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
2nd Annual ACDM Symposium on Risk-Based Quality Management
Join Artem Andrianov and Johann Proeve at the 2nd Annual RBQM Symposium in Brussels. Don’t miss our demo, raffle, and signed copies of The Clinical Researcher’s Guide to RBQM!
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).
Sep
2024
10th Clinical Monitoring & Patient Recruitment Retention Summit (Barcelona)
Don’t Miss Out! We’re excited to announce that our CEO, Artem Andrianov, will be hosting an exclusive workshop at the 10th Annual Clinical Monitoring and Patient Recruitment Retention (CMPRR) Summit in Barcelona this November!
Aug
2024
SCOPE Europe Summit 2024, Barcelona
Celebrate our 10th anniversary with exclusive gifts, including the signed 2024 RBQM Guide by the authors and more fun giveaways!
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. [...]