Our proprietary solution, PV Monitor, allows you to proactively monitor individual Case Safety Report (ICSR) handling and submissions to Health Authorities and Business Partners.
Monitor case processing performance
Track on-time and late submissions
Perform root-cause analysis
Produce interactive dashboards
Draw from a library of standard reports
Why Choose PV Monitor?
Helps reduce costs and allows resources to be assigned to other tasks
Rapidly deployed in 4-6 months, eliminating manual processes, thus leaving time for more value-added tasks, such as data analysis. Level of effort for compliance report generation and analysis can be reduced by at least 50%.
Improves data quality and consistency of information
Streamlines and simplifies the process for compliance monitoring and CAPA tracking.
Provides the ability to clearly determine the effectiveness of CAPA activities.
Improves compliance process optimization
Our business process consultants will evaluate your current departmental workflows, define an idealized process and develop a custom implementation plan.
More Features that Make PV Monitor a Great Choice
Designed to automatically calculate case process performance metrics
The on-time rate for key case processing steps (collection, processing, and submission) and on-time rate for each organization (affiliates, processing centers, CROs, licensing partners, etc.) facilitating root-cause analysis for late cases
Advanced user interface
Offers interactive and configurable management dashboards with graphical reports
User roles and permissions
Offers role-based security
Data optimization
Centrally captures the reason, responsible organization, and corresponding CAPA for the late metric of each case
User notifications
Configures an Inbox (based on the user’s role) that displays lists of open activities and creates a worklist related to compliance management
Advanced reporting
Includes a library of reports designed to examine submission compliance, late case investigations, late reason summary, CAPA effectiveness for affiliates, processing centers, CROs, and license partners