- Study Builder and protocol versions
- Configure study design, assessments, eligibility, consent, and visits. Track protocol versions and startup checks.
- Draft-study sandbox
- Invite approved team members to test a draft study on real devices before publication. Test enrollments and their records are marked separately from real participation.
- Trial Signal
- Review study-level signals with uncertainty and data-availability context. Access follows study blinding; public signals require eligibility and explicit publication.
- Specimen studies
- Coordinate supported collection, chain-of-custody records, lab accessioning, result ingest, and appropriate result return for single-timepoint studies.
- Recruitment and registries
- Manage recruitment channels, eligibility review, and registry cohorts with study-scoped permissions.
- Randomization and platform trials
- Configure supported allocation methods, blinding, and platform-trial rules within the study’s approved design.
- Monitoring and supplies
- Track risk indicators, deviations, review records, kits, delivery exceptions, and reconciliation.
- Managed data and exports
- Use edit checks, tracked queries, database locks, audit exports, and supported CDISC SDTM / define.xml generation. Validate outputs for your intended use.
- Coding review workflow
- Review and approve coded terms. Licensed MedDRA and WHODrug dictionaries are not connected in the current preview.
- Regulatory records and closeout
- Organize approvals, amendments, reporting obligations, completion checks, and archive records.
- De-identified coordinator views
- Study teams work with study-scoped participant identifiers. Direct participant identity is separated from the coordinator API.