April 4th 2024
A study conducted by the Tufts CSDD in collaboration with CluePoints and PwC revealed that slightly more than half of sponsors and contract research organizations have adopted risk-based quality management approaches.
Technology Implications for the New ICH Addendum
November 8th 2016The ICH is publishing its long-awaited guidelines on how to conduct clinical monitoring in trial management. Sponsors and CROs can integrate existing and emerging technologies while transforming their reactive oversight strategies to an RBM approach using these steps.
Risk-Based Monitoring: What Does it Mean for Clinical Study Sites?
October 14th 2016Risk-based monitoring continues to remain in the spotlight as an accepted and oft implemented approach that is likely to become an industry standard. However, concerns have mounted about the potential impact of these changes on clinical study sites.
Ensure Sites’ Readiness for New Monitoring Initiatives
August 25th 2016Investigational sites’ readiness to support new monitoring initiatives such as risk-based monitoring and centralized monitoring will dictate their success. Here are key aspects that sponsors and CROs should establish with investigational sites while implementing these new initiatives.
Quintiles Adds New Capabilities to RBM Solution
June 16th 2015Quintiles announced the addition of advanced statistical monitoring and predictive analytics capabilities to its risk-based monitoring (RBM) solution. Predictive and Advanced Analytics provide model-based capabilities are fully integrated into the solution and are underpinned by Quintiles Infosario® technology platform. These new capabilities are intended to improve precision in risk identification by better understanding underlying “white noise” from safety trigger processes.
RbM Data Reveals Site Screening Due Diligence Improves Patient Dropout and Retention
March 18th 2015Clinical trial patient retention and dropout continues to be an issue amongst biopharmaceutical sponsors, as patient dropouts minimize the statistical power of clinical trial data, requiring study teams to enroll additional patients.
5 Essential Cornerstones of RbM Technology
February 23rd 2015Often overlooked in early evaluation of RBM are the tools and technologies required for successful implementation. Without the right tools to track and prioritize the shift from traditional monitoring to RBM, successful implementation is doubtful, posing detrimental consequences not only for the monitors, but also the overall trial.