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

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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.

Features and Advanced Capabilities

Data Management

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

Signal Detection

• PRR, ROR, qualitative analysis
• FDA combination product support

Regulatory Reporting

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

Automation

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

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

Pharmacovigilance
Medical Device Vigilance
Cosmetovigilance
Nutrivigilance
Biovigilance

Other Clinical & Post-Market Studies

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

Manage all safety cases from one dashboard.

Cross-Vigilance Intelligence

Detect trends and signals across domains.

Streamlined Workflows

Shared automation and templates cut time and effort.

Compliance Across Domains

Stay compliant with evolving global requirements.

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

Compliance & Security by Design

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