Foresight® Signal TrackerForesight® Signal Tracker is a proprietary solution developed, hosted and managed in the FORESIGHT® Cloud to enable compliance with regulatory obligations to proactively manage safety signals from their initial identification through to decision on action. The system provides a configurable workflow environment to capture all key attributes of a signal including the client-specific signal status terms.
Foresight® Signal Tracker enables companies to meet the requirements of EMA Module IX on signal management and provides ‘at a glance visibility’ of signal status for each product. The solution provides the best practices from our experience implementing signal management processes for a wide range of pharmaceutical company clients. The solution comes pre-configured with management reports and metrics required for world-wide use by your signal management and product responsible teams.
FeaturesForesight® Signal Tracker provides an integrated, world-wide and on-line solution that:
- Can be configured to take action based on signal status including requests for management approval of status changes and capture of approval / rejection with reasons
- Captures all signal-related activity, including allocation of actions to their owners and records due/actual dates and the status of each action
- Enables documentation to be attached to the signal record to provide a repository of all reports created for the signal and as evidence to support status changes
- Provides full audit reports to show each change of signal status together with the evidence that was used to support the decision and the person responsible for that decision
- Provides out of the box flexible reporting to enable oversight of signal status by product or by category of status as well as custom client-defined reporting as required
Customers accesses the application via secure internet connection to the FORESIGHT® Cloud.