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

Multivigilance

Harness the power of automation for your global regulatory requirements
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Align international vigilance operations teams with an intuitive, unified, cloud-based system trusted by industry leaders. SafetyEasy® Suite is a multivigilance management solution which integrates automation with existing drug safety processes of life sciences organisations to manage adverse event reporting and stay compliant with the latest regulations. 

Benefits

BOOST EFFICIENCY

  • Manage cases with combination products
  • Manage cases with products with different regulatory statuses depending of country
  • Improve collaboration among 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 regulations.

AI POWERED

AB Cube simplifies automation for your safety operations. SafetyEasy® Suite integrates seamlessly with your existing vigilance processes 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 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 multivigilance easy

Streamline safety operations on combination product reporting in different countries. Manage your PV and medical devices vigilance operations on a single application. Report biovigilance and pharmacovigilance adverse events on the same database for your FDA regulatory requirements.

Tackle the challenges of optimising operational efficiency while reporting sunscreen as a pharmaceutical product in FDA and a cosmetic product in EMA while processing safety cases. Tick one box to fulfil both requirements, pharmacovigilance as well as cosmetovigilance.

European & worldwide regulations compliance, FDA 21 CFR part 11 designed, SafetyEasy® Suite cloud-based multivigilance management solution conforms to FDA, EMA and MHRA requirements and is regularly upgraded to comply with latest regulations. Meeting combination product regulatory requirements was never easier. 

Testimonials

Discover other vigilances

Pharmacovigilance

Medical Device Vigilance