clinCORE’s Safety system improves the ability for the post-marketing safety teams to effectively manage case workload on a daily basis according to priority, while minimizing compliance risk. The system facilitates electronic capture of incoming and outgoing calls received/made by the call center team as well as allows for the tracking of any follow-up action items requested. The system also provides for product complaint intake, tracking and data basing.
Maintaining a validated safety database across multiple phases or studies is crucial to identifying and proactively managing any safety issues that may arise. clinCORE’s Safety system includes a safety database built into the trial platform that automatically reconciles safety events with the clinical database and allows for tracking of events from any place in the world. Instead of having team members type in the appropriate forms whenever an event occurs, the system auto-populates fields straight from the clinical database, thus reducing the chance of human error. Clinical subject safety data can be analyzed through various types of reports, and AEs can be analyzed in context and tracked across multiple study visits.