Pharmacovigilance full-features

Core Pharmacovigilance PV-Works Human PV-Works Vet

Human pharmacovigilance solution (including ICH E2B)
Veterinary pharmacovigilance solution
Process spontaneous and clinical trial adverse event cases
Process product defects and technical enquiries
Follow a quality process with case approval
Apply standardized assessments
MedDRA / VeDDRA coding included
Generate compliant validated electronic reports to US and European agencies
Generate all common paper report formats including CIOMS, MedWatch, FDA, CVMP
Generate all common aggregate reports, including PSUR, DSUR and summary tabulations
Generate reports in batch mode
Built-in Gateway for electronic submission

Extended pharmacovigilance functions

Comprehensive data querying and powerful analysis
Fully flexible workflow module for process management
On-demand Workflow to support efficient case handling
Export data direct to Excel
Management reports built-in
Document management function

Signal detection and analysis PV-Analyzer

Calculate key statistical measures such as PRR, ROR, and MGPS
Apply intelligent stratification
Detect where customizable thresholds have been exceeded
Extensive mining and reporting capability
Prepare detailed analyses and graphical outputs
Integrate with external data sources to increase flexibility and depth

Data collection

Expand data collection with flexible capture technology
Promote maximal efficiency and accuracy
Support approved vocabularies and local language data collection
Compatible with a wide range of technology – PC / tablet / smartphone

Flexibility

Unlimited user access with hosted PV solution
Dictionary configuration function
Configurable vocabulary lists
Simple user-friendly interface
Fully configurable local installations also available

Quality

Developed according to an ISO 9001:2015 Quality Management System
Designed to comply with 21 CFR Part 11
Pre-validated software and installation routine
Additional material provided for advanced system validation
Regulatory compliant audit trail
Delivered from secure, state-of-the-art data center
Dedicated server option available
Stable, proven technology and design
Reliable Oracle platform

Support

Software version upgrades included at no extra cost
MedDRA / VeDDRA dictionary updates included at no extra cost
System environment monitored 24/7
Regular routine backups managed as part of the standard hosting package
System resilience and disaster recovery servers maintained
On-line training videos
Dedicated training courses available
Telephone / email support
Reliable Oracle platform
Based purely on case load not number of users
Licence fee / maintenance option for local installations
Pay-as-you-go option

 

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