Platform
Every capability below reads and writes the same audited records. The study definition drives capture, the participant app, operations, binders, and budgets, so nothing is re-entered and nothing drifts.
Design the study once and every module runs from it.
The study definition is the single source of truth. Build the visit schedule, forms, edit checks, consent versions, and review rules in one visual builder, and data capture, the participant app, scheduling, and budgets all run from the same definition.
Capture once at the point of care. Review on the same record.
Sites capture source data electronically during the visit, and sponsors review the very same records. The eSource-to-EDC transcription step, and every error it creates, is gone.
Participant-reported outcomes on the device already in their pocket.
Diaries and questionnaires schedule themselves from the visit calendar, remind participants over push and SMS without exposing PHI, and capture entries offline with the original device timestamp preserved as source data.
Versioned consent with Part 11 signatures and automatic re-consent.
Consent documents are versioned study artifacts. When an amendment changes consent-relevant content, every affected subject is flagged for re-consent at their next visit, automatically.
Site operations: scheduling, recruitment, enrollment, monitoring.
Everything a research site juggles daily, in one calendar-centered workspace that already knows the protocol: visit windows, enrollment targets, recruitment pipeline, and monitor visits.
eISF binders tied to real roles, real documents, real expirations.
Per-study binders structured on the eISF reference model, with placeholder slots for every expected document, expiration tracking that warns before a lapse, and a completeness score a coordinator can act on.
AE to SAE to expedited report without leaving the dataset.
Adverse events are captured on study forms with structured severity, causality, and outcome. Serious events start expedited clocks with escalating notifications, and reconciliation against CRF data is a query, not a quarterly project.
Budgets accrue themselves. Participants get paid the same day.
Because visits are captured in the same system, finishing a visit accrues the receivable and the participant stipend on its own. No end-of-month reconstruction from shadow spreadsheets.
Dashboards per persona and a report builder over one model.
Every module writes to one data model, so reporting is native. Site staff see today's work, sponsors see enrollment against projection, and networks compare site performance, all live.
FHIR in. CDISC out. An open API in between.
Your data is yours, in standard formats, over a documented API. Migrate in from legacy systems over ODM-XML, prefill from the EHR over FHIR, and export submission-ready SDTM.
Audited access control and a validation package per release.
Access is deny-by-default, study-scoped, and role-scoped, with every grant audited. Compliance posture is a dashboard, and the validation evidence behind each release is generated, not assembled by hand.
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