Premium

  • Product description

  • Pricing

  • Payment terms

  • Roadmap

Waith our PV-Works Training Videos

“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 utilises a dedicated company data environment and is supplied with a test system free of charge.

Open an account today and start processing cases within an hour.

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 process driven workflow
  • Configurable vocabulary lists

  • Pre-validated software
  • Validation package for internal use included
  • 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
  • All data backed up to different locations and off-site tape
  • 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:
  • Premium is implemented as a pre-configured version of Assured’s PV-Works software

Select your currency

Costs in $ USD

Premium package

P-1

P-2

P-3

Included cases per year – up to
250
500
1000*
Cost per year $23000 $36000 $52000
Additional cases above package limit… per case $68 $38 $22

Options

     
Dedicated server $10000 $10000 $10000
Process driven workflow – per year † $6000 $6000 $6000
One day dedicated user training via the internet $1200 $1200 $1200
One-half day dedicated administrator training via the internet $600 $600 $600
One and a half days training in your offices $2400 $2400 $2400

* 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 $23000 $230
200 P-1 $23000 $115
250 P-1 $23000 $92
300 P-1 with additional case fees $26400 $88
400 P-1 with additional case fees $33200 $83
500 P-2 $36000 $72
600 with additional case fees P-2 with additional case fees $39800 $66,333
750 P-2 with additional case fees $45500 $60,667
1000 P-3 $52000 $52
1250 P-3 with additional case fees $57500 $46
1500 P-3 with additional case fees $63000 $42
1750 P-3 with additional case fees $68500 $39,142
2000 Contact us - -

Costs in € EUR

Premium package

P-1

P-2

P-3

Included cases per year – up to
250
500
1000*
Cost per year €20000 €30000 €45000
Additional cases above package limit… per case €60 €30 €20

Options

     
Dedicated server €10000 €10000 €10000
Process driven workflow – per year † €6000 €6000 €6000
One day dedicated user training via the internet €1050 €1050 €1050
One-half day dedicated administrator training via the internet €600 €600 €600
One and a half days training in your offices €2200 €2200 €2200

* 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 €20000 €200
200 P-1 €20000 €100
250 P-1 €20000 €80
300 P-1 with additional case fees €23000 €76,667
400 P-1 with additional case fees €29000 €72,5
500 P-2 €30000 €60
600 P-2 with additional case fees €33000 €55
750 P-2 with additional case fees €37500 €50
1000 P-3 €45000 €45
1250 P-3 with additional case fees €50000 €40
1500 P-3 with additional case fees €55000 €36,667
1750 P-3 with additional case fees €60000 €34,285
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 (€).

 

 

 

 

 

 

 

 

 

 

 

 

With the “Premium” PV247 package from Assured 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 need to:
    • add your company products
    • add additional user profiles 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 that you have a different username for your test system
  • 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 PV-Works software package is pre-validated. However, please refer to our validation section for further information on integrating this solution into your own validated system