Case Studies

CASE STUDY

Signal Data Analysis and Report Automation

Project Profile

Project for a top 20 biopharmaceutical company looking to link signal detection, data analysis and report generation functions.

25 + products, user base of 100 + users in North America and Europe.

6-month project implementation including data import, validation, training and post go live support activities.

Customer utilized multiple tools, manual steps in the process resulting in inconsistency, duplication and errors.

Manual generation of signal reports & listings.

Current State

End-to-End signal process from discovery, data analysis, report generation to flow of information into the respective aggregate reports.

Ability to track PRAC request, associated data analysis and signal workflow.

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.

Automated flow of signal and risk control activities into the respective section of the PBRER.

Key Benefits

Automated flow of signal and risk control activities into the respective section of the PBRER.
Elimination of manual errors and compliance with templates and quality standards.
70% automation in the production of Signal reports.
Proactive signal management using alerts and notifications based on threshold and criteria.
Full traceability, decision log and audit trail of all activities, decisions made available within the system.
Improved compliance and consistency of information across signal, risk and aggregate reporting functions.
Fully automated reports and metrics for inspections and audits.
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