Archives: Agenda

• Providing an overview of the CDISC Open Rules project
• What are CDISC Conformance rules
• Insights about the CDISC-FDA collaboration
• How can CDISC Open Rules help in Data Management Projects
• What’s coming next

• Overcoming Interoperability Challenges: Breaking Down Data Silos for Seamless Care Coordination.
• Leveraging AI and Machine Learning to Enhance Clinical Decision Support and Predictive Analytics.
• Implementing Robust Data Governance and Security Measures to Ensure Patient Privacy and Regulatory Compliance.
• Harnessing Real-Time Data Analytics to Drive Personalized Care and Improve clinical outcomes.

As the landscape of clinical research continues to evolve, the integration of Artificial Intelligence (AI) presents unprecedented opportunities for transforming clinical data management. This presentation will explore how AI is being harnessed to revolutionize solutioning and accelerate clinical trials, focusing on three main areas:

• Master Data Management: Implementing AI tools to enhance the efficiency, accuracy, and compliance of data handling, driving significant improvements in trial outcomes.
• Transactional Workflows: Utilizing AI to streamline and optimize clinical trial processes.
• Agentic Workflows: Leveraging a centralized AI platform to build robust solutions that automate and improve decision-making in clinical research.

What are the practical challenges, innovative solutions, and the potential return on investment (ROI) that AI brings to clinical data management, as we move from theory to therapy.

• Test-Start-Scale – methodology that takes digital innovation on a journey from idea through refinement, all the way to wider-scale use and BAU
• Data-driven approach which proves the value of the technology in a controlled fashion
• Adoption of new digital capabilities with confidence and satisfaction from end user perspective

• Are high dropout rates and patient disengagement slowing down your clinical trials and driving up costs? An introduction to gamification as a proven solution to keep patients motivated, reduce dropout rates, and improve compliance.
• Get actionable insights on integrating gamification into your trials. Learn practical strategies to boost patient engagement while ensuring accurate data collection.
• Explore real-world success stories. Discover how increased patient retention translated into shorter trial timelines, lower costs, and better trial outcomes.
• See how gamification drives efficiency and savings. Understand how engaging patients more effectively can streamline your trials, reduce time to market, and significantly lower costs.

• Introduction to AI
• Overview of AI in Drug Discovery
• Trends Impacting AI in Drug Discovery
• Analysis of Drugs Developed by AI

• Overview of the RBQM principles
• How can we apply those principles to Vaccine development?
• Vaccine case study from CTQs factors to Submission