SAFETYEASY® SUITE
Medical Device Vigilance
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.
Features
Gain efficiencies with industry’s trusted medical device 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, High Availability Infrastructure, Disaster Recovery Plan: Immediate fail over to distant server in case of disaster, 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
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 Vigilance easy
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.
NEWSLETTER
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FEATURES
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