Clinical R&D

Audit-ready trials, without the eClinical price tag.

Clinical studies plus the full regulated eQMS evidence chain — CAPA, audits, design controls, risk, change control — with a dataset→model→outcome lineage registry and a grounded trial copilot for AI-driven work.

Built for teams running AI-driven trials who need audit-ready evidence, not a six-figure eClinical suite.

Read-only demo · no signup · sample data only

One platformShared operational data
Role-awareAccess follows responsibility
ConnectedContext follows the record

The problem

AI moves fast. Regulators don't.

The moment a model touches a trial, you owe a lineage and an evidence chain most AI teams have no way to produce.

  1. 01

    The model's lineage is unprovable

    Which dataset trained which model that drove which outcome? If you can't show the chain, an auditor can't accept the result.

  2. 02

    Evidence is bolted on after the fact

    CAPA, audits, design controls, and risk get assembled at inspection time instead of accumulating as you work.

  3. 03

    Enterprise eClinical is priced for pharma

    The validated suites that do this cost more than a startup's entire runway.

How Azora solves it

The studies record and the audit trail, in one place.

The clinical study lives beside the same regulated eQMS hubs as full QMS — plus the AI lineage and a copilot grounded in the trial's own data.

  1. 01

    Studies & study workspace

    The clinical study record plus a study→milestone workspace to run the trial day to day.

  2. 02

    AI lineage registry

    Dataset → model → outcome lineage captured as first-class records — the provenance an auditor will ask for.

  3. 03

    Trial copilot

    Grounded Q&A over the trial's own data — answers that cite the record, not the open internet.

  4. 04

    Regulated eQMS evidence

    CAPA/NCR, audits, design controls, risk, change control, and complaints/vigilance — the same audit-ready hubs as full QMS.

  5. 05

    Document & training control

    Controlled documents and per-person training records, versioned and review-tracked.

  6. 06

    Management review & insights

    The governance layer and computed insights that keep the study inspection-ready as it runs.

Practitioner perspective

We needed the evidence chain of a validated eQMS with the speed of an AI team. Building the study and the audit trail in the same place is the only way that math works.
PriyaClinical Program Lead at Azora Optical Solutions · the team that built Azora
dataset→outcomeAI lineage captured as records
1 DBStudy plus regulated evidence
Audit-readyThe same eQMS hubs as full QMS

Connected by design

Clinical R&D does not become another silo.

Azora keeps project, quality, operations, people, clinical, and customer context on one operational data layer. Teams can follow the record instead of rebuilding its history in the next tool.

01

Capture the source

Keep the originating task, study, customer, unit, or people record attached to the work it creates.

02

Govern the handoff

Route ownership and approvals through role-aware workflows, with controlled history where the record requires it.

03

Read the same signal

Let downstream teams and leadership work from linked operational data instead of reconciling exports.

See the connected workflow

Run AI-driven trials that stay inspection-ready.

Explore the live demo, or talk to us about a seeded clinical tenant. Trial and demo data are synthetic only.

Browse all nine solutions →