The deployment follows a three‑month pilot in which AOVO uploaded protocols, laboratory manuals and pharmacy manuals from three active studies into the Orca Opti Assist platform. Staff—including coordinators, pharmacists, lab technicians and the principal investigator—were then able to pose plain‑language queries and receive answers that were automatically linked to the exact source passage.
According to the company, the time savings are dramatic: a patient question that previously required about 30 minutes to resolve now takes roughly two minutes; a procedural workflow that once ran for 45 minutes can be completed in about two minutes; and the assessment of a new trial opportunity has dropped from an hour to five minutes.
Operations manager Yupin Robson said the system also generates an audit trail for every query, answer and source reference, eliminating the manual effort previously needed to satisfy Good Clinical Practice, Therapeutic Goods Administration, Privacy Act and International Council for Harmonisation compliance requirements.
After the successful trial, AOVO became a paying customer and expanded the tool’s use to billing reconciliation. By loading invoicing documents from one study into a knowledge pack, the software identified tens of thousands of Australian dollars in unclaimed or mis‑recorded items, including a single discrepancy of AUD 6,500 that had been missed due to an erroneous assumption about contract terms.
Robson noted that the finance‑focused audit saved both time and confusion, allowing the erroneous invoice to be corrected and submitted immediately. The organisation is now exploring further applications such as screening potential trial participants, tracking study milestones and payments, and building a glomerulonephritis patient registry with risk stratification and an immutable audit trail.
Orca Opti, based in Brisbane, said its software is already used by regulated Australian organisations. Founder and managing director Kat Giudes described the AOVO deployment as “the whole idea in one place: connect the documents, get answers in seconds with the source attached, and the audit trail writes itself,” adding that the solution requires no migration or extensive IT projects.
The adoption highlights a growing trend among clinical research sites to leverage AI‑driven knowledge management tools to reduce manual document review while maintaining the traceability essential for regulatory compliance.