TRI Introduces AI-driven Risk Assessment and Connected Oversight in Latest OPRA Release

CAMBRIDGE, England, Oct. 14, 2026 /PRNewswire/ -- TRI has announced the latest release of OPRA, its risk-based quality management (RBQM) platform. The release introduces a connected approach to RBQM that takes teams from protocol analysis to live oversight without breaking the chain of evidence between them.

As clinical research moves towards more proportionate, risk-based quality management, teams need more than a static risk assessment. They need to know which risks matter, how they are being controlled and what happened when a signal required attention. OPRA 26.2 brings that context into one platform.

AI that provides a faster, more relevant starting point

RiskIQ, a new AI agent in OPRA's Protocol Insights module, analyzes an uploaded protocol and generates a first-draft assessment of Critical-to-Quality factors, risks and their relationships. It uses each organization's own CtQ types and risk categories, helping teams move beyond generic templates.

Risk managers can edit, accept or reject every suggestion before promoting the result into OPRA as their initial risk assessment. No AI-generated content enters a live study automatically, and every decision is audit-logged and exportable.

RiskIQ is also available as a standalone application that can be used with any RBQM platform

From identified risk to measurable control

OPRA 26.2 turns the risk assessment into an active part of study oversight. Each risk links to the Centralized Monitoring controls used to manage it, so risk owners can see when performance falls outside tolerance. Review-driven actions retain a clear link to the evidence behind them, while Controls Automation creates routine observations automatically.

Collaboration with accountability built in

Risk managers can invite cross-functional colleagues to review and comment on CtQs, risks and suggestions in OPRA, whilst retaining ownership of the final assessment. Teams no longer need to take the process offline into spreadsheets.

Focused subject data review

Organizations can now define their own review types, such as safety, eligibility or endpoint reviews, and specify the data each one covers. Change logs show reviewers exactly what has changed since their last review. Every review is tracked and summarized, so medical monitors and CRAs can pick up where they left off and demonstrate compliance.OPRA 26.2 is available from 14^th October 2026.  Learn more at www.tritrials.com.

About TRI

TRI has spent 13 years helping sponsors and CROs deliver better-quality clinical trials through Risk-Based Quality Management. More than 450 global clinical trials have run on OPRA, TRI's RBQM platform, and more than half of TRI's people have worked at a sponsor or a CRO before joining. That experience shapes everything TRI builds