Risk-based Quality Management Services (RBQM)

An evolved risk based quality management strategy to stay ahead of clinical development data challenges

A holistic operational risk-based monitoring system isn’t just a good idea; it’s an essential requirement of today’s high functioning clinical trial ecosystem. Ever-increasing trial complexity, expanded data sources, surging data volumes and a host of new delivery models require fundamentally different approaches to how we collect and manage clinical trial data.

Parexel’s RBQM approach helps clients identify, capture, and manage data quality issues at the earliest stages of emergence before potential risks escalate into liabilities. This risk-based monitoring approach forms the basis of a fit-for-purpose monitoring strategy, using study risk assessments, complexity, country requirements, site monitoring and capabilities as key considerations. A continuum of models includes:

• Central monitoring
• Remote monitoring variations
• Traditional onsite monitoring 

Advanced Analytics

Parexel leverages historical data across hundreds of trials to model predictive scenarios and categorize risk by severity of impact. AI techniques complement clinical development and therapeutic knowledge to offer an unprecedented level of sensitivity when characterizing trends of importance or potential compliance issues.

• Preventable quality issues can be avoided with agile decision-making based on real-time, centralized data
• Known and unknown risks can be rapidly detected on both critical and non-critical data, reducing ‘noise’ by filtering out less relevant data
• Monitoring resources can be prioritized on data insights rather than the traditional 100% Source Data Verification (SDV) approach

Scores of well-established benefits related to risk based quality management adoption include:

• 4x lower error rate in critical data in a head-to-head comparison of RBQM to traditional 100% SDV approach¹
• Up to 40% faster database lock timelines compared to non-RBQM trials¹
• 20% reduction in SDV1¹
• 45% reduction in the number of missing pages in RBQM trials vs non-RBQM trials¹

[1] Association of Clinical Research Organizations. Accessible at https://www.acrohealth.org/wp-content/uploads/2019/10/EDL_ACRO_Graphics_CO3.pdf