AOVO Uses Governed AI to Secure Clinical Data Workflows and Automate Audit Trails

AOVO, a private nephrology research facility on the Gold Coast, is using governed AI for clinical trials to search complex documents, automate audit trails, and support regulated clinical workflows.

The facility says ORCA Opti Assist has reduced core clinical trial workflows from 45 minutes to under five. A single morning’s billing review also surfaced tens of thousands of dollars in unclaimed items.

The technology gives staff answers from clinical trial documents while showing the source passage alongside each response. This traceability matters because AOVO works across multiple studies where every decision must link back to source material.

AOVO works with commercial sponsors and investigators across several studies at once. These include Phase 1-3 multi-centre programmes.

Each trial has its own protocol, lab manual and pharmacy manual. Those documents can each run to hundreds of pages. Finding a specific answer therefore requires staff to search and cross-reference documents. In some cases, they must wait for a response before acting.

The same issue affects patient visits. Staff may need to search documents in real time to answer a patient question. Evaluating a new trial opportunity can also consume significant staff time.

At the same time, AOVO must meet GCP, TGA, Privacy Act, and ICH standards. Every answer needs a source, while every decision needs a trail. Maintaining that record manually became harder as the research portfolio grew.

Governed AI for Clinical Trials Cuts Document Search Times

AOVO first saw ORCA Opti in 2025. Operations Manager Yupin Robson identified search as one of the site’s major bottlenecks.

After planning and demonstrations, AOVO began a three-month trial in mid-2026. The initial goal was to help staff get accurate, auditable answers more quickly.

The site loaded three active trials into ORCA Opti Assist. For each trial, it added the protocol, lab manual, and pharmacy manual.

Coordinators, pharmacists, lab staff and the investigator could then query the documents using plain language. ORCA returned answers drawn from the source material and displayed the exact passage alongside each response.

According to AOVO, the results included:

• Answering a patient question during a visit reduced from approximately 30 minutes to approximately two minutes
• Working through a procedural scenario reduced from approximately 45 minutes to approximately two minutes
• Evaluating a new trial opportunity reduced from approximately 60 minutes to approximately five minutes

“That time saving is a really difficult one to answer, because it’s not just an hour. You’re talking about very precious real estate in everyone’s day. And if it saves me 5 minutes, what that 5 minutes possibly could mean is a week’s worth of decisions that get made in that 5 minutes,” said Robson.

ORCA also logged every query, answer, and source reference automatically. According to AOVO, this provided an audit trail for GCP documentation requirements that previously required manual effort.

By the end of the trial, AOVO considered the initial information retrieval problem addressed.

“I feel like we’ve fixed the information for the coordinator. That’s nailed,” said Robson.

AOVO converted from trial to a paying customer.

Billing Review Surfaces Tens of Thousands of Dollars in Unclaimed Items

The next use case was not part of the original roadmap. Robson identified it while working with clinical trial billing.

Each clinical trial has its own contract and payment terms. Reconciling completed work against submitted claims can therefore involve slow and manual reviews.

Robson loaded a trial’s invoicing material into a Knowledge Pack. She then asked ORCA to reconcile what had been billed, what remained outstanding, and what was missing.

The review took a morning. According to AOVO, it surfaced tens of thousands of dollars in unclaimed and misrecorded items on that trial alone.

One discrepancy involved an assumption that applied to every other study at the site, but not this one. ORCA identified the difference, which represented $6,500 in reimbursements that had never been claimed.

AOVO submitted the invoice immediately, and it is now in the system for payment.

The review also identified incorrectly recorded items that were blocking claims. Once staff found those issues, they could correct them.

“Me using ORCA to audit in the finance world has just saved so much time and actually so much confusion,” said Robson.

AOVO Expands AI Across Clinical Operations and Compliance

AOVO and ORCA are now moving beyond information retrieval. They are working towards automating more of the clinic’s operational processes while mapping that work to compliance obligations.

The goal is to make work more consistent and reduce the time required across studies. Mapping those activities to regulatory obligations can also create evidence of how the work was completed.

In this model, compliance records become part of the workflow rather than a separate manual task.

Areas in development include:

• Screening support, using existing clinical correspondence to surface potential trial participants who might otherwise be missed
• Milestone and payment tracking, reducing the manual overhead in the invoicing cycle
• Compliance cross-referencing, so that TGA, ICH, GCP and Privacy Act requirements sit alongside protocol answers rather than in a separate workstream
• A glomerulonephritis patient registry, with risk stratification, a clinician review interface and an append-only audit trail

The proposed registry targets a persistent challenge in nephrology research: identifying and retaining patients with low-prevalence conditions across a fragmented clinical landscape.

“If you actually pack the problem up, what is the actual problem that you’re solving? You’re solving the ability to wade through big data very quickly. So the use case is all these different examples, but the problem you’re solving is actually getting through the data,” said Robson.

Kat Giudes, Founder and Managing Director of ORCA Opti said: “AOVO is the whole idea in one place: connect the documents, get answers in seconds with the source attached, and the audit trail writes itself. No migration, no IT project, just precious clinical time handed back to the team.”

For more information about ORCA Opti, click here.

About ORCA Opti

ORCA Opti is the governed AI and compliance platform built for regulated organisations. Founded in 2024 and headquartered in Brisbane, ORCA Opti runs inside Microsoft 365 on sovereign infrastructure, giving teams a safe way to operationalise AI while continuously measuring compliance posture against the standards their industry runs on.