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Operationalizing RBQM

through experience and expertise

The 2023 ACRO survey of over 6,000 clinical trials showed that operationalizing RBQM is an industry-wide challenge.


While over 97% of new studies conduct an initial risk assessment, and conduct ongoing risk evaluations, less than 50% have Key Risk Indicators (KRIs) related to data quality or patient safety, and only 42% have centralized monitoring. That demonstrates the size of the problem in moving from the risk assessment to implementing other RBQM components.


We can help with that. From the experience of implementing RBQM solutions on hundreds of trials, we've developed a set of consultancy services and tools to accelerate your RBQM initiatives.

Change Management
Risk-Based Quality Management Change Management

Resistance to change is often cited as the biggest blocker to RBQM success. So, how do you take hearts and minds with you on your RBQM journey? Simple. With our proven 4-step model. Proven because we've used it to drive significant change in global organizations, with lasting results including increased revenues, more efficient trials, and happier staff.

Consultancy & Support
Integrated Strategic Monitoring Plans

ISMPs are the critical link between your Protocol Risk Assessment and successful Central, Remote and Site Monitoring. Get in touch to 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
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
Gap Analysis

Our 6-step process identifies the gaps in your current documentation, tools and processes. The impact analysis highlights priorities for compliance. We then make recommendations for change, giving you a very clear plan for implementing RBQM.

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Compliance Pack
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A suite of documents and templates ready to customize for your organization, including SOPs (e.g. Risk Assessment & Management; and Clinical Quality Oversight), templates (e.g. Integrated Data Monitoring Plan), and job specifications (e.g. Central Monitor).

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