Annual or monthly payment plans - first month free

Description

“Premium” provides comprehensive pharmacovigilance capability in an easy-to-use system for customers with over 100 cases per year and offers more functionality and flexibility than “Essentials”.

The “Premium” system also entitles you to a separate test system free of charge.

The Premium 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
  • Premium costs fit companies with 100 to an unlimited number of cases per year
  • Also available with Premium option:

 

Pricing

  • Costs in $ USD

    Premium package

    P-1

    P-2

    P-3

    Included cases per year – up to
    250
    500
    1,000*
    Cost per year $24,000 $36,000 $52,000
    Additional cases above package limit… per case $68 $38 $22

    Options

         
    Dedicated server $10,000 $10,000 $10,000
    Process driven workflow – per year † $6,000 $6,000 $6,000
    One day dedicated user training via the internet $1,200 $1,200 $1,200
    One-half day dedicated administrator training via the internet $600 $600 $600
    One and a half days training in your offices $2,400 $2,400 $2,400

    * above this volume, please contact us for a personal quotation
    † consultancy also available for process design

     

    Sample Price Plans

    Cases per year

    Recommended package

    Total cost

    Average cost per case

    100 P-1 $24,000 $240
    200 P-1 $24,000 $120
    250 P-1 $24,000 $96
    300 P-1 with additional case fees $27,400 $91.33
    400 P-1 with additional case fees $34,200 $85.50
    500 P-2 $36,000 $72
    600 with additional case fees P-2 with additional case fees $39,800 $66.33
    750 P-2 with additional case fees $45,500 $60.67
    1000 P-3 $52,000 $52
    1250 P-3 with additional case fees $57,500 $46
    1500 P-3 with additional case fees $63,000 $42
    1750 P-3 with additional case fees $68,500 $39.14
    2000 Contact us
  • Costs in € EUR

    Premium package

    P-1

    P-2

    P-3

    Included cases per year – up to
    250
    500
    1 000*
    Cost per year €20 000 €30 000 €45 000
    Additional cases above package limit… per case €60 €30 €20

    Options

         
    Dedicated server €10 000 €10 000 €10 000
    Process driven workflow – per year † €6 000 €6 000 €6 000
    One day dedicated user training via the internet €1 050 €1 050 €1 050
    One-half day dedicated administrator training via the internet €600 €600 €600
    One and a half days training in your offices €2 200 €2 200 €2 200

    * above this volume, please contact us for a personal quotation
    † consultancy also available for process design

     

    Sample Price Plans

    Cases per year

    Recommended package

    Total cost

    Average cost per case

    100 P-1 €20 000 €200
    200 P-1 €20 000 €100
    250 P-1 €20 000 €80
    300 P-1 with additional case fees €23 000 €76,67
    400 P-1 with additional case fees €29 000 €72,50
    500 P-2 €30 000 €60
    600 P-2 with additional case fees €33 000 €55
    750 P-2 with additional case fees €37 500 €50
    1000 P-3 €45 000 €45
    1250 P-3 with additional case fees €50 000 €40
    1500 P-3 with additional case fees €55 000 €36,67
    1750 P-3 with additional case fees €60 000 €34,29
    2000 Contact us

You will pay annually for your “Premium” package:

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

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

Next steps

With the “Premium” PV247 package from Ennov you can be up and running in just a few hours:

  • Create your free account now
  • You will receive a confirmation email with instructions on how to launch your new PV-Works 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 Premium system immediately for either test or production cases. Premium 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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