SAFETYEASY® SUITE

Multivigilance

Harness the power of automation for your global regulatory requirements.

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

COST EFFECTIVE
0%
  • 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.
SUBMISSION READINESS
0%

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

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.

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

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

Increased ROI on multivigilance operations with

SECURE AND 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 COST

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.

INTUITIVE USER INTERFACE

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

FULLY VALIDATED

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

« More than just a software vendor, AB Cube has been an important partner in our regulatory compliance. SafetyEasy® Suite is a secure, reliable, and user-friendly software which allows us to be compliant with safety requirements »

Global Head, Pharmacovigilance - EU QPPV -

Global Head, Pharmacovigilance - EU QPPV -

Air Liquide Santé International

« We especially appreciate the user-friendly interface and customisation capability, the ability of SafetyEasy® to evolve and adapt to the latest guidelines, the support offered by AB Cube and the responsiveness of their team »

EU QPPV & API Director

EU QPPV & API Director

Laboratoires SMB SA

ALWAYS COMPLIANT

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. 

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

DATA ENTRY

User-friendly data entry | Inbuilt MedDRA coder | Duplicate check management | Generate narrative templates | Follow-up management | Attach documents | E2B (R3) data entry | E2B (R3) data entry import/export | E2B (R2/R3) validation | E2B (R2) import/export

ADMINISTRATION

ADMINISTRATION

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

TOOLS

TOOLS

  • MedDRA SMQ
  • Integrated query module
  • Calendar (submission & follow-up management)
  • Automatic mail generation
  • Schedule and assign tasks

INTEGRATION

INTEGRATION

  • AB Cube’s own Gateway or Web Trader integration
  • Link with SafetyEasy® MI
  • WHO Drug Dictionary (WHODD) integration
  • XEVMPD/IDMP integration
  • EudraCT link

REPORT GENERATION

REPORT GENERATION

  • CIOMS I, MedWatch, …
  • XML E2B (R2) and E2B (R3) HL7 Import/Export
  • Line-Listing (PSUR, PBRER, DSUR, …)
  • Summary tabulation (PSUR, PBRER, DSUR, …)
  • Signal detection: PPR, Qualitative

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Dicover other vigilances

Pharmacovigilance

Efficient drug safety operations with the expertise of industry veterans begins here

Pharmacovigilance

Global compliance | User-friendly interface | Secure HDS compliant servers

MedDevice Vigilance

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

MedDevice Vigilance

Flexible, intelligent system responds to your organisational needs | FDA & EMA reporting at once

Cosmetovigilance

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

Cosmetovigilance

Trusted by world leaders in cosmetics | Compliant with international regulations | Customisable workflows

Nutrivigilance

Ensure productive nutrient safety reporting with a native nutrivigilance solution

Nutrivigilance

Instinctive schema for smoother operations | Nutrient & protein regulatory adverse events reporting