Maximizing Site Readiness for ICH E6(R3)
The ICH E6(R3) guideline redefines expectations for clinical trial sites, emphasizing proactive planning, data accuracy, and risk monitoring to enhance participant safety and trial efficiency. Download our presentation for practical insights and strategies to ensure compliance and strengthen collaboration.
Streamlining Clinical Trials: FDA Guidance Meets RBQM Strategy
The recently launched FDA’s draft guidance on protocol deviations highlights the importance of compliance and risk management. Combined with RBQM principles, sponsors can streamline trials, enhance safety, and align with regulations.
ACDM Features RBQM Shift from ClinOps to Data Science
Speaking at the 2nd Annual ACDM Symposium on RBQM, our CEO highlighted how RBQM has evolved from supporting Clinical Operations to becoming an integrated approach to data management.
Empowering Trial Participants: The Right to Access Data and How Sponsors Can Deliver with Ease
Clinical trial participants have the right to access their personal data, a principle emphasized in the ICH E6(R3) guidelines. Sponsors must ensure transparency and provide participants with their data in a clear and accessible format. Our Subject Profiles tool offers a streamlined solution, enabling sponsors to generate comprehensive reports efficiently, thereby meeting regulatory requirements and enhancing participant trust.
Why Sponsors Should Embed RBQM Principles and Adaptive Monitoring Strategies in Protocol Design
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.
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.
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.
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.
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.
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).
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.
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 [...]