Part of the elluminate Clinical Data Cloud, elluminate RBQM provides clinical teams with a single AI-powered platform for all study data sources for a more focused risk management and monitoring effort that enables better trial oversight across various functions and ensures trials compliance. elluminate RBQM supports greater trial efficiency, ensures patient safety, and provides the flexibility to adapt and scale with evolving challenges, allowing full planning and execution of Integrated Quality Risk Management.
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 holistic risk based quality management and data monitoring.
Adopting RBQM is not only driven by regulatory guidance (ICH E6 R3, ICH E8 R1, MHRA), but also essential to ensuring operational efficiency. elluminate Risk Management offers a broad set of capabilities enabling sponsors to integrate risk-based strategies as well as a phased implementation approach to reduce adoption challenges, and allowing trials of all sizes and complexity 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 study risks and support decision-making & trial management. RBQM is a more expansive, end to end process that involves focusing on both critical data and processes across entire portfolio. It’s a systematic process put in place to identify, assess, control, and review risks throughout the entirety of the trial lifecycle and across studies and countries. Our overview of elluminate Risk Management further elaborates on the benefits of Risk-based Quality Management.
Yes, there are multiple regulatory guidelines. ICH E6 (R3) states that sponsors should develop a risk-based approach to identify Critical To Quality Factors, prioritize risks and conduct proportionate risk-based monitoring and data review as key quality controls. It also mandates quality oversight to be done on both trial and system level. ICH E8 (R1) highlights the importance of Quality by Design by conducting protocol risk assessment as early as possible in the protocol development lifecycle. MHRA reinforces the importance of engaging cross-functional team in risk related activities.
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, supporting implementation of a strong IQRM strategy. Unlike other RBQM offerings, elluminate RBQM is the only offering within a platform with access to clinical trial data across different personas creating one-stop-shop for all data review need, and provides native AI capabilities for intelligent risk detection. 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, Data Managers, Risk Managers, Clinical Operations and Central Monitoring teams are the primary users however, additional roles may find RBQM useful. Quality managers can use it for risk-based process oversight and site monitors can utilize this to better understand their site performance. 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 with the advancements of the industry best practices evolved in the last 10 years.
Yes, elluminate RBQM provides the ability to configure KRIs with the option to run CSM methods on the KRIs. It also provides broader capabilities to identify data anomalies and cases of the data slopiness utilizing advanced analytics, AI and ML.
eClinical partnered with ZS to provide customers with eClinical’s best in class technology for executing a robust Integrated Quality Risk Management (IQRM) strategy combined with industry leading expertise from ZS in the RBQM space. The partnership will support customers building and seamlessly implementing the best RBQM approaches across a trial portfolio.
