Conduct layer · Module 03ViSA
Virtual Study Assistant, led by clinicians.
ViSA, Virtual Study Assistant, is the investigator-supervised study cockpit of ECS®. Televisit, source data, monitoring, e-signatures and a continuous audit trail, the study experience, in one workspace.
Purpose-built, module by module.
Profiling, cohort matrix control and per-participant workspaces, the investigator view of who's in, where they are, and what's next.
Dynamic agenda for study-flow control and participant-visit management, windows, reminders, rescheduling, calendar sync.
Subjects matrix control and live analytics, compliance, adherence, deviations and monitoring flags in one workspace.
Per-participant visit list, on-site, televisit, home visit, with status, modality, duration and outcome for every scheduled event.
Encrypted video visits with the investigator, opened from the visit itself, so consent state, source data and the audit trail are already in the room.
Investigator-side view of participant adherence, ID · IP · Administration checks, streamed as the study runs.
21 CFR Part 11 aligned signatures with role-based scopes and immutable evidence for every clinical decision.
Remote source data review with query workflows, redlines and reviewer sign-off, inspection-ready.
Every event timestamped, attributable and traceable, ALCOA+ by default, sponsor-visible in real time.
Regulatory & standards frame.
The regulatory and standards backdrop this module is designed against.
Investigator oversight preserved across on-site, televisit and home-visit events.
Computerised systems used in GxP, validated states, access control, e-signatures.
Electronic records and signatures, role-scoped, timestamped, immutable.
Critical-to-quality factors surfaced in monitoring dashboards.
Attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring, available.
Remote source data verification with query workflows and reviewer sign-off.
Built to be handed to a regulator, with regional data residency in the sponsor's jurisdiction.
The rest of ECS®.
Bring us your visit schedule.
We walk through how the protocol behaves in ViSA, where the alerts fire and who receives them, on a live instance rather than a slide.