From protocol activation
to closeout — on one
auditable platform.
Orbitrials connects sponsors, CROs, and clinical sites on a single system. Manage participants, visit schedules, CRF data, ICF compliance, inventory, delegation logs, and regulatory documents — with a complete audit trail on every action.
ICF Version Control
Track informed consent versions and amendment re-consent — never miss a compliance gap.
CRF & Data Queries
Capture visit data, raise data queries, and keep every change linked to the full audit log.
EDC Auto-Bridge
Export eCRF data as CDISC ODM 1.3.2 XML to any connected EDC system with one click.
21 CFR Part 11 Ready
Dual-signature delegation logs, e-signature audit trail, and append-only audit tables throughout.
Enrollment & Metrics
Live charts for screen failure rate, enrollment velocity, and completion — updated in real time.
FDA Certification Letters
Generate 21 CFR Part 11 source certification letters for each site with a single click.
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