Question 1

Is TrialNexus a replacement for my DM team?

Accepted Answer

No. TrialNexus is designed to amplify your data management team, not replace it. Every agent in the pipeline produces proposals — your DM lead reviews and approves them. The goal is to eliminate the translation and waiting work so your team can focus on the decisions that require their expertise.

Question 2

What has been the regulatory guidance on AI use in clinical trials?

Accepted Answer

The FDA's 2023 discussion paper on AI/ML in drug development and the EMA's 2023 reflection paper both reach the same conclusion: AI-assisted processes are acceptable when they are transparent, validated, and human-supervised. The key requirement is that a qualified person reviews, understands, and takes accountability for every AI-generated output. That is exactly what the Decision Queue and audit trail provide.

Question 3

Does it handle our specific EDC (Medidata Rave / Veeva Vault)?

Accepted Answer

Yes. Core integrates with both Medidata Rave and Veeva Vault via their standard APIs. EDC integration is included in every production engagement and is part of the onboarding scope.

Question 4

What does a pilot engagement look like?

Accepted Answer

A four-week fixed-fee engagement. You provide one protocol. We run the full pipeline: Protocol → USDM, DMP, eCRF draft, SDTM map on sample data, and Define-XML. You get the outputs, the Decision Queue trace, and a Part 11 validation package. The pilot fee is credited toward your first production engagement.

Question 5

How does TrialNexus handle 21 CFR Part 11 compliance?

Accepted Answer

Every inference call is logged at the token level in an append-only audit store with agent ID, model version, tenant identity, and timestamp. Every output routes through a human-approval gate before it can influence downstream artifacts. Deployment ships with IQ/OQ/PQ documentation generated from the agent's own audit trail.

TrialNexus — The AI operating system for clinical trials