Integrated Risk-Based Quality Management (RBQM)
By 2026, RBQM has evolved from a standalone "point solution" to an integrated feature of the elluminate platform. This module allows trial sponsors to move away from 100% source data verification (SDV) to a more efficient, targeted monitoring approach.
The platform tracks Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) at the site, country, and study levels. Using predictive modeling, the system can identify "at-risk" sites—those with unusually high screen failures or suspiciously low adverse event reporting—before they compromise the study’s integrity. In 2026, this integration allows for bi-directional communication; a risk identified in the RBQM module can automatically trigger a targeted data review task in Data Central, ensuring that the highest risks receive the most immediate attention.