Streamlined safety signal tracking with a
validated entry process for drug safety
Record information on potential signals when the
drug-event pair is unknown or not documented.
Signal Tracking
Safety Signal Tracker provides a system to track your signal management activities from identification through resolution and closure.
All the while, you'll get a top-down, real-time managerial overview into your team's and your organization's signal management activities at every step.
The validated web application will guide your team through every step of recording and entering potential safety signals, so that you won't have to worry about your team missing any fields that 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.
STAYING CURRENT
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.
Support Signal Identification
Making great decisions requires great insight. With AgilePV's Safety Signal software you can dynamically visualize AE reports: identify signals, visualize 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.
“Our users have expressed a high level of comfort using the modules and the general feedback is that the system is easy to learn and use.”
