Part of the elluminate Clinical Data Cloud, elluminate RBQM provides clinical teams with a single platform for all study data sources for a more focused risk monitoring effort that enables better trial oversight and ensures trials compliance. elluminate RBQM supports greater trial efficiency, ensures patient safety, and provides the flexibility to adapt and scale with evolving challenges.
The effectiveness of RBQM relies heavily on the integration of diverse data sources, and taking a platform approach to risk management provides a single source of truth for all trial data – eliminating data silos and the need to access multiple applications for high quality data.
Adopting RBQM is not only driven by regulatory guidance (ICH E6 R2), but also essential to ensuring patient safety and achieving operational efficiency. elluminate RBQM offers a broad set of capabilities enabling sponsors to integrate risk-based strategies as well as a phased implementation approach to reduce adoption challenges, allowing trials of all sizes to benefit from RBQM while ensuring regulatory compliance.
In collaboration with SCDM, we discuss the case for elevating risk-based approaches …
RBM is a strategy that uses technology, data & analytics to monitor risk and support decision-making & trial management. RBQM is a more expansive, end to end process that involves focusing on factors critical to quality and patient safety. It’s a systematic process put in place to identify, assess, control, and review risks throughout the entirety of the trial lifecycle. Our overview of elluminate RBQM further elaborates on the benefits of Risk-based Quality Management.
Yes, ICH E6 (R2) states that sponsors should develop a risk-based approach to monitoring trials and articulates sponsor oversight requirements. Additionally, guidance documents have been released by TransCelerate Biopharma to help drive adoption.
RBQM is part of the elluminate Clinical Data Cloud which provides real-time integration and standardization capabilities for all trial data types and formats, creating a single source of truth for all trial data, unlike other RBQM offerings, elluminate RBQM is the only offering within a platform with access to a Clinical Data Repository (CDR) and Operational Data Repository (ODR). With the platform approach, analytics silos are removed and the need to access multiple applications for high-quality data is eliminated. The holistic view of risk across data sources provides better visibility into the status of the study for all stakeholders and built-in issue integration creates a seamless workflow between data management and central monitoring teams. For further insight, consider viewing our elluminate RBQM overview.
Typically, a combination of Clinical Operations and Central Monitoring teams are the primary users however, additional roles may find RBQM useful. Data managers can use it for risk-based data review and site monitors can utilize this to better understand performance at their assigned locations. Additionally, a platform approach like elluminate RBQM serves as an advanced data management workbench for data management and data science teams for tiered data review and greater cross-function collaboration.
Yes, elluminate RBQM can play a very important role in an outsourced model. Beyond assessment, identification, and overview of risk at sites, elluminate RBQM ensures efficient CRO oversight using a risk-based approach.
Yes, we have chosen to implement the Transcelerate framework for out-of-the-box capabilities, facilitating quicker time to value. However, other risk assessment frameworks can be used.
Yes, elluminate RBQM provides the ability to configure KRIs with the option to run CSM methods on the KRIs, allowing users to identify and detect systematic data errors, anomalies, and fraud at the site level. CSM results are displayed within RBQM and allow users to investigate any sites that are outside the CSM alpha value threshold.
