Fenix Health is the agentic layer between the source and the EDC. It builds the study, captures the data and clears the queries — with a person approving every step.
Protocol design has software. Statistics has software. Submission reporting has software. The part in between — standing the study up, getting data in, chasing it until it is clean — still runs on hours.
That middle is where most of the budget goes and where nearly every error starts. It is the part nobody automated because it is the hardest, and it is the only part Fenix works on.
Fenix does not replace your EDC or your statistics stack. It takes over the span between them.
Each one runs on its own. Together they remove the manual span of a trial end to end.
Protocol to running study
A protocol becomes a working study in hours instead of weeks. Fenix reads it and assembles the forms, edit checks and visit schedule out of the libraries your team already trusts — then hands the draft to a data manager to approve.
Source to database, untouched
Data arrives from wherever it was created — devices, lab systems, source documents, site systems — and lands in the right field with a link back to the record it came from. Nothing is keyed twice, and nothing arrives without its origin attached.
Issues found and answered
An agent reads incoming data against the protocol, finds what does not fit, and proposes the resolution with its reasoning attached. Your monitors spend their time deciding rather than hunting, and every decision stays on the record.
Clinical software is only as useful as the inspection it survives. Fenix is built for that first and optimised second.
Each field in the database points to the source record it came from and the step that produced it.
Nothing an agent proposes becomes data until a named person accepts it. Approval is the product, not a setting.
Audit trail, electronic signatures and access controls designed against the regulation, not retrofitted to it.
Studies are modelled so the data leaves in the shape your statisticians and reviewers already expect.
We will build it alongside your team and measure what it took against what it takes today.
