Our FDA comment on AI in early-phase trials
FOR CLINICAL TRIALS

Run your trial's data collection on neutral, compliant rails, without making the site a data-and-compliance operation.

AnyBio is the multi-device platform where your study's biosignal data is captured, governed, and delivered as EHR-ready FHIR or HL7v2, with provenance and audit trails throughout. The sponsor funds the instance; the provider site doesn't hold the PHI or build the compliance.

THE PROBLEM

A custom pipeline for every trial, and sites that don't want the custody.

Continuous-monitoring and multi-device studies usually mean standing up a custom ingestion-and-compliance pipeline for every trial, and asking the provider site to take on data custody and compliance they don't want. That friction slows enrollment and scares off sites, and it's exactly the kind of infrastructure a sponsor shouldn't have to build to run one study.

The sponsor funds the instance.

The rail below is the whole model: the sponsor funds the instance, and the provider site participates without holding the PHI or owning the compliance. Data lands structured for the sponsor's analysis pipeline, timestamped, attributed, and auditable. (On regulatory scope: we provide auditable, provenance-tracked, access-controlled collection; for FDA-regulated trials with specific electronic-records requirements, e.g., 21 CFR Part 11, or GCP obligations, we'll walk through what applies to your study and where responsibilities sit. We don't overstate formal regulatory-trial certification we haven't established.)

YOUR DEVICES

SPONSOR FUNDS THE INSTANCE
TRIAL DEVICES CAPTURED
PROCESSOR OF RECORD
SITE HOLDS NO PHI
FHIR / HL7V2 WITH PROVENANCE

CLINICAL SYSTEMS

THE RESEARCH CHANNEL

Matched with a provider site through our research channel.

If you have a study but not a provider site to run it, our research channel can help. Through it, we can route you toward a provider site and stand the study up on AnyBio's rails, sponsor-funded, compliant, and auditable, so both you and the site participate without building the pipeline. (This is a path we can help open, not a guaranteed match; we'll talk through what fits your study.)

WHY NEUTRAL MATTERS HERE

The trial is the entry. The rails stay.

Trials rarely use one vendor's device, so a neutral platform collects across whatever the protocol needs. And the trial is an entry, not a dead end: the same rails the study runs on can carry forward into ongoing research or clinical use if the site wants to keep going after the study ends. Your device or IP moves from proving to deploying on the same platform, without a second integration. The trial is the entry; the rails stay.

Talk to us about your study's data collection.

For sponsors running multi-device or continuous-monitoring studies who want compliant, auditable collection without building it, whether or not you have a provider site yet.

Moving forward together