Electronic clinical outcome assessments, purpose-built for the indication, delivered by a therapeutic-area team with the trial service around them.
Diaries, patient-reported outcomes and performance measures, designed per indication by people who work in the therapeutic area. They run on Amma, our trial platform.
Dashboards are populated for sites, CROs and sponsors as the data arrives, so a missed entry can be chased straight away.
Instruments are built per indication rather than per therapeutic area. The design method is the same whether the endpoint is a seizure count, a symptom score or a performance measure, and it is the method that moves between areas.
Today the depth sits in rare and developmental epilepsy. Our eCOA is contracted in 18 studies for 13 sponsors, across Dravet syndrome, STXBP1, SCN2A and SCN8A, SYNGAP1, tuberous sclerosis complex, developmental and epileptic encephalopathies, and focal, generalized and absence epilepsy, with sites in North America, Europe, the Middle East, Asia-Pacific and Latin America. Six further eCOA engagements run alongside them as platform licenses, recruitment and consulting work. Work beyond epilepsy has started, beginning with Pitt-Hopkins syndrome.
When a trial closes, the diary does not have to. Participants and caregivers in epilepsy studies can carry on logging seizures in Helpilepsy, our patient app. Helpilepsy is a separate app with its own consent, so the trial consent does not change. The sponsor gets natural-history and post-marketing data on the instrument the trial already validated, and the patient keeps the tool they have learned to use.
The service comes with the platform: project management, translations, IRB/EC submission documents, site training, and a help desk that answers in the participant's language.
A diary configured per indication, so the items a patient records match their condition.
Patient-reported outcome instruments completed by the participant.
Day-to-day symptom capture between visits.
Live study monitoring, data quality reports and site communication.
Dose logging, with titration supported where a protocol needs it.
Compliance tracking, custom notifications, editing and invitations. Covers the HCP cohort view.
Direct and indirect integration with monitoring devices and sensors.
Site exports, custom sponsor exports and raw data export.
Visit and assessment scheduling, with participant reminders.
Recruitment drawing on an established patient population.
24/7 multilingual support for participants, sites, caregivers, CROs and sponsors.
Participant-facing content in the languages a study runs in.
Instrument licensing with certified translations per country.
A single point of contact from start-up to database lock.
A named data manager through to database lock.
Site initiation visits, investigator meetings, site training and train-the-trainer.
Tell us what you are working on and we will point you to the right people.
