
Trialetics is an agentic clinical trial management system: studies, sites, documents, people, and money in one workspace, with audit trail, role-based access, and a permission-bounded Copilot on top. Run the study. Protocol versions, enrollment, subject visit schedules, milestones, sites, issues, and a live Overview so operations, medical, and finance start from the same numbers. Monitor and verify. Monitoring visit reports (author, review, e-sign, file), findings into the site issue log, SDV tracking, a visit calendar and travel planner, timesheets, and expenses. Documents and TMF. Versioned document management with QC and expiry. A Doc Portal so sites can upload without an account. An eTMF against the TMF Reference Model — completeness, timeliness, QC cycles, inspection readiness, and portfolio rollup. Capture, supply, safety, money. EDC/eCRF. IP and inventory with chain of custody. Safety events with reporting clocks. Study and site budgets, invoices, and payments. The team around it. Directory, tasks, notifications, CRM from feasibility to award, client workspaces, learning and training compliance, resourcing map, custom reports, and branded templates.