A Robust Risk-Based Quality Management Framework

FDA has placed ICH E6 (R2)—a revision to Good Clinical Practice (GCP)—in the federal registry. ICH E6 (R2) makes explicit the responsibility of the Sponsor to understand and actively manage the risks to quality in clinical trials using a Quality Risk Management (QRM) approach.

While GCP now requires that Sponsors (or CRO delegates) implement quality risk management of clinical trials, many companies are still working on becoming compliant. At Rho, we have implemented a robust Risk-based Quality Management (RBQM) Framework, including:

• Dedicated Risk-based Quality Managers to guide you through the QRM process
• Expertise with RBQM across all functional areas
• RBQM templates, including Integrated Quality Risk Management and Central Monitoring Plans
• RBQM requirements built into our standard operating procedures (SOPs)
• Strategic approach to data review and trend identification
• Industry-leading cloud-based risk-based monitoring platform

RBQM is the foundation required for decentralized and virtual clinical trials, as well as for a targeted, risk-based approach to monitoring, which can include risk-based monitoring, central monitoring, off-site monitoring and targeted site data verification (tSDV). With a focus on your trial’s most critical risks, you can choose a monitoring strategy that provides the most value rather than the most time on-site.

Using our robust RBQM framework, our project teams will help you determine the level of decentralization your clinical trial might require, as well as the risk-based monitoring strategies that are right for your trial. These could include:

• Central monitoring – remote assessment of study level Key Risk Indicators (KRIs) and other sources
• Off-site monitoring – remove assessment of site-level issues, data and site performance
• On-site monitoring – on-site assessment of site quality via SDR/SDV/tSDV and investigational site GCP assessment

In a quality-driven, risk-based approach to clinical monitoring, the schedule of visits relies on the judgement of the study management team and access to the risk control measurements. This streamlined approach to the clinical trial monitoring process can reduce the burden of on-site visits for the sites, as well as the overall monitoring budget, while not sacrificing the quality of the data.