ClinTrak® Safety Notification Module (CSN)
The Clinical Safety Team uses the ClinTrak® Safety Notification Module system to facilitate the timely and accurate collection, triage and tracking of all clinical safety notifications and source documentation received. All source information and safety notifications are electronically stored and subsequently retrievable using the CSN search tool.
ClinTrak® Event Adjudication Management (EAM) System
CAC members have 24/7 web-based access for independent review of cases and receive real-time electronic notification when data packages are ready for review. Formal adjudications are entered into the system for inclusion in the final adjudication database with audit trails of the entire process. The result is rapid turnaround of adjudications, in days versus weeks.
ClinTrak® Safety and Pharmacovigilance (CSPV) System
The use of the ClinTrak® Safety and Pharmacovigilance (CSPV) system enhances the ability for the postmarketing safety team 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.