The electronic Pharmacovigilance (ePhV) platform is a web-based platform designed to collect clinical data related to adverse drug reactions and replaces the traditional paper-based data collection methodology to streamline data collection and ensure real-time safety event collection and reporting. The solution allows for real time capturing of safety events, linked to a notification platform which in turn alerts the respective safety teams of new events coming in.
Having the ability to track timelines when adverse events are reported is crucial. Our platform allows the user to make use of the "derived calculations" module to calculate specific timelines based on adverse events reported. The platform also then allows the user to setup automated reminders and notification to be sent to the pharmacovigilance team via email, SMS or in-app notifications.
Our Safetybase solution has the ability to alert research teams of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) as soon as they are entered into the system. The solution has the ability to automatically complete CIOMS or MedWatch forms. All of these events can also be linked to automated notifications in the form of emails or text messages to mobile devices.
AUTOMATED LETTER GENERATOR
Our automated letter generation tool is simple yet powerful. It allows you to automatically map information from the system into the configured spaces on the letters. This allows you to generate the letters accurately with the information captured in the system. The letters can be scheduled to send automatically based on events configured by the administrator or the letters can be manually configured and previewed by the system users.
The reporting wizard allows the user to dynamically create reports from different areas in the system using a number of predefined filters. These reports can be exported to PDF or CSV (using either SDTM, Normal or Custom formatting) to be customised further on other platforms.