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All-Inclusive Agile Customizable

SafetyEasy® Vigilance: Your Multivigilance Data Management Solution

Simplify vigilance management in one cloud platform—efficient, scalable, and audit-ready.

Start With What You Need
Avoid Overcommitting
Stay Agile
Ensure Affordability

How SafetyEasy® Vigilance Works

SafetyEasy® Vigilance unifies all vigilance domains in one platform—capturing cases, automating workflows, and ensuring regulatory compliance from intake to reporting.

Capture Cases
Import safety data from multiple sources.
Automate Workflows
Apply rules and automate coding seamlessly
Ensure Compliance
Generate reports aligned with global standards.
Gain Insights
Detect signals and track trends across domains.

Smarter Workflows, Automated Reporting, Global Compliance

Features and Advanced Capabilities

Data Management
Signal Detection
Regulatory Reporting
Automation
Advanced Capabilities
Data Management

Data Management

  • E2B R2/R3 import, export, and validation
  • Gateway integration
  • MedDRA & SMQs
  • IME list support
  • HL7 Gateway for medical devices
  • MedDRA recoding
Data Management
Signal Detection

Signal Detection

  • PRR, ROR, qualitative analysis
  • FDA combination product support
Signal Detection
Regulatory Reporting

Regulatory Reporting

  • PSUR, DSUR, PBRER, PADER
  • MDCG 2020-10/2, MDCG 2024-04
  • Ad-hoc queries
  • IME list support
  • Customized reports
Regulatory Reporting
Automation

Automation

  • Customized Workflows
  • Reportability Matrix
  • Automatic labeling & submission
  • Duplicate checks
  • Translation tools
  • Customized lists (lab tests, flags, codes)
  • Customized Anonymization
Automation
Advanced Capabilities

Advanced Capabilities

SafetyEasy is designed to streamline safety case management with intelligent automation and flexibility. Its advanced features empower teams to work faster and smarter, with global regulations.

AI-Powered Follow-Up Narrative Generation:

Detects differences between the initial case and new information to automatically suggest a clear, compliant narrative.

Dynamic Reportability Matrix:

Create rules to automatically route cases to your partners based on global reporting requirements.

Instance-Level Customization:

Provides customers full autonomy to customize fields, workflows, and templates—ensuring complete alignment with organizational processes and continuous improvement.

Scalable Multivigilance for Every Need

Customizable Safety Platform That Fits Your organization’s needs

Customize SafetyEasy® to your needs—choose vigilance domains and scale pricing effortlessly.

Supported Vigilance Types

Medicine-pil

Pharmacovigilance

monitor

Medical Device Vigilance

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Cosmetovigilance

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Nutrivigilance

Biotech-firms

Biovigilance

Other Clinical & Post-Market Studies

Line

End-to-End Coverage Across the Product Lifecycle

Clinical trials (Phase I–III)

Manage adverse events (AEs), serious adverse events (SAEs), and SUSARs with compliance

Post-authorization studies (Phase IV)

Monitor long-term safety and real-world data

Post-marketing surveillance

Track spontaneous reports, literature cases, and patients feedback

Other studies

Including observational, epidemiological, and investigator-initiated research

Why Multivigilance Matters

Healthcare products often cross multiple domains—drugs, devices, cosmetics, and nutrition. Managing them separately creates inefficiencies and compliance risks. SafetyEasy® Vigilance unifies them in one intelligent platform.

Centralized Safety Oversight

Centralized Safety Oversight

Manage all safety cases from one dashboard.

Cross-Vigilance Intelligence icon

Cross-Vigilance Intelligence

Detect trends and signals across domains.

Streamlined Workflows icon

Streamlined Workflows

Shared automation and templates cut time and effort.

Compliance Across Domains icon

Compliance Across Domains

Stay compliant with evolving global requirements.

Cost Efficiency & Scalability icon

Cost Efficiency & Scalability

One platform, one vendor, lower total costs.

Scalable Package Options

Select the package that aligns with your current operations and scale as you grow

Entry

Up to 20 cases/year

For small teams or early-stage companies

Light

21-50 cases/year

For growing organizations with moderate cases

Entry

51-200 cases/year

For mid-sized operations

Professional

201-1000 cases/year

Scalable for growing workloads

Intensive

>1000 cases/year

For high-volume case management

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Compliance & Security by Design - Built on a robust, pre-validated framework aligned with GAMP®5 and FDA CFR21 Part 11 standards.

Trusted by Industry Leaders

“SafetyEasy® has become an essential tool, enabling us to efficiently deliver PV services to our clients. As a CRO we are taking advantage of SafetyEasy®’s onboarding flexibility,seamless upgrades and effective AB Cube support.”

PSI

“Visually logical and intuitive infrastructure, with ease of use contributing to satisfaction from the PV team.”

Septodont

“SafetyEasy® Suite is a robust system that is always evolving to meet our needs. The automatic narrative templates help us to manage our PV cases much more efficiently. With AB Cube, we are saving time.”

Air Liquide

pharmalex
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groupe clarins
PLG
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