We started TrialNexus because we watched the waste.
Clinical trial teams are some of the most rigorously trained professionals in medicine. They spend most of their day reconciling spreadsheets. That is not a training problem. That is a tooling problem.
People were never meant to be middleware.
For thirty years, clinical data management has asked brilliant people to be the connective tissue between systems that won't talk to each other — hand-carrying a trial's data from protocol to CRF to SDTM to Define-XML, one format at a time.
We think the line is drawn in the wrong place. Software should carry the data. People should carry the judgment — the decisions that take expertise, the answers a regulator will ask for, the calls that move a trial faster.
TrialNexus draws that line and holds it. Agents take the translation. Every output still passes a human before it counts.
Four non-negotiables.
A human at every helm
We will never ship an autonomous-by-default agent in clinical trials. The dial starts in Manual — full oversight. You choose when to move it. Every output your DM lead approves carries their signature, not the agent's.
CDISC or it does not count
If an output is not valid SDTM, ADaM, CDASH or USDM, we have not shipped. Standards compliance is the product, not a feature. Define-XML that passes Pinnacle 21 on the first run. That is the bar.
Every decision has provenance
Agents show their work. Source passages, prompts, model versions, and approvals are immutable artifacts. Not metadata, not an afterthought. An audit trail your regulatory reviewer can follow without a guide.
No data lock-in
Your data stays in your systems. USDM makes protocols portable. If you leave us, you leave with everything, every artifact in open formats. We compete on value, not dependency.
Not observers. Operators.
We built the predecessor tools, sold them, and decided to rebuild what they should have been.
The best way to meet us is on a working call.
We'll run your protocol through the pipeline, live — and you'll talk to the people who built it.
Also useful: Field Notes, our founding post, the iOS Decision Queue, and terms, privacy, and DPA.