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Everything you need to
implement RBQM in your organization

Consultancy and 

support services

Implementing RBQM isn't easy because it impacts every part of your organization.

Pick a partner who understands the challenges you face because they've successfully done it before.


Consultancy & Support

Advice from operational experts on everything


Protocol Risk Assessments


Integrated Strategic Monitoring Plans

Central Monitoring

Access to specialist skills in setting up and using CM tools and features.

Key Risk Indicators,

Key Performance Indicators


Quality Tolerance Limits


Change is hard. Get help from highly experienced and skilled people.


Project Management


Effective Communications.

Protocol Risk Assessments

Good Protocol Risk Assessments are fundamental for high quality clinical trials. Correctly identifying critical variables up front, creating risk statements and then evaluating likelihood, impact and detectability are all vital skills.

TRI team working with sponsor and CRO clients on RBQM RBM Clinical Trial Study Protocol Risk Assessment ICH E6 (R2) Risk Based Monitoring Risk-Based Quality Management
Integrated Strategic Monitoring Plans

ISMPs are the critical link between your Protocol Risk Assessment and successful Central, Remote and Site Monitoring. Find out how they work and the 10 key elements to making cross-functional ISMPs effective and efficient. 

TRI Team working with sponsor and CRO on ICH E6 (R2) RBQM RBM Integated Strategic Monitoring Plan for Clinical Trial Study Risk Based Monitoring Risk-Based Quality Management
CM tools and features

KRIs, KPIs and QTLs are all very powerful tools in Central Monitoring...if they are set up and used correctly. Get expert advice on which ones to use, when and why. Pick from the extensive libraries built into OPRA 5 or create new ones specifically tailored for your study.

RBQM RBM ICH E6 (R2) E8 OPRA software platform dashboard for centralized central monitoring for remote and site reporting on clinical trial study Risk Based Monitoring Risk-Based Quality Management
Change Management
Change Managment implement RBQM RBM ICH E6 (R2) E8 Risk Based Monitoring Risk-Based Quality Management

Change is hard in every organisation. Resistance to change is a natural human reaction. To overcome it you need a compelling reason to change, a strong vision for the future, a solid plan to get there, and clear and open communication with everyone affected. We can help because we've successfully done it before for Sponsors and CROs.


Implementing RBQM

ICH E6 (R2) Quality Management Process RBQM Risk-Based Quality Management RBM Risk Based Monitoring

Our services, combined with OPRA 5 and our e-learning packages, are specifically designed to deliver each of the seven risk-based approaches set out in ICH E6 (R2) Quality Management Section 5.0.

According to our customers, our approach is different to other technology vendors in the sector. We know that technology will fail if the right processes aren't in place, and people can't or won't use them.


We know every organization is unique, each culture is different and everyone is facing their own specific challenges. That's why we take the following approach to every one of our customer engagements:

  • People 1st
  • Process 2nd
  • Technology 3rd

To find out how we can help you and your set of challenges, fill in the form below.