Leadership Roundtable: Implementing QbD with AI
Join Cyntegrity & Microsoft in Frankfurt for a leadership roundtable on AI & QbD with guest speaker Andrew Warrington, (Senior Industry Advisor.)
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.
Synergy of QbD, RBM, and RBQM in Trials
Clinical trials require a comprehensive approach to ensure quality and efficiency. Quality by Design, Risk-Based Monitoring, and Risk-Based Quality Management work together to achieve these goals, focusing on building quality into the trial process, targeting monitoring activities, and continuously improving trial quality.
Bridge CRF Data Capture & RBQM Analytics for ICH E6(R3) Compliance
As presented at the DIA 2025 Global Annual Meeting: Learn how early, joint CRF and RBQM planning closes critical data gaps Late stage CRF design and last minute RBQM roll-out can affect patient safety oversight and data quality. In this [...]
DIA 2025 Short Course (virtual)
Join our hands-on online RBQM & QbD short course at DIA 2025 on June 10. Learn to assess risks, define KRIs/QTLs, and apply ICH E6(R2/R3).
Efficient Clinical Data Management for On-Time Trials
Efficient Clinical Data Management Accelerating Data Oversight in Clinical Trials Unified Data Access All critical information in a single, centralized view—combining EDC, lab, and external data sources Proactive Data Quality & Risk Detection Pinpoint discrepancies early and move forward with fewer [...]
AI-Enhanced RACT
"Ask AI" RACT AI-Enhanced Risk Assessment in Clinical Trials Smarter Workflows Address AI-detected risks during protocol design or transfer selected risks to RACT Targeted Mitigation Receive AI-suggested mitigation actions for relevant risks Self-Learning Adaptability Libraries [...]
Adopting ICH E6(R3): What Sponsors, CROs, Sites, and Participants Need to Know
The ICH E6(R3) guideline was formally adopted on January 6, 2025, introducing reinforced principles for clinical trial conduct. This final version builds on its draft with clarified expectations and some notable revisions. Let’s explore the highlights and the implications for stakeholders.
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.
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.