How biotech and pharmaceutical sponsor teams use CTDashboard for safety monitoring, DSMB preparation, and medical review – and what to expect from the platform.
Use case 1
Load your latest EDC export, review safety signals, then export a complete open/closed session DSMB package as PowerPoint – formatted with confidentiality labels and ready to present.
Use case 2
Load this week's EDC extract, point to last week's export as baseline, and the Comparison tab instantly surfaces new AEs, modified records, and emerging signals across all domains.
Use case 3
When a safety signal is flagged, drill down by site, arm, or severity. Cross-reference AEs with labs and conmeds. Export charts and tables for your safety report.
Use case 4
Subject Profile provides a per-patient deep-dive across all domains. Review AE timelines, lab trends, vitals, and add reviewer annotations – all in one view.
Honest positioning matters in regulated environments. Here is where CTDashboard fits in your technology stack.
| What CTDashboard does | What CTDashboard does not do |
|---|---|
| Reads CSV, XPT, Excel, and ODM-XML exports from any EDC system | Does not replace your EDC (Rave, Oracle, Veeva) |
| Auto-detects 14 CDISC/CDASH domains and maps columns | Does not perform SDTM transformations or submissions |
| Provides 12 interactive safety dashboards with clinical highlighting | Is not a validated statistical analysis system (SAS/R replacement) |
| Generates DSMB packages, safety PDFs, and DSUR draft reports | Does not enforce electronic signatures or 21 CFR Part 11 controls |
| Runs rule-based signal detection (Hy's Law, SAE imbalance, site disproportionality) | Is not a pharmacovigilance system (no E2B/CIOMS/ICSR processing) |
| Processes all data locally in memory – zero storage, zero transmission | Does not provide multi-user collaboration or role-based access |
CTDashboard is built with a privacy-first architecture. Clinical data is loaded into application memory, displayed interactively, and discarded when the application closes. No clinical data is written to disk, uploaded to any server, or transmitted externally. Saved workspaces store only file paths and display preferences – never patient data. See the Security & Data Privacy page for the full architecture overview.
CTDashboard is a read-only visualization and review tool. It does not create, modify, or manage electronic records that are subject to 21 CFR Part 11. It has no user authentication, electronic signatures, or system-enforced audit trail. It is designed to sit alongside your validated systems (EDC, IWRS, safety database) as a review and presentation layer – not as a system of record.
CTDashboard includes an automated validation report that independently recalculates every displayed KPI using raw data and compares the results against the application's output. This report can be generated on demand via File > Export Validation Report and reviewed by your QA team. It covers demographics, enrollment, adverse events, labs, vitals, disposition, and survival analytics. The report is a functional verification tool – not a substitute for a full Computerized System Validation (CSV) package.
| Question | Answer |
|---|---|
| Where is clinical data stored? | In application memory only. Discarded on close. Nothing written to disk. |
| Is data transmitted externally? | No, unless AI Patient Narratives is used (optional). In that case, selected subject data is sent to the AI API. The AI provider does not retain it. |
| Does the application require internet? | No. Fully offline except for optional AI Narratives and auto-update checks. |
| Does it collect telemetry? | No. No analytics, no usage tracking, no crash reporting. |
| Does it require admin rights? | No. Installs to user profile. Works on corporate machines with restricted permissions. |
| What does it save to disk? | Workspace files (file paths + config only), field mapping preferences, and reviewer notes. All explicitly marked with _compliance: "No clinical data". |
We recommend this evaluation path for sponsor teams: