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.
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).
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!
Discover the potential impact of the draft ICH E6(R3) guidelines on sponsor responsibilities in clinical trials. Download our free infographic for a comprehensive overview.
