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SAFETYEASY® SUITE

Medical Device Vigilance

Keep up with the changing regulations while optimising operational efficiency and user productivity.

Align international medical device 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 safety processes of life sciences organisations to manage adverse event reporting and stay compliant with the latest regulations.

Growing medical device manufacturers and resellers trust individual vigilances provided by AB Cube for their safety regulatory processes.

Vigilance-Infograph

Features

Gain efficiencies with industry’s trusted cosmetics safety solution fully dedicated to the management of Adverse Events, always aligned with the best practice and modern regulations.

Data entry

  • User-friendly data entry
  • Inbuilt MedDRA coder, IMDRF coder
  • Duplicate check management
  • Generate narrative templates
  • Follow-up management
  • Attach documents

Tools

  • MedDRA SMQ
  • Integrated query module
  • Duplicate check management
  • Automatic mail generation
  • Schedule and assign tasks

Report generation

  • SAE Report table (MEDDEV 2.7/3), MedWatch, MIR…
  • Coming soon : Clinical Investigation Summary Safety Report Form (MDCG 2020 10-2)
  • eMDR XML HL7 Export
  • ANSM Form 5, Form 6,
  • DSUR tabulation & Line Listing

Administration

  • Full workflow management
  • Users administration
  • User’s group rights management

Integration

  • Integrate with pharmacovigilance, cosmetovigilance or biovigilance for combination product reporting within SafetyEasy® Suite, multivigilance management solution

Data entry

  • User-friendly data entry
  • Inbuilt MedDRA coder, IMDRF coder
  • Duplicate check management
  • Generate narrative templates
  • Follow-up management
  • Attach documents

Administration

  • Full workflow management
  • Users administration
  • User’s group rights management

Tools

  • MedDRA SMQ
  • Integrated query module
  • Duplicate check management
  • Automatic mail generation
  • Schedule and assign tasks

Integration

  • Integrate with pharmacovigilance, cosmetovigilance or biovigilance for combination product reporting within SafetyEasy® Suite, multivigilance management solution

Report generation

  • SAE Report table (MEDDEV 2.7/3), MedWatch, MIR…
  • Coming soon : Clinical Investigation Summary Safety Report Form (MDCG 2020 10-2)
  • eMDR XML HL7 Export
  • ANSM Form 5, Form 6,
  • DSUR tabulation & Line Listing

WE’RE READY

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.

BASIC AUTOMATION

ROBOTIC PROCESS AUTOMATION

COGNITIVE AUTOMATION

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

Increased ROI on multivigilance operations

Industry’s first cloud-based pharmacovigilance software, SafetyEasy® was launched in 2006 when on-premise software was the norm. We accompany academic research centres, CROs and MAHs as their trusted safety software with our reliable technology.

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

Intuitive user interface

Automatically populated fields, narrative generation in just one click, smart MedDRA coding, integrated query module, fully customisable workflow

No hidden cost

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

2 week implementation

Digitise your excel-based and paper-trail regulatory reporting with SafetyEasy® Suite in less than 2 weeks

Fully validated

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

One-click submission

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

No hidden cost

Transparent terms and conditions since Day 1. Unlimited number of users, quarterly upgrades and support included in your license. 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

TESTIMONIALS

What our clients say

Boost Efficiency

  • Improve collaboration among PV teams in real-time with deadline and 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.
  • Enhance operational efficiency with a faster and agile safety solution.

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

ALWAYS COMPLIANT

We’re making medical device safety easy

Streamline safety operations with a system dedicated to the management of Adverse Events related to medical devices. SafetyEasy® Suite, cloud-based medical device vigilance is fully HL7 compliant and supports eMDR XML file creation.

Automatic recoding with new MedDRA versions enables easy data analysis. This system is equipped with completely customisable workflows to adapt to your organisation.

Integrated Business Intelligence tool in the medical device vigilance solution allows you to oversee and improve user productivity.

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FEATURES

Discover other vigilances

AB Cube fulfils vigilance requirements of every scale and scope, from prominent pharmaceuticals to emerging biotechnology firms. We provide drug safety and multivigilance solutions tailored to your needs.

Multivigilance

Harness the power of easy automation for all your global regulatory requirements

Pharmacovigilance

Keep up with the changing regulations while optimising operation efficiency & productivity

Cosmetovigilance

Benefit from the world’s first and only native cosmetics adverse events reporting system

Nutrivigilance

Ensure productive nutrient safety reporting with a native nutrivigilance solution