Description

PV247 is a secure cloud-based pharmacovigilance database and case management solution.

All functionality is integrated in a simple intuitive manner, saving you time, money, and resources. PV247 is a process driven system. A purpose-built workflow engine is integrated with comprehensive safety functionality to provide management control of pharmacovigilance processes.

Updates are performed regularly by Ennov, to improve the software and more importantly to follow the evolution of regulatory standards and norms.

PV247 supports EMA / FDA vocabulary lists, regulatory reports such as CIOMS, MedWatch / 3500, 1932, CVMP, PSUR and DSUR, as well as MedDRA / VeDDRA coding…

The key benefits and features 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
  • Gateway available for submission of electronic reports
  • 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 custom workflow process
  • Configurable vocabulary lists
  • Pre-validated software

 

  • Regulatory compliant audit trail
  • Any number of users
  • Unlimited number of cases can be entered
  • On-line support and training videos
  • Email support available
  • Telephone support
  • Secure Category Tier III data centre
  • Routine data backups
  • Robust disaster recovery procedure
  • 24/7 access from any internet connected windows PC
  • Software maintained with regulations – with no additional cost for new versions
  • Separate test system
  • Option for a dedicated server
  • Also available :
    • Form based data collection via PV-Express
    • Advanced signal detection and data mining via PV-Analyzer
    • Can be integrated with EDC, QMS, CRMs and other systems

 

Pricing

  • Costs in $ USD

    Package

    P-0

    P-1

    P-2

    P-3

    P-4

    P-5

    P-6

    Included cases per year – up to
    100
    250
    500
    1,000
    2,500
    5,000
    10,000+
    Cost per year $12,000 $24,000 $36,000 $54,000 $105,000 $170,000 $280,000
    Additional cases above package limit… per case $120 $96 $72 $54 $42 $34 $28
  • Costs in € EUR

    Package

    P-0

    P-1

    P-2

    P-3

    P-4

    P-5

    P-6

    Included cases per year – up to
    100
    250
    500
    1,000
    2,500
    5,000
    10,000+
    Cost per year €10,000 €20,000 €30,000 €45,000 €88,000 €140,000 €235,000
    Additional cases above package limit… per case €100 €80 €60 €45 €35 €28 €24

Costs for additional cases above the package maximum will be invoiced monthly in arrears.

You may pay in US Dollars ($) or Euros (€).

Next steps

You can be up and running in just a few hours:

  • Contact us
  • Create your free account now
  • You will receive a confirmation email with instructions on how to launch your new Ennov PV software
  • Then you will need to:
    • add your company products
    • add additional user accounts if required
    • start entering and reporting cases!
  • You can use your system immediately for either test or production cases. Offer includes a free test database for all of your test cases before you start production.
  • Remember your first month’s use is free, without obligation
  • After this time if you wish to continue using the system you will need to pay the annual fee
  • The PV247 software package is pre-validated. However, please refer to our validation section for further information on integrating this solution into your own validated system

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