Cambridge – – October 14, 2026 -- TRI has released OPRA 26.2, an update to its risk-based quality management (RBQM) platform that adds an AI agent, RiskIQ, to draft protocol risk assessments. The release is available from October 14, 2026.
RiskIQ drafts Critical-to-Quality assessments from uploaded protocols
RiskIQ sits in OPRA's Protocol Insights module. It analyzes an uploaded protocol and generates a first-draft assessment of Critical-to-Quality (CtQ) factors, risks and their relationships. It works from each organization's own CtQ types and risk categories rather than generic templates.
Risk managers can edit, accept or reject every suggestion before promoting the result into OPRA as the initial risk assessment. No AI-generated content enters a live study automatically. Every decision is audit-logged and exportable.
RiskIQ is also available as a standalone application that works with any RBQM platform.
Risks now link directly to Centralized Monitoring controls
Each risk is tied to the Centralized Monitoring controls used to manage it, so risk owners can see when performance falls outside tolerance. Review-driven actions keep a link to the evidence behind them. Controls Automation creates routine observations automatically.
Cross-functional review moves out of spreadsheets and into the platform
Risk managers can invite colleagues to review and comment on CtQs, risks and AI suggestions inside OPRA while keeping ownership of the final assessment.
Organizations can define their own subject data review types
Teams can set up review types such as safety, eligibility or endpoint reviews and specify the data each covers. Change logs show reviewers what has changed since their last review. Every review is tracked and summarized, so medical monitors and clinical research associates can resume where they left off and demonstrate compliance.