Essentials

  • Product description

  • Pricing

  • Payment terms

  • Roadmap

Waith our PV-Works Training Videos

“Essentials” provides core pharmacovigilance in an easy-to-use system for customers with any number of cases up to 500 per year.

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

The Essentials 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
  • 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
  • Ad hoc / on demand workflow tasks
  • Store external documents as part of the case record

  • Pre-validated software
  • Regulatory compliant audit trail

  • Any number of users

  • On-line support and training videos
  • Email support available

  • 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

  • Essentials suits companies with 1 – 500 cases per year
  • Fixed annual cost model
  • Essentials is implemented as a pre-configured version of Assured’s PV-Works software

Select your currency

Costs in $ USD

Essentials package

E-0

E-1

E-2

Included cases per year – up to
50
100
250
Cost per year $6000 $10000 $18000
Additional cases above package limit… per case $120 $100 $72

Options

   
One day dedicated training via the internet $1200 $1200 $1200
Telephone support per year $1600 $1600 $1600

 

Sample Price Plans

Cases per year

Recommended package

Total cost

Average cost per case

10 E-0 $6000 $600
50 E-0 $6000 $120
80 E-0 with additional case fees $9600 $120
100 E-1 $10000 $100
150 E-1 with additional case fees $14500 $97
200 E-2 $18000 $90
250 E-2 $18000 $72
275 E-2 with additional case fees $19625 $71
300 E-2 with additional case fees $21500 $71
400 E-2 with additional case fees $27500 $69
500 E-2 with additional case fees $34250 $69
600 Premium    

Costs in € EUR

Essentials package

E-0

E-1

E-2

Included cases per year – up to
50
100
250
Cost per year €5500 €8500 €15000
Additional cases above package limit… per case €110 €80 €60

Options

     
One day dedicated training via the internet €1100 €1100 €1100
Telephone support per year €1300 €1300 €1300

 

Sample Price Plans

Cases per year

Recommended package

Total cost

Average cost per case

10 E-0 €5500 €550
50 E-0 €5500 €110
80 E-0 €8800 €110
100 E-1 €8500 €85
150 E-1 with additional case fees €12500 €83
200 E-2 €15000 €75
250 E-2 €15000 €60
275 E-2 with additional case fees €16500 €60
300 E-2 with additional case fees €18000 €60
400 E-2 with additional case fees €24000 €60
500 E-2 with additional case fees €30000 €60
600 Premium    

You will pay annually for your “Essentials” 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 “Essentials” 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 will need to:
    • add your company products
    • add additional user accounts if required
    • start entering and reporting cases!
  • You can use your Essentials system immediately for either test or production cases. If you add test cases these may be deleted before first production use
  • 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 features for further information on integrating this solution into your own validated system