Managing Clinical Trials Amid the Coronavirus Pandemic
Amid the ongoing Coronavirus pandemic, clinical trial sites are increasingly inaccessible for patients and site staff, and as regulators halt inspections, the pharma and biopharma industry faces numerous challenges to ensure patient safety, compliance, and data quality and integrity.
Effective Risk Management When Using eCOA and ePRO
The use of direct source data capture in clinical research is on the rise, both during clinic visits and remotely by patients.
Leveraging Audit Trails to Monitor Clinical Study Risk
The clinical research industry has gone through an important transformation over the past 15 to 20 years, from a largely paper-based paradigm to one in which electronic systems are regularly—and increasingly—leveraged for all aspects of clinical trial planning, execution, and management.
Using Statistics to Improve Data Quality and Maximize Trial Success
Poor quality data has the potential to destroy the validity of a clinical trial, wasting precious time and resources while introducing sizable roadblocks into the drug development pathway.
How ICH E6 (R2) Provides a Win/Win/Win through Risk-Based Study Execution
Participant safety is the clinical trial sector’s top priority – and striving to achieve this laudable aim also makes for more agile, flexible and efficient studies.
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.
