Hyper-e-SAE

Hyper-eSAE allows the notification of a Serious Adverse Event (SAE) from the site to the responsible pharmacovigilance officer.

Instead of using the traditional SAE fax form, the investigator will fill in the SAE-related information into the eSAE Report Form. By electronically signing and submitting it, an immediate notification via mail is sent to all the appropriate recipients.

The SAE reports, both initials and follow-up, may be queried via the HyperSuite® e-Query system and might be printed or downloaded.

In double-blind clinical trials when the investigator have to break the drug code, the system allows the investigator to request the “Drug Code Un-Blinding” and to receive information about the medication which was administered to the subject(s).

The unblinding procedure will be activated only when the SAE has been previously notified and registered. An alert message is immediately sent to the trial team member(s) when unblinding the  “Drug Code Un-Blinding”, has been  by an investigator.

Hyper eSAE main functionalities:

• e-Notification of SAEs by investigators to pharmacovigilance officer
• Integrated patient identification code  and tracking of data across clinical and safety database
• Improvement of data consistency across clinical and safety database via relational connection approaches
• Web based emergency “Drug Code Unblinding” with immediate alert to drug manager or other involved parties

Benefits for the Investigator:

• Better patients safety management
• Better compliance with regard to SAE reporting timeframe
• Easier and faster completion of the eSAE form

Benefits for the Sponsor:

• Real time information on any new SAEs
• Easier  SAEs reconciliation
• Higher protection of the clinical trial participants