Signant Health has launched a new electronic diary (eDiary) data capture solution, which has been developed in partnership with The Epilepsy Study Consortium.
The solution simplifies the experience for patients and study sites that take part in epilepsy trials and ensures robust outcome assessment data for supporting endpoints of the trial.
In addition, the patient-reported outcome measure provides a standardised solution to clinical research sponsors and organisations for obtaining common elements related to seizure data.
The Epilepsy Study Consortium president and founder Jacqueline French said: “We chose Signant as a partner based on their considerable experience developing complex eDiaries and conducting epilepsy trials.
“This new electronic seizure diary combines scientific best practice with clinical requirements to ensure capture of robust and relevant clinical outcome assessments.”
Comprising two configurable eDiaries that are pre-designed, the electronic seizure diary solution enables sponsors to harness electronic data collection benefits and standardise their measurement approach to the seizure events evaluation.
The eDiary’s features can be adapted by research teams to accommodate specific study requirements and maintain a common data set structure.
This ensures complete adherence to protocol and regulatory requirements and promotes retention of participants.
Signant Neurology clinical vice-president and therapeutic-area leader Lew Fredane said: “We have deployed electronic data capture solutions for more than 50 epilepsy trials, so we knew that it would be critical to accommodate the unique needs of epilepsy trial participants who include not just adult and pediatric patients, but their caregivers and study partners as well.”
Working with TESC and partners for one year, scientific experts and software development architects from Signant ensured that the resulting eDiary solution streamlines the participation experience for everyone taking part in trials for epilepsy.
The electronic seizure diary is currently available and can be deployed on Signant’s SmartSignals eCOA platform.
In September last year, Signant Health introduced its Cloud-based Temperature Excursion Management platform within its clinical supply chain management solution portfolio.