Subject Profiles – Review and monitor subject data with ease At the core of every study are the subjects - patients and healthy volunteers who willingly participate in a trial. As clinical researchers, [...]
Synergy of QbD, RBM, and RBQM in Trials
Clinical trials require a comprehensive approach to ensure quality and efficiency. Quality by Design, Risk-Based Monitoring, and Risk-Based Quality Management work together to achieve these goals, focusing on building quality into the trial process, targeting monitoring activities, and continuously improving trial quality.
Patient Safety in Clinical Trials
What is the future of patient safety in clinical trials? The life sciences industry is experiencing an evolution. Technology is forcing digital transformation and is rapidly changing the way that companies conduct research, test [...]
Why the Industry Finds It Easier to Embrace Key Risk Indicators than Quality Tolerance Limits
This opinion piece by Keith Dorricott, MBB, addresses the challenges faced by the clinical trial industry in implementing QTLs and KRIs as required by ICH E6(R2). The article explores why KRIs have been easier to adopt than QTLs and wonders if the specific guidance provided by ICH E6(R2) is partly responsible.