FDA Guidance: A Risk-Based Approach to Monitoring of Clinical Investigations (Q&A) The FDA has published a new guidance document titled "A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry," outlining their expectations for sponsors and clinical investigators regarding [...]
Wondering how the COVID-19 pandemic has impacted clinical trials worldwide? Explore the effects conveniently with our user-friendly data visualizer.
Discover how clinical data management in the US has transformed from data collection to a multi-faceted endeavor, driving breakthroughs in biomedical research, diagnostics, drug development, and vaccines. Learn from leading experts, including our Chief Scientific Officer, about the latest advancements and future prospects in this groundbreaking publication.
Explore the benefits of Cyntegrity's Subject Profiles module, a tool designed for clinical researchers to review and monitor subject data with ease. This innovative solution ensures data privacy, research integrity, and effective risk management in clinical 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.
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 treatments, and evaluate data. To continue this progress, industry experts [...]
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.
Explore clinical trial and enrollment activity across countries with ease. Our new eyesON application visualizes data from ClinicalTrials.gov, helping you gain a deeper understanding.
In clinical trials, managing risks that could impact data quality is crucial for ensuring patient safety, data integrity, and regulatory compliance. While Risk-Based Quality Management (RBQM) and Quality Risk Management (QRM) are both approaches designed to manage risks, the two have essential differences.
Cyntegrity's latest version of the MyRBQM® Portal, V7.3.1, brings several improvements to enhance your user experience. With a focus on data security, the release includes security updates that predict and prepare for potential breaches.
