OPRA Risk Assessment & Management

Smarter Risk Management for Clinical Trials

Reduce uncertainty and inefficiency by transforming how your team manages risk. Our approach helps sponsors and CROs prioritize critical issues, centralize oversight, and keep trials on track, delivering compliance and confidence across every phase.

Confident, Stronger compliance.

Focus on What Matters

Manage and prioritise risks in one platform, identify urgent issues instantly, and keep full visibility over trends and ownership.

Confidence in Compliance

Build clear risk relationships, monitor controls across studies, and stay audit-ready with proactive, transparent compliance.

Efficiency from Setup to Submission

Simplify study start-up, maintain consistent oversight, and save time with automated alerts and activity tracking.

Oversight That Drives Action

Track risks in real time, assign accountability for quick resolution, and use data insights to strengthen trial integrity.

Key Features of OPRA-RAM

Risk Library

Capture enterprise knowledge and ensure consistency with standardised libraries. Categorise risks by phase, design, or therapy area.

Risk Dashboard

Visualise changes in risk profiles over time. Track categorisation, overdue actions, and upcoming tasks, all in one screen.

Central Activity Management

Assign risk owners, monitor root causes, and track completion dates in a single portal. Full-cycle visibility, simplified.

One-Click Reports

Generate formatted, visual PDF reports in seconds. Export on-demand or store in-system for portfolio-level oversight.

Why OPRA RAM?

Real-time insights

Availability of up-to-date risk scores

Document corrective actions

Document key information

Collaboration

Centralized portal to collaborate with stakeholders

Trend analysis

View evolution of risks over time

Alerts

Customizable alerts

Data visualizations

Customizable data visualizations

Version Control

Eradicates duplication

Audit ready

Full discoverability of mitigations after closeout

Why Choose TRI?

Trusted

Dependable software. Genuine trust. TRI delivers, on time, at scale, with clarity.

Responsive

In a rigid industry, we’re the human touch: pragmatic, responsive, and known by name.

Innovative

We lead, not follow. TRI is fast-moving and data-informed, staying ahead of Sponsor and CRO needs.

RBQM Success Stories

"Worldwide’s RBQM team is one of the most experienced CRO teams in the industry. This, coupled with TRI’s best-in-class technology, ensures we can proactively identify and manage risks, meaning improved quality and patient safety, and, in turn, provide a better experience for sponsors and patients."

"What truly set TRI apart from other vendors was their unparalleled commitment to a quality deliverable helping us effectively apply a novel approach to our operations. They achieved a deep understanding of our objectives by partnering with us on a rigorous change management process which culminated in a shared vision for the integration of their risk assessment and central monitoring solution."

"The Worldwide Clinical Trials team is pleased with our continued partnership with TRI and we are excited about the milestone of having 150 clinical trials in TRI's Risk-Based Quality Management platform. This is a key benefit for our customers as it improves data quality, trial efficiency, and patient safety."

"It has been such a wonderful ride with our TRI partners over the last few years developing our RBQM strategy with our Sponsors and Worldwide Clinical Trials Teams! We love working with everyone at TRI and look forward to bigger and better things to come!"