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.
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.
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 [...]
"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 [...]
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.
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.
Preparing for ICH E6(R3)? Discover how medical monitors can adapt to new safety, compliance, and data integrity standards with advanced monitoring tools.
AI-Enhanced Subject Profiles Elevating Medical Monitoring in Clinical Trials Unified Subject Data Access All critical patient insights in one place AI-Powered Data Quality & Risk Detection Proactively identify data anomalies and risks Customizable Monitoring Flexibility [...]
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).
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!
