Improve Drug Safety Quality Assurance Process

Client

 A $40+ Billion biopharmaceutical company that discovers, develops, manufactures, and sells healthcare products worldwide.

Project Goals

The company desired a faster and more efficient method to ensure the quality of Adverse Event information being provided to regulators.

• Eliminate the need to continually increase staff in response to Adverse Event report growth
• Improve ability to meet regulatory timing requirements
• Increase consistency of Adverse Event reviews

Deliverables

This project delivered:

• A new Quality Assurance process
• A new workflow and database application supporting the new Quality Assurance process that leveraged stratified random sampling methods
• A Continuous Improvement process based on database-supported metrics
• Process and information technology training

Results

• Headcount associated with quality reviews was reduced by 50% while Adverse Event volume increased 75%
• A five-year NPV of over $10million