Comparison of offers

Essential Premium Enterprise
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Core pharmacovigilance

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

Extended pharmacovigilance functions

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

Flexibility

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

Quality

Regulatory compliant audit trail X X X
Software tested before release to an ISO 9001:2015 standard X X X
Pre-validated software X X
Validation package available X option
Validation certificate and testing evidence provided X X X
Validation and test templates available for local execution X X

Support

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

IT Environment

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

Costs

Pay annual option X X
Licence fee / annual maintenance X
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