Engage layer · Module 02LucaH®
The study, and the televisit, in your pocket.
LucaH® is the ECS® Engage module. Reminders you can silence, questions in your language, remote consent, iCare content, proxy access, and protocol-driven Televisit built into the same app, so the study visit lives where the participant already is.
LucaH is how participants recognise the app across every study we run, a familiar face that makes clinical research feel less clinical, without hiding what's actually happening.
Participants download LucaH® – no web login.
The daily activity screen, visits, activities and reminders in one glance.
Calendar view of what's coming, televisits, questionnaires, home supplies.
The task feed, surveys, recordings, take-your-pill, video capture.
One-tap encrypted call with the investigator, inside the same app.
Purpose-built, module by module.
Validated instruments, licensed where needed, offline-capable with resync on reconnect.
Granular, revocable consent, including delegated / proxy consent for minors, dependents and care-partners.
Time-of-day, snoozable, translatable, designed to disappear when they should. Participation stays a choice, always.
Where appropriate and agreed, a caregiver can act inside LucaH® on the participant's behalf, with a full audit trail.
Study-specific educational content, video-tutorials and lay-language explainers, plus a virtual assistant that answers routine questions and hands off to the site team when needed, every interaction logged.
Study drug, devices and questionnaires delivered where the participant lives, logistics closed inside the same workflow.
Investigator-supervised virtual visits bound to the protocol, the eCRF and the audit trail, HD, end-to-end encrypted, with identity verification and eSignature (Part 11) inside the same call.
During a call, the site sees the participant, the eCRF and the protocol side-by-side, no switching between video, EDC and paper.
Regulatory & standards frame.
The regulatory and standards backdrop this module is designed against.
Participant-facing evidence, informed-consent evidence and remote visits, investigator oversight preserved.
Framework for decentralised elements including remote consent and televisit.
Remote visit conduct, identity verification and source documentation aligned to FDA decentralised-trial guidance.
Electronic records for televisit recordings, transcripts and e-signatures, full audit trail.
Special-category health data handled with explicit consent, data minimisation and end-to-end encryption.
The virtual study assistant is clearly labelled AI; escalation paths to the site team are logged.
Televisits modelled as FHIR Encounter resources for interoperability with EHRs and study systems.
Accessible-by-default UI, for participants, caregivers and proxies.
Built to be handed to a regulator, with regional data residency in the sponsor's jurisdiction.
The rest of ECS®.
Tell us who you need to enrol.
Send the eligibility criteria and the geography. We come back with a recruitment route: pharmacy, community clinician, hospital or fully digital.