Signal Management

Streamlined safety signal tracking with a
validated entry process for drug safety


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.


growth

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.
notification

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.


Record information on potential signals when the drug-event pair is unknown or not documented.


footprint

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.”
— Top 10 Global Pharma Client