SafetyEasy® Suite has been deployed by ANSM for the surveillance of the French national vaccination program against SARS-CoV-2.

Reach out to us for your EMA-compliant vaccine safety database requirements.

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SafetyEasy® Suite

Pharmacovigilance

Efficient drug safety operations with the technological expertise of industry veterans begins here
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Align international pharmacovigilance operations teams with an intuitive, unified, cloud-based safety system trusted by industry leaders. SafetyEasy® Suite is a multivigilance management solution which integrates automation with existing drug safety processes.

Growing biotechnology firms trust individual vigilances provided by AB Cube for their safety regulatory processes. Life sciences organisations manage adverse event reporting and stay compliant with the latest regulations with SafetyEasy® Suite. 

Benefits

BOOST EFFICIENCY

  • Improve collaboration among PV teams in real-time with deadline & reminder management systems. 
  • Edit reports in the blink of an eye without waiting for the system to load. 
  • Get automatic system updates to stay current with the latest drug safety regulations.
  • Enhance operational efficiency with a faster and agile safety solution.

AI POWERED

AB Cube simplifies automation for your safety operations. SafetyEasy® Suite integrates seamlessly with your existing pharmacovigilance system with minimal training. Leverage the power of automation with our 3-step process.

  1. Basic automation
  2. Robotic process automation
  3. Cognitive automation

Get ready to step into the world of pharmacovigilance powered by artificial intelligence.

POWERFUL REPORTING

Spontaneously generate submission ready drug safety regulatory reports automatically populated with entered data.

  • CIOMS & MedWatch
  • Periodic Safety Update Report (PSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Development Safety Update Report (DSUR)
  • Signal detection, line listings & summary tabulations

Increased ROI on multivigilance operations with

  • INTUITIVE USER INTERFACE

    Automatically populated fields, narrative generation in just one click, smart MedDRA coding, integrated query module, fully customisable workflow
  • SECURE & COMPLIANT SaaS

    HDS compliant server hosting for sensitive healthcare information, 2 hours Disaster Recovery Plan (DRP), HIPAA compliant, SSL web access, 99.99% SLA guaranteed, 21 CFR part 11 Audit Trail, ISO 27001 data center (Tiers III plus)
  • ONE-CLICK SUBMISSION

    Smart E2B XML creator (R2, R3), multiple formats supported (MedWatch, CIOMS, Meddev, etc.) and email submission
  • 2 WEEK IMPLEMENTATION

    Digitise your excel-based and paper-trail regulatory reporting with SafetyEasy® Suite in less than 2 weeks
  • NO HIDDEN COSTS

    Transparent terms and conditions since Day 1. Unlimited number of users, quarterly upgrades and support included in your licence. Your support tickets would not circle the world, our support team based in France is promptly resolves bugs and queries.
  • FULLY VALIDATED

    GAMP 5 validation, online validation dossier available, validation dossier updated with each upgrade. Minimum validation effort required from the users.

Our customers

We’re making drug safety easy

Streamline drug safety operations with a system dedicated to the management of Adverse Events related to pharmaceutical products. SafetyEasy® Suite, cloud-based pharmacovigilance (human) system is fully E2B (R3) compliant.

Linked to iTAP® Triage, our very own triage environment, SafetyEasy® Suite enables efficient signal detection and faster generation of regulatory reports. Automatic recoding with new MedDRA versions and SMQs in the safety database, this database is equipped with a completely customisable workflow to adapt to your organisation.

Integrated Business Intelligence tool in the pharmacovigilance safety software allows you to oversee and improve user productivity. One-click submission through our gateway is available to exchange with EMA and FDA. SafetyEasy® Suite can be used with Web Traders too.

Testimonials

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