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ClinOps trial intelligence, already narrated.

The Monday-morning ClinOps briefing in 60 seconds, not two days — enrollment, query aging, and safety, sourced to CDISC. Medical, Biostats, Regulatory, and Safety open the same URL and get their version of the trial.

See every function
Auto-narrativesPortfolio rollupsProvenance inline
signal.trialnexus.ai · STUDY-A4471
Weekly narrative · Monday morning
Enrollment is on track at 214/240 (89%), led by Site 007 (+12 this week). Two sites are underperforming: Site 031 has screened one patient in six weeks; Site 044 has paused enrollment pending IRB amendment. Safety profile unchanged week-over-week — no new SAEs requiring DSMB review.
Enrollment
89%
+4.2%
Data cleanliness
96.4%
+0.8%
Query aging
< 5 days
–
Sources: EDC · SDTM · AE registry · DSMB memo · IRB log — all citations inline
Clinical trial intelligence

What a ClinOps weekly briefing 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 Monday morning.

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.

Built for every function

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.

The site-ops newsroom

Clinical Operations

see example →

Enrollment pace by site, protocol-deviation heatmaps, monitoring-visit readiness, screen-fail root causes. The Monday-morning narrative that used to take a PM two days. In 60 seconds.

Signal detection, narrated

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.

Ad-hoc answers, traced

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.

Submission readiness, live

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.

Nothing gets missed

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.

One surface, every program

Executive & Portfolio

see example →

Portfolio rollups across trials, sites, countries. What to brief the board. What is slipping. What needs a decision this week. One weekly narrative per program, written from live data, not a consultant deck.

The OS, in context

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 Clinical Ops and Medical 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 Monday-morning briefing.

Write side

Core

Seven specialized agents. Protocol → USDM → DMP → eCRF → SDTM → ADaM → Define-XML. Artifacts, audit trail, approvals. Study builds in under two weeks.

ParserDMPeCRFSDTMADaMQueriesDefine-XML
Core overview →
Read side

Signal

Dashboards and auto-narratives for every function. Cross-trial, cross-site, cross-role, from the same audit trail. The briefing in 60 seconds.

Clin OpsMedicalBiostatsRegulatorySafetyExec
Signal overview ↑
What the narrative does

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.

Weekly narrative

A Monday-morning briefing per study, per portfolio. 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.

What a Signal pilot looks like

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 weekly narrative on one active trial.

Week 1

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.

Week 2

Narratives + handoff

The first weekly narrative goes live. Your team reviews, edits, and signs off. We hand over the playbook for your team to own it.

Common questions

What ClinOps and Medical ask about Signal.

Signal writes the Monday-morning briefing from live data — enrollment, query aging, safety, deviations — with citations back to EDC, SDTM, and the audit trail. Dashboards show charts. Signal narrates what changed, why it changed, and what needs a decision. Each role (ClinOps, Medical, Biostats, Regulatory, Safety, Exec) opens the same URL and sees their version of the trial.
Clinical Operations, Medical Monitors, Biostatistics, Regulatory & QA, Safety / Pharmacovigilance, and executives who need a portfolio rollup. It is the read layer of the TrialNexus OS, not a separate data warehouse.
If Core is already running, Signal turns on in days against the same audit trail — no new EDC connections. If you are starting fresh, a two-week pilot on one live study produces the first weekly narrative.
Two weeks, one live study. Week 1 connects Rave or Vault plus safety / IRB feeds and configures role views. Week 2 ships the first weekly narrative; your team edits and signs off, then owns the playbook.

One trial. Two weeks. Live narratives.

If Core is already running, Signal can be live in days. If you're starting fresh, two weeks to your first Monday-morning briefing.

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