Causing a Wave of New Career Opportunities
Clinical research is in the grips of a revolution that has caused a wave of new career opportunities.
Achieving Successful Decentralized Trials by Leveraging RBQM and Centralized Monitoring Oversight
Virtual or decentralized clinical trials present a far more patient-centric approach to conducting clinical research, building convenience and flexibility into the process, and allowing participants to engage in trials from the comfort of their day-to-day environment.
Detection of Fraud in a Clinical Trial Using Unsupervised Statistical Monitoring
A central statistical assessment of the quality of data collected in clinical trials can improve the quality and efficiency of sponsor oversight of clinical investigations.
Unlocking the Potential of Risk-Based Quality Monitoring
Risk-Based Quality Management (RBQM) and Risk-Based Monitoring (RBM) are shifting the clinical research landscape, dramatically accelerating the drug development pathway, driving data quality, and ensuring early risk detection.
Why Risk-Based Quality Management Represents the Future of Clinical Research
By empowering researchers to detect data quality issues in real-time, Risk-Based Quality Management (RBQM) and Risk-Based Monitoring (RBM) have proven their value during the race for a COVID-19 vaccine in which trials required the processing of huge volumes of data from dozens of global sites.
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.
