Mar2023

Subject Profiles

March 20, 2023|Comments Off on Subject Profiles

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, [...]

Mar2023

Synergy of QbD, RBM, and RBQM in Trials

March 20, 2023|Comments Off on 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.

Mar2023

Patient Safety in Clinical Trials

March 14, 2023|Comments Off on 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 [...]

Mar2023

Why the Industry Finds It Easier to Embrace Key Risk Indicators than Quality Tolerance Limits

March 14, 2023|Comments Off on 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.