Navigating ICH E6(R3): New Standards for Medical Monitoring
Preparing for ICH E6(R3)? Discover how medical monitors can adapt to new safety, compliance, and data integrity standards with advanced monitoring tools.
Oct
2024
Oct
2024
Cyntegrity Boosts Clinical Trial Efficiency with MongoDB Atlas
Cyntegrity leverages MongoDB Atlas to transform clinical trials, enhancing data integrity and accelerating drug development. Our AI-augmented MyRBQM® Portal empowers study teams to detect risks early, optimize costs, and ensure regulatory compliance, setting a new standard for safer, faster research. Discover how we’re driving the future of clinical trials.
Oct
2024
ISO 9001:2015 Renewal – Strengthening Quality in Clinical Research
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.
Sep
2024
EMA Releases New Guidelines for Safe Use of Large Language Models in Regulatory Science
The EMA has released key guidelines on the responsible use of large language models (LLMs) in regulatory science. Discover how AI tools like GPT can streamline tasks while addressing privacy and accuracy challenges, and learn about the EMA’s approach to safe and ethical implementation.
Sep
2024
Preparing for the Transition to ICH E6 R3 – Key Sponsor Responsibilities
With the ICH E6(R3) guideline set for approval by October 2024, sponsors face new requirements in risk management, RBQM, and data integrity. Stay compliant and efficient by downloading our free infographic that highlights the key differences between ICH E6(R2) and E6(R3).
Aug
2024
The Real Cost of Delays in Drug Development and the Role of RBQM and QbD
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.
Jul
2024
Enhancing Phase 1 Trials with Risk-Based Quality Management
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. [...]
Jul
2024
How We Support Global SDGs and Social Impact
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!
Jun
2024
Understanding Time-Series Data in MyRBQM® Portal
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.
Jun
2024
5 Questions to Ask When Comparing RBQM Systems
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.