Pharmacovigilance solution for a streamlined pharmacovigilance workflow.

Maximize potential to minimize the risk

• Assurance of safety due to the system’s compatibility with all applicable pharmacovigilance regulations
• Developed in close collaboration between experts who are working on day to day basis in a pharmacovigilance-based environment and IT developers developer-a
• ICH E2B R2/R3 protocol compatible
• An extensive dashboard/notification system that keeps track of everything, giving you a clear view of your tasks, actions or deadlines
• Entry and grouping of literature findings according to various criteria (e.g. PSUR-relevant, RMP-relevant…)
• No case limit basis
• An option to enter and track PV-related data for multiple clients at once
• An option of detecting potential duplicate cases
• User-friendly interface and easy access to all pharmacovigilance functions
• Specific and unspecific data filtering options, which are especially useful for signal management
• Quantitative and qualitative signal detection options
• The option of generating an activity report which integrates all of the pharmacovigilance-associated data entered in a certain time period
• Automated case delivery (safety messages) to the specified recipients according to the specified requirements
• Export data in various formats (XLSX, XML, PDF…)
• Import safety messages and individual cases in the XML data format
• Audit trail of data entries

• User roles designed to define and simplify the case processing work-flow
• An option to attach any case-related files in a given case entry
• Case life-cycle option
• A lock option for ICSRs which makes the case read-only and it can’t be tampered with
• Creation of links between a literature finding and a corresponding case entry
• Medicinal products and substances entries
• Mail module which allows for the tracking of all kinds of received and sent messages (snail mail, e-mail, fax…) important to the client
• Archiving option for inactive clients
• Recover soft deleted objects option, such as literature or case entries

The cloud-based architecture eliminates the need for local IT maintenance, scales automatically to your volume of use, and ensures best practices considering security and compliance.

Every customer has a separate application instance, monitored and backed up daily, as well as a separate test application instance for testing purposes.

Communication with the server is exclusively using an encrypted HTTPS protocol, all data modifications are audited and previous versions kept, so your data integrity and confidentiality is ensured at every step.

The application is compatible with all major web browsers supporting HTML 5 on all platforms, so there are no additional equipment or software expenses required.

• Implementation – a 1-month process with 4 pre-defined phases
  • current system analysis
  • installation/migration
  • testing
  • online education
• Up-to-date application/database validation documentation
• 24/7 phone / e-mail / live chat support