A mid-sized global biotechnology company dedicated to revolutionizing cancer care is replacing its current signal management in-house tools and processes. They currently utilize spreadsheets and various tools and applications in a largely manual process to meet signal tracking and reporting demands. They are deploying PV Signal to drive compliance and provide oversight to meet regulatory requirements.

They chose PV Signal to address the following requirements and improve existing processes:

• Using the system to trigger real time alerts on safety data to detect signals and tracking of signal review/decision
• Analysis of aggregate data for signals and tracking signal review and decision
• Drill down to individual case level details for cases of interest
• Documentation of data used to make decisions to support signal management
• EVDAS Review
• FAERS Ad-hoc review
• Identify and analyze safety signals (visualizations, data mining, integrated statistics)
• Create workflow and management of signals with audit trail
• Automation for signal management

The client did an extensive market review and hands-on evaluation of vendors prior to selecting RxLogix solution.