Streamlined safety signal tracking with a
validated entry process for drug safety
Report information on possible safety signals when the
drug-event pair is unknown or incompletely documented.
Safety Signal Tracker is an end-to-end solution that provides a real-time view into signal management activities from signal identification to signal resolution and closure.
The database-backed web application guides your team through a validated entry process so your team won’t miss anything the regulators require.
SIGNAL IDENTIFICATION STRATEGY
Capture signal information: source, designation, status, signal review and stakeholders. Identify and prevent duplicates, maintaining data accuracy and completeness. Efficiently search and filter on any field or status in the system. Integrate with home-grown and COTS safety systems.
Receive automatic notifications about approaching deadlines and milestones. Stay on top of changing regulations by leveraging an application with built-in institutional knowledge of the unique requirements set forth by international regulators.
Making great decisions requires a great data mining tool. With AgilePV's PV Analytics software you can dynamically visualize AE reports: identify signals, uncover emerging patterns, and recognize possible trends.
Keeping on top of post-marketing surveillance has never been easier.
SEAMLESS REPORTING & COMPLIANCE
Automatically launch internal investigations when signal tracking activities go off-track, to notify stakeholders and managers, and keep an audit trail of processes. Satisfy global and local regulatory standards by generating region-specific reports.