of everything, so you can focus on critical safety insights.
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