Safety Data Management

The primary goal of our services engagements is for clients to feel confident of their ability to execute their safety strategy by having the right tools and the right team in place. We help our clients meet this goal by providing a broad range of services — from traditional installation, validation and training to more customized offerings such as data standards implementation, data migration and data warehouse construction.

Phase Forward's Lincoln Technologies safety division employs a rapid application development approach to develop custom applications and can often leverage the standard software development architecture of our Empirica™ Signal (strategic pharmacovigilance) and WebSDM™ (applied data standards) products. This approach is based on a 3-tier architecture that deploys a thin-client or no-client, a Java-based application server, and an Oracle database. It is easily integrated into most system environments.

Data Subscriptions

Phase Forward's Lincoln Technologies is a reseller of both the FDA’s AERS and the WHO’s Vigibase adverse event experience databases. The raw safety data that are available from regulatory agencies and health authorities are often delivered in a series of uncoordinated quarterly updates that can be difficult to use for quantitative analysis. To make data more suitable for data mining, Lincoln Technologies conducts a substantial data cleaning operation to prepare a proprietary version of these post-marketing safety databases:

  • AERS — drug and biologic product adverse event cases reported to FDA (1968 to present)
  • VAERS — vaccine adverse event cases reported to CDC and FDA (1990 to present)
  • Vigibase — drug and biologic product adverse event cases reported to WHO Uppsala Monitoring Centre (1968 to present)

To prepare these data, Lincoln Technologies:

  • Integrates incremental releases into a single cumulative database
  • Harmonizes MedDRA coding of adverse events throughout the cumulative database across dictionary updates
  • Identifies and flags duplicate cases
  • Translates verbatim drug descriptions into a controlled vocabulary of trade and generic names

We offer subscriptions to periodic (typically quarterly) updates of these prepared data for use with commercial and custom software applications.