eSAE
Optimize efficiency in safety reporting with eSAE.
Our platform empowers investigators to access comprehensive safety information seamlessly, accelerating event reporting processes. Benefit from a flexible solution that adapts to your needs, ensuring swift and compliant reporting of SAEs and pregnancy notifications.
The eSAE module allows investigators to have all the safety information in a single container speeding up the procedures for creating, sending and reporting of the event.
Our eSafety Tool empowers users to create SAE forms that align precisely with the unique requirements of each sponsor or study protocol. This customization ensures that every data point essential for accurate reporting is captured efficiently.
Here is how it functions:
The eSafety Tool generates an electronic report (e-report) that seamlessly finds its way to the pharmacovigilance profile. This automated process not only expedites reporting but also guarantees that all pertinent stakeholders are swiftly informed.
For comprehensive record-keeping and regulatory compliance, our tool allows users to save SAE reports in PDF format. This feature ensures a secure and easily accessible archive of all SAE reports, ready for inspection when needed.
Automatic alerts are built in, creating a real-time safety net. Clients receive notifications right from the moment the first adverse event is inserted into the system. This early warning system facilitates rapid response and intervention when necessary.
With our eSafety Tool, everything is customizable. Clients have the flexibility to dictate who receives information and notifications, whether it’s internal team members, sponsors, or regulatory authorities. This adaptability ensures that the right individuals are always in the know.
SAE and Pregnancy forms management
Fully integrated with the EDC
Safety Notification sent by email to the involved users
Possible data import into Safety DB
