Case Studies

CASE STUDY

Comparative Signal Detection Analysis

Project Profile

Project for a mid-size biopharmaceutical company utilizing excel spreadsheet and no capabilities to run comparative analysis with FAERS and other external databases.

10 + products and a user base of 50 + users in North America and Europe.

4-month accelerated project implementation to satisfy regulatory requirement including, validation, training and post go live support activities.

Customer has new product launches and did not have the capability to run comparative analysis with competitor product safety data available in external databases such as FAERS.

Current State

Automated comparative analysis using industry standard disproportional algorithms for comparison of safety data in customer internal safety database with external databases.

Ability to respond to HA requests for comparative safety profile analysis.

Automated generation of signal reports with assessment and summaries.

Dashboards and reports with audit trail tracking all activities from discovery to opening signal to processing and close out with recommendation for actions.

Track decision log, review and approval history for complete traceability.

Key Benefits

Automated process to quickly perform comparative review and analysis.
Proactive signal management using alerts and notifications based on threshold and criteria.
>50% automation using workflow and task management.
Improved compliance and consistency of information across signal, risk and aggregate reporting functions.
Automated reporting and metrics.
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