Advarra CIRBI

Skip the back-and-forth email chains and start your study in a controlled workspace. Create the study record, add sites, and assign roles in minutes. Upload the protocol and consent materials, then use guided forms to capture regulatory details once and reuse them across sites. Configure branded participant-facing notices and sponsor/site notifications so everyone sees consistent, professional communications. Build submission packages with automated completeness checks, collect compliant electronic signatures (21 CFR Part 11), and lock versions so every change is traceable from draft to approval.

As submissions move forward, reviewers receive a prioritized queue with checklists, criteria, and reference materials in one place. They can annotate documents, ask questions, and request updates within threaded discussions that include sponsors, CROs, and sites—no separate trackers required. Alerts fire only when action is needed, reducing noise while keeping timelines tight. Meeting tools prepare agendas, assign presenters, capture votes, and publish minutes and approval letters instantly. Percent-complete indicators and due date badges make it obvious what’s pending, who owns it, and what’s at risk.

During conduct, manage amendments, safety events, and continuing reviews through purpose-built pathways. For an SAE or unanticipated problem, start from the correct template, link affected sites, attach required forms, and route to expedited or full board review based on rules you control. For an amendment, upload tracked changes, highlight consent impacts, and launch a re-consent plan across sites with task assignments and due dates. Coordinators can bulk-upload supporting documents, respond to IRB questions inline, and track completion without spreadsheets. Real-time dashboards display turnaround times, bottlenecks, and site progress, while pre-built reports summarize enrollment and review outcomes for stakeholders.

For portfolio oversight, sponsors and CROs can compare performance across programs, sites, and boards, then drill down to specific submissions with a click. Build custom reports that show cycle times, board outcomes, document currency, and site readiness; schedule delivery to inboxes or export when auditors ask. Role-based access keeps sensitive information restricted; two-factor authentication, validated e-signatures, and an immutable audit history support inspections and internal QA. When an audit hits, pull a complete chronology of submissions, determinations, communications, and signatures—organized, searchable, and ready to share.