Pharmacovigilance full-features
Core Pharmacovigilance
| 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
| 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 |
Pricing
| Based purely on case load not number of users |
| Licence fee / maintenance option for local installations |