TrialNexus Resources: clinical data guides and field notes.
Practical guides on clinical data management, SDTM, 21 CFR Part 11, ICH E6(R3), and agentic AI in clinical trials. Each note is written by the team building TrialNexus. No gated PDFs, no webinar funnel.
Start with the question in front of you. What agentic AI means for a data management team, what ICH E6(R3) requires, and how to review an SDTM map are the notes we send first. The Part 11 checklist is the vendor questions. The full list is below.
Clinical data management and SDTM
Study build, USDM, SDTM mapping, and the submission errors that slow a study down.
What goes wrong in a 68-day study build: a timeline from a real DMP process
Anonymized cycle-time data from conversations with DM leads at six mid-size sponsors.
Why USDM v4.0 is the most important standard in clinical trials, and why nobody is talking about it
A walkthrough of the Unified Study Definitions Model and what changes when protocols are machine-readable by default.
SDTM mapping examples: raw CRF data to SDTM domains
Worked maps from raw CRF data: blood pressure to VS, demographics to DM, and a reported adverse event to AE, then how to review the rest of the map.
The SDTM submission errors that cause Pinnacle 21 failures, and how to prevent them
A breakdown of the most common SDTM conformance failures, why they happen, and what a prevention-first pipeline looks like.
21 CFR Part 11 and ICH E6(R3) compliance
What regulators expect from AI-assisted clinical data work, and how to show it.
Is your AI clinical trial tool actually 21 CFR Part 11 compliant? A checklist.
Most AI vendors claim Part 11 compliance. Here is what the regulation actually requires for AI-generated clinical data artifacts, and the questions to ask before you sign.
What ICH E6(R3) actually requires for AI-assisted clinical data management
A sponsor-side reading of the January 2025 GCP guideline: what an inspector should be able to find, and how that differs from a Part 11 records check.
Building an audit trail you would actually show a regulator
How we designed immutable provenance records on top of Postgres, and the tradeoffs we made for Part 11.
Agentic AI in clinical trials
Where agents help, where humans stay in charge, and how to tune the balance.
Agentic AI in clinical trials: what it actually means for your data management team
A worked Core pipeline from protocol to Define-XML, the line between assisted and autonomous, and the questions that separate a real agent from a slide-deck feature.
Why "human in the loop" is the only viable model for AI in regulated clinical trials
Autonomy and compliance are not opposites, but getting both requires an architecture that most AI tools have not built. Here is what the compliant version looks like.
The agency dial: how to give agents responsibility without losing oversight
The user-interface primitive we keep coming back to, and why it matters more than any model benchmark.
Your enterprise AI is writing emails. It should be closing study builds.
Sponsors pay five figures a year for frontier-model access and point it at meeting notes. Nexus Assistant makes every CDISC-native TrialNexus agent callable from Claude, ChatGPT, or Gemini, with a Part 11 signature behind every approval.
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