This article explains why sponsors should adopt RBQM principles early in trial planning, supported by regulatory recommendations, and highlights the benefits of early implementation compared to addressing these elements later in the monitoring plan—or not at all.
Preparing for ICH E6(R3)? Discover how medical monitors can adapt to new safety, compliance, and data integrity standards with advanced monitoring tools.
Cyntegrity is proud to announce the renewal of our ISO 9001:2015 certification. This renewal highlights our commitment to maintaining the highest standards of quality in clinical research, ensuring consistency, risk management, and regulatory compliance. Discover how this certification continues to drive our mission for excellence.
Recent Tufts CSDD research shows that the cost of clinical trial delays is much lower than previously thought, underscoring the importance of Risk-Based Quality Management (RBQM) and Quality by Design (QbD). Cyntegrity's Johann Proeve, PhD, and Anastasia Shapovalova, MSc, highlight the benefits of a data-driven approach and live process monitoring in enhancing trial efficiency.
The Importance of First-in-Human (FIH) Trials First-in-Human (FIH) clinical trials, also known as Phase 1 trials, are a pivotal stage in drug development. Conducted with a small group of healthy volunteers, these studies mark the first testing of a new drug in humans. [...]
At Cyntegrity, our remote work model supports the UN's Sustainable Development Goals (SDGs) by promoting inclusivity, reducing environmental impact, and fostering social responsibility through initiatives like the Butterfly Challenge. Join us in making a positive global impact!
Discover how the MyRBQM® Portal uses advanced time-series data storage to preserve every data point in its original context, enhancing Risk-Based Quality Management (RBQM) by allowing you to track study progress and understand past decisions.
When evaluating Risk-Based Quality Management (RBQM) systems, asking the right questions is crucial to ensure you choose a solution that meets your needs and aligns with regulatory guidelines. This post outlines five key questions to consider.
Enhance your clinical due diligence in pharma M&A with our Quality of Clinical Data Report. Watch our webinar recording and explore mindsON RBQM workshops for practical RBQM roll-out advice.
Our November 2023 event, “Responsible AI in Clinical Trials,” gathered industry experts and over 160 attendees to discuss AI's future, opportunities, and challenges. Keith Dorricott shares insights from the summit and highlights why you should book for the next one on October 8-9, 2024!
