License cost per user

Description

The “Enterprise” option offers a complete pharmacovigilance solution in an easy-to-use system for installation in your computing environment.

Its key benefits are:

    • Process clinical trial and spontaneous adverse events
    • Support for product defects and enquiries
    • Electronic reporting to any regulatory authority in the required format
    • Create common regulatory reports such as CIOMS, MedWatch / 3500, 1932, CVMP, PSUR and DSUR
    • Batch reporting
    • MedDRA / VeDDRA coding built in – and updated automatically with every release
    • Basic signal detection reports included
    • Configured to use EMA / FDA vocabulary lists
      All case data validated for completeness against EMA / FDA e-reporting rules

    • Comprehensive querying
    • Data export to pdf and Excel
    • Store external documents as part of the case record
    • Ad hoc / on demand workflow tasks
    • Option for full process driven workflow
    • User defined screen to capture additional data

 

  • Ability to add Crystal Reports designed by customer
  • Divide cases into restricted access groups eg for client access
  • Regulatory compliant audit trail
  • Any number of users – Licence priced “per user”
  • Unlimited number of cases can be entered
  • Email support available
  • Telephone support
  • Software maintained in line with regulations
  • All new versions of PV-Works included in cost of annual maintenance and support
  • Manage access and security in compliance with your company’s policies
  • Install as many test and training environments as necessary for a single licence cost
  • Also available with Enterprise option:
  • Enterprise solutions are based on Assured’s PV-Works software suite
  • Fully configurable system – vocabularies, pre-defined queries, access permissions, validation rules etc

Please contact our sales team for a detailed quote.

Pricing

Please contact us for a quote that will take into account all your specific requirements. Enterprise pricing is per user.

Next steps

With the “Enterprise” PV247 package from Ennov you might expect to be up and running within 1-3 months depending upon the extent of local configuration, training, business integration and validation required:

  • Create your free account now to evaluate the core features of the software
  • Contact Assured to discuss your requirements now
  • Agree contract terms
  • Install local system, and undertake Enterprise system configuration (with or without Ennov PV consultancy support)
  • A validation package is supplied by Assured, but you may need to undertake additional steps to comply with your internal company policies
  • Receive full user training
  • Start using PV-Works in production within 1-3 months

Once you have sent us your contact request, our sales team will quickly contact you.

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