Enterprise

  • Product description

  • Pricing

  • Roadmap

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
  • Fully configurable system – vocabularies, pre-defined queries, access permissions, validation rules etc
  • 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

For pricing of the Enterprise option please contact us.

 

 

 

 

 

 

 

 

 

 

 

 

 

With the “Enterprise” PV247 package from Assured 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 Assured 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