Product Comparison

This is a feature comparison between our Essentials, Premium and Enterprise products.

 
Essentials
Premium
Enterprise

Core pharmacovigilance

     
Electronic reporting to any regulatory authority
Process adverse events from clinical trials and marketed products in the same database
Include product defect case and medical enquiries
MedDRA / VeDDRA coding included
Create CIOMS, MedWatch 3500, FDA 1932, CVMP reports
Batch reporting  
Create PSUR, DSUR and summary tables
Basic signal detection reports
Data validation to EMA / FDA standards
       

Extended pharmacovigilance functions

     
Comprehensive data querying
Store external documents in case record
Workflow on demand  
Export reports to pdf
Export data to Excel
Gateway available for automated e-reporting option
Full process control workflow module   option option
       

Flexibility

     
Configurable vocabulary lists  
System fully configurable    
User – defined screen for data entry of additional data    
       

Quality

     
Regulatory compliant audit trail
Software tested before release to an ISO 9001:2008 standard
Pre-validated software  
Validation package available   option
Validation certificate and testing evidence provided
Validation and test templates available for local execution  
       

Support

     
New software versions provided
On-line training videos  
Dedicated user training Option Option
Email support
Telephone support Option
       

IT Environment

     
Secure data centre  
All data backed up  
Separate test system  
Dedicated database  
Oracle database technology
       

Costs

     
Pay annual option  
Licence fee / annual maintenance