Upload a protocol. Get a complete data management package — DMP, eCRFs, SDTM mappings, edit checks, ODM-XML export. All CDISC-native. All USDM-anchored. All audit-ready. Built on execution orchestration, not bolted-on automation.
From protocol upload to database lock — every step faster, every decision traceable, every artifact compliant. Not because the AI replaced your team. Because it finally gave them the tools they deserve.
All examples below are illustrative demo data from a representative study.
The Protocol Parser reads like your best data manager — extracting study design, visit schedules, eligibility criteria, endpoints, and every data element into the Unified Study Definitions Model (USDM). Structured, confidence-scored. Under a minute.
Your DM reviews the extraction, corrects the 5% the AI flagged as uncertain, and approves. What used to take days of reading takes minutes of reviewing.
A complete DMP — not a template with blanks. Data collection procedures, validation rules, query management strategy, database lock process — all derived from protocol context.
Your DM reviews against sponsor SOPs, adjusts query escalation thresholds, and signs off. Authorship in minutes, not days.
Demographics, Vital Signs, Adverse Events, Labs, Tumor Assessments — each with correct data types, validation logic, and CDASH mappings. Standards-aligned specifications generated from your USDM, not generic templates.
Your DM previews forms, adjusts field ordering for site preferences, adds a custom assessment the protocol implied but didn't explicitly state.
Every variable mapped to its SDTM domain with confidence scoring. Full provenance tracking from protocol source to final mapping. High-confidence items auto-approved at your chosen autonomy level.
Your DM reviews flagged mappings, sees the agent's reasoning, agrees or overrides. Every decision logged with rationale.
The agent proposes edit checks derived from protocol logic — range checks from eligibility criteria, cross-form consistency rules, conditional logic from the study design. Generated and tested.
Your DM reviews proposed checks against historical query patterns from similar studies, tunes sensitivity, and activates. Institutional knowledge meets AI-generated logic.
Generate ODM-XML — the industry standard — and push directly to Medidata Rave or your existing EDC platform. Study metadata, forms, edit checks, mappings. All validated against ICH E6(R3) requirements. All production-ready.
Your DM runs the pre-go-live checklist, confirms with the sponsor, and hits "Deploy." A ceremony that used to come after weeks of work now comes after an afternoon.
Setup is just the beginning. During the study, your DM team works with agents daily. The agents triage overnight data loads, resolve routine queries, and surface the decisions that need expert judgment.
Auto-resolves straightforward queries, surfaces complex cases with suggested resolutions and supporting data context.
Watches for protocol deviations, missing data patterns, and site-level anomalies in real time — not in Friday batch reports.
Keeps external data (labs, IRT, eCOA) in sync, flagging discrepancies before they become audit findings.
Runs pre-lock validation, completeness checks, generates final SDTM datasets. Your DM reviews and triggers lock with confidence.
Your DM opens TrialNexus each morning to a prioritized task stream. The agents have already triaged overnight data loads, resolved 80% of routine queries, and surfaced the 20% that need expert judgment. Your DM makes decisions. The agents execute them.
Setup in an afternoon. Operations on autopilot.
Database lock — on time, every time.
That's giving them a superpower.
TrialNexus converts protocol intent into USDM, generates compliant artifacts, and orchestrates deployment into live EDC systems.
Representative views from the DM workflow. Full demo available on request.
USDM extraction with confidence scoring and review workflow.
Automated checks derived from protocol logic and prior studies.
See protocol to production database in minutes.
Sarah opens TrialNexus on her phone. Three studies, one notification: "Study 204 — 12 queries auto-resolved overnight. 3 require your input." She swipes through the three, approves two, escalates one to the medical monitor. Done before coffee.
The Data Quality Monitor flags an anomaly: Site 042 has a high rate of "Not Done" entries for vital signs. Sarah reviews the pattern, writes a note to the CRA, and adds an edit check. The agent implements it in real time.
A new study lands. Phase III oncology, 400 pages. Sarah uploads the protocol. By 4:15, she has a draft DMP, 28 eCRFs, and SDTM mappings with confidence scores. She'll spend tomorrow morning reviewing. Her old timeline: three weeks.
Fewer meetings. Faster decisions. More trials moving forward.
The Human Agency Dial isn't about trust. It's about workflow. Running a mature Phase IV? Go Autonomous. First-in-human with novel endpoints? Full Oversight. Most days, you'll live in between.
Review every decision. The agents accelerate your work, but you approve each step.
Agents handle high-confidence items. You verify everything else. The sweet spot.
Agents drive, you audit results. For well-mapped domains and mature study types.
Regardless of your setting, if an agent's confidence drops below threshold on any decision, it automatically escalates to human review. No override. No silent failure.
The agents know what they don't know.
Every decision logged. Every override recorded. Every reasoning chain preserved.
Built for 21 CFR Part 11. Designed for the audit you know is coming.
We're partnering with CROs and pharmaceutical companies who believe their teams deserve better tools.