Risk Management

Made Simple

Discover a simpler way to manage clinical trial risk. OPRA-RAM is a user-friendly platform that centralizes risk assessment and management so teams can quickly identify, track, and mitigate study risks.

ABOUT OPRA RAM

Risk management, simplified

OPRA-RAM transforms risk assessment and management by consolidating all activities into a single platform. Designed for ease of use, it allows teams to quickly prioritize risks, implement controls, and maintain oversight with confidence. By centralizing processes and promoting proactive risk management, OPRA-RAM ensures that studies stay on track and compliant.

  • Focus
  • Confidence
  • Efficiency
Clinical Trial Risk Management
Focus

Stay ahead of study risks

Cut through complexity to stay focused on what matters. OPRA-RAM centralizes risk assessment and management, replacing outdated, manual processes with a streamlined, intuitive system. By bringing all risks, controls, and actions into one place, teams quickly prioritize critical risks, assign ownership, and track trends to maintain oversight and take proactive action.

  • Manage all risks, controls, and actions in one place
  • Easily score and prioritize critical risks
  • Quickly identify key areas of focus
Confidence

Ensure compliance and control

Outdated systems make it difficult to demonstrate that risk management is being carried out effectively. OPRA-RAM ensures compliance with a validated, centralized system that applies standardized risk libraries and best practices. By tracking trends and maintaining clear risk-variable relationships, teams can be confident that risks are well-managed and documented.

  • Establish clear risk-variable relationships
  • Track trends over time
  • Demonstrate proactive risk management
Efficiency

Efficiency without complexity

With limited resources and growing oversight responsibilities, teams need a smarter way to manage risk. OPRA-RAM streamlines risk assessment and management, accelerating setup and keeping studies on track through a central, easy-to-use portal. Centralized actions, reusable risk libraries, and automated alerts reduce manual effort—so teams can focus attention where it is needed most.

  • Create risk libraries to streamline setup
  • Centralize activity management
  • Quickly prioritize risk and implement controls

Compare

Clinical Trial Risk Management Strategies

Spreadsheets
Data Visualization Tools
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

Document corrective actions

Document key information 

Assign actions

Assign actions to stakeholders

Audit ready

Full discoverability of mitigations after closeout

FAQs

We've got the answer

Explore our FAQs for answers and expert advice on RBQM.

Yes, you can try us for free for 30 days. If you want, we'll provide you with a free 30-minute onboarding call to get you up and running.
Of course you can! Our pricing scales with your company. Chat to our friendly team to find a solution that works for you as you grow.
Of course you can! Our pricing scales with your company. Chat to our friendly team to find a solution that works for you as you grow.
Yes, you can try us for free for 30 days. If you want, we'll provide you with a free 30-minute onboarding call to get you up and running.
Of course you can! Our pricing scales with your company. Chat to our friendly team to find a solution that works for you as you grow.
Of course you can! Our pricing scales with your company. Chat to our friendly team to find a solution that works for you as you grow.
TESTIMONIALS

RBQM Success Stories

Hear directly from our partners about how we've helped them.

Peter Benton President & CEO, Worldwide

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.

Jeff Smith Former CEO, Alimentiv

What truly set TriTrials 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.

Amandeep Sonik Senior Director, RBQM, Worldwide

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.

Kelly Parish Holladay AD, RBQM, Worldwide

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!

RBQM NEWS

Clinical trial quality news and views

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The Quality Issue – January 2025

The Quality Issue – January 2025

Happy New Year, and welcome to our first Quality Issue of 2025! It this edition, we spotlight some of the most important developments in clinical research and Risk-Based Quality Management…

Dose Optimization in Oncology: Advancing Clinical Trial Quality through Risk-Based Approaches

Dose Optimization in Oncology: Advancing Clinical Trial Quality through Risk-Based Approaches

The complexities of oncology drug development have long posed significant challenges, particularly in determining the optimal dose that balances therapeutic efficacy with patient safety. The FDA’s recent guidance on dose…

TRI Joins Veeva’s Product Partner Program

TRI Joins Veeva’s Product Partner Program

Partnership will drive quality and efficiency in clinical trials through enhanced risk-based quality management integration. [Cambridge, UK – 17.10.2024] – TRI, a leading Risk-Based Quality Management (RBQM) software provider for…