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

Explore key information about TRI

Choosing the right oversight partner demands precision and clarity. We tackle your most common questions head-on, equipping you with the insights you need to make confident, informed decisions.

Can your system record user comments queries or answers?

Yes. The system includes a built-in management tool called the Central Monitoring Toolkit. It lets users record comments and actions related to the study, a site, or the data in charts and tables. You can update this information any time. You can also view it in standard reports or export it to Excel.

Can your system assign comments, queries, or answers to specific users?

Yes. You can assign observations and actions to individual users, tams or both. The system also alerts users when it assigns new actions to them.

Can your system detect trends, outliers, or unusual data automatically?

Yes. The platform uses tailored data charts and statistical models for each clinical trial. These tools help spot patterns, trends and data issues. The systems design makes it easy to view and act on these insights.

Can users drill down from study date to site, subject, and visit-level details?

Yes. Each KRI or KPI on the Study Hub lets you click through to more detailed data. You can filter this view to focus on subjects, visits, assessments, or even specific data points. This drill-down feature is key for strong centralized monitoring and risk based quality management.

How does your system meet regulatory guidelines like ICH E6 R3?

OPRA supports all key RBQM processes for clinical trials, as defined in ICH E6 R3 and earlier guidelines. It enables sponsors and CROs to effectively manage quality and risk throughout the entire clinical trial lifecycle.

TRI works closely with leading groups like ACRO, PHUSE, and TransCelerate. We also learn from our user community and apply best practices in each platform update.

What risk indicators (KRIs, QTLs, etc.) does your system support? Can we customize them?

Yes. The system supports any number or type of KRIs, KPIs and QTLs. We offer a standard set to start with, and you can customize it based on your study or therapy area.

You can also create new data charts and indicators as needed. This makes the system flexible and effective for any risk assessment approach or RBQM for clinical trials.

What support do you provide for onboarding and ongoing training?

We assign a full implementation team to each client. Support includes:

Templates to simplify setup

A sandbox area to test and review configurations

A walkthrough of your custom setup

We also train your system admins and super users. Online training videos are available before and after launch. Soon, we’ll add a support hub within the OPRA app for easy access to help content.

Do you require confidentiality or NDA agreements for staff and vendors?

Yes. We take data protection seriously. All TRI employees, contractors and partners must sign confidentiality or non-disclosure agreements before gaining system or data access.

How long have you provided centralized monitoring for clinical trials?

TRI has delivered clinical trial tools since 2013. We launched our Centralized Monitoring service in 2016 and added our Risk Assessment and Management module in 2020.

Do you have experience with oncology trials?

Yes. OPRA works well with oncology studies because of their complexity and large data volume. Around 30% of our work has been in oncology.

Can your system adjust to changes in study protocols?

Yes. The system handles changes. During setup, we include a wide range of Key Risk Indicators that give flexibility as the trial evolves. This makes it easier to manage modern complex clinical trials with strong risk-based quality management.

If you have further questions or want to chat with a member of our team, feel free to reach out to us directly.

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!"