Complete Pharmacovigilance Safety System

SafetyBase Interchange is an E2B-compliant database which communicates, receives, sends and manages electronic adverse event reports.

The database is web-based and has been developed using state-of-the-art technologies like .NET. All services run on BaseCon central servers with fully validated backup procedures and 24/7 access anywhere in the world.

SafetyBase Interchange manages key functions, such as automatic selection of communication pathways, auto-labelling, and tracking of submissions. Line listings, Summary tabulations, CIOMS, and MedWatch are fully supported. SafetyBase Interchange is constantly updated to comply with changing legislation and standards. It includes a fully integrated Product Register.

BaseCon offers complete computer centre services to ease implementation. New versions of programs, dictionary updates, and back-ups are all part of the maintenance service.

Key Features:

• Complete Independent Drug Safety Solution
• Auto-Labelling
• Automatic Communication Pathway Selection.
• Submissions Tracking.
• E-mail Controlled Workflow.
• E2B-Compliant Gateway.
• Real-Time Surveillance.
• Simple Web-access.
• Electronic Archive.
• Automated Reporting.
• Option for In-House Hosting.

View the SafetyBase Interchange in action. Click here to view an animated demo

How SafetyBase works
– scenarios A and B

A) A safety report is transmitted and received as an E2b file during electronic communication. Automatic acknowledgment messages are also sent and received in accordance with the standard to ensure documentation for the transmissions.

B) A safety report is entered via the secure website, which offers the option of entering original reports close to the source, e.g. at the affiliate, sales agent, customer or business partner. This minimises the effort and number of errors involved. Further handling of the report is work flow controlled, based on e-mails.

When a safety report is entered or imported into the system it may be forwarded to a medical reviewer via an e-mail link. When the review is completed the system generates the next step in the work flow. Using predefined rules and registrations from the fully integrated Product Register, the system automatically forwards the report to the relevant authorities and business partners.

Easy start
BaseCon offers complete computer centre services to ease implementation. New versions of programs, dictionary updates, and backups are all part of the maintenance service.