TrialNexus Signal: trial briefs for every function.
Daily, weekly or monthly trial briefs in 60 seconds, not two days, for clinical data management, clinical science, medical monitoring, trial operations and trial monitoring. Enrollment, query aging, data cleanliness and safety, cited to EDC and SDTM. Every function opens the same URL and gets its version of the trial.
What a trial brief should already include.
Signal is not a new warehouse. It is a narrated read of the data you already have (EDC, SDTM, AE registry, IRB) written for the person who has to act on it.
Enrollment & sites
Pace by site, screen-fail reasons, monitoring-visit readiness, and the two sites that are actually slipping, not a chart you have to interpret.
Safety & queries
AE clustering, SAE clocks, query aging, and MedDRA PT distributions with SDTM variables cited inline. The Medical Monitor edits a draft, not a blank page.
Submission readiness
Live Pinnacle 21 status, ICH E6(R3) deviation categories, and audit-trail excerpts that can go in an inspection binder without a late-night scramble.
One read layer. Every role sees their version of the truth.
Signal is not six dashboards in a trench coat. It is one data layer rendering the view each function actually needs, with the narrative already written from the same source of truth. Tap any card to read an example.
Trial Operations & Monitoring
see example →Enrollment pace by site, protocol-deviation heatmaps, monitoring-visit readiness, screen-fail root causes. The site narrative that used to take a PM two days. In 60 seconds.
Medical Monitor
see example →Lab-trend anomalies, AE clustering, dose-response curves per arm. Auto-drafted safety narratives for DSMB and IRB, with SDTM variables cited inline. The Medical Monitor edits a draft, not a blank page.
Biostatistics
see example →Cohort slicing without SAS tickets. Every chart carries its derivation back to ADaM. Every number you see, you can defend, because the derivation is attached.
Regulatory & QA
see example →Pinnacle 21 checks as a live gauge. Protocol deviation logs cross-referenced to ICH E6(R3) categories. Audit-trail excerpts ready for inspection binders, not assembled the night before.
Safety & Pharmacovigilance
see example →Real-time SAE intake, expedited-report timers, MedDRA PT distributions. Auto-drafted narratives pre-filled from source. You edit, not transcribe. Every SAE accounted for.
Executive & Portfolio
see example →Portfolio rollups across trials, sites, countries. What to brief the board. What is slipping. What needs a decision now. One narrative per program, on the cadence you set, written from live data, not a consultant deck.
Already running Core? Signal turns on in days.
Signal sits on top of the Core audit trail. If your DM team is already running the pipeline, your data management, clinical science, medical monitoring and trial operations leads can have live narratives within a week, with no new data contracts and no new EDC connections. If you're starting fresh, a two-week pilot gets you your first trial brief.
The chart you used to stare at, explained.
Every dashboard in Signal has a narrative layer. Agents synthesize the view the moment it loads: what changed, why it changed, what needs a decision. Every sentence carries its citations back to the source.
Scheduled narratives
A briefing per study, per portfolio, daily, weekly or monthly. Written from live data in 60 seconds. Not a consultant deck assembled over two days. Editable in place; regenerable on demand.
Ask Signal
Type a question. Get a sourced, defensible answer, with the underlying chart and the SDTM variables cited. No SQL, no SAS ticket, no waiting.
Provenance inline
Every number in every narrative is clickable. See the derivation, the source row, the agent that produced it, the human who approved it.
Role-aware views
The medical monitor opens Signal and sees safety. The exec opens the same URL and sees portfolio. Same data, same audit trail, different rendering.
Two weeks. One live study.
Signal sits on top of clean data, so pilots are fast. If you're already running Core, we can turn Signal on in days. If you're not, a two-week engagement gets you the first narrative on one active trial.
Ingest + roles
We connect to your EDC (Rave or Vault) and your safety / IRB feeds. We configure role views with your Clinical Ops, Medical, and Regulatory leads.
Narratives + handoff
The first narrative goes live. Your team reviews, edits, and signs off. We hand over the playbook for your team to own it.