From RBM to RBx: The Keys to Successful Adoption and Implementation
The latest version of the Good Clinical Practice (GCP) quality standard insists that sponsors implement a risk-based approach to study execution, a methodology that is now widely referred to as “RBx.”
Detection of Atypical Data in Multicenter Clinical Trials Using Unsupervised Statistical Monitoring
A risk-based approach to clinical research may include a central statistical assessment of data quality.
Leveraging Intelligent Analytics to Realize the Full Value of RBx and Compliance with ICH E6 (R2)
Not only is there a significant good clinical practice (GCP) expectation, Risk-Based Monitoring (RBM) presents a tremendous opportunity for organizations to drive higher quality study outcomes, shorter study timelines, and all at a lower cost of development.
FDA Offers Further RBM Guidance Stressing Data Quality Oversight
Since finalizing its risk-based monitoring guidance in 2013, the FDA is providing additional information in a new Q&A that reinforces the importance of performing risk assessments for all studies.
How SMEs Can Achieve Regulatory Compliance Through a Risk-Based Approach
Since the introduction of the ICH E6 (R2) addendum, the industry has seen a rise in the implementation of a variety of risk-based monitoring (RBM) methodologies and technologies.
Update on ICH E6 (R2) Guideline for GCP
The ICH E6 R2 Addendum is starting to have a significant, positive impact on clinical trial design – offering a real opportunity to inject efficiencies into clinical research and development.
A Revolutionary Cure for RBM and Centralized Monitoring
In the clinical trials industry there is a tendency to watch and wait, which has been the case with RBM.
