Archives: Agenda

• Learn what Data Governance entails
• How to avoid common challenges to putting Data Governance into practice
• Understand Best practices and keys to successful Data Governance programs

• Discover how the elluminate Clinical Data Cloud provides a flexible foundation for increased data democratization and accessibility in a regulated environment
• Uncover the technology blueprint that enhances data value and enables the future state with efficiency through automation and AI
• See the value of an interoperable ecosystem with an end-to-end solution for clinical data review and analytics needs – from ingestion through submission

• Unpacking the latest terms – RBQM, QBD, “informed data management” whatever is next..
• Understanding why there is a shift in traditional data management
• Requirements and potential barriers to entry
• What is everyone else doing to solve this problem and do we need to do the same thing?

Consistent patient engagement is vital to clinical trial success, yet dropout and non-compliance remain persistent challenges. This session introduces gamification as a scientifically grounded strategy to boost retention, enhance adherence, and streamline trial execution.

• Understand the Science: Explore the behavioral and psychological foundations that make gamification a powerful tool for sustaining patient motivation.
• See Real Results: Review real-world case studies where gamification significantly improved retention, compliance, and trial timelines.
• Apply Proven Methods: Learn practical strategies and best practices for integrating gamified elements into clinical trial protocols.

• Why is FSP becoming a popular choice among sponsor companies and how can this support meeting trial timelines?
• How do strategic alliances impact this decision?
• How to best interact with CDM vendors
• Understanding CDM outsourcing strategies for small to big pharma with differing resources

• A look at how the digital transformation of clinical trials has created unprecedented cybersecurity challenges in protecting sensitive patient data and maintaining trial integrity
• Examining how artificial intelligence and SOAR technologies are revolutionizing clinical data protection against sophisticated cyber threats, particularly Business Email Compromise (BEC) attacks
• Demonstrating how AI-driven security solutions, integrated with SOAR platforms, can detect and respond to threats in real-time while maintaining GxP compliance
• A practical framework for implementing AI-enhanced security measures in clinical data environments, including zero-trust architectures and automated response protocols for protecting electronic data capture systems.
• Gaining actionable insights into building robust cybersecurity frameworks that leverage AI capabilities to protect sensitive clinical data while ensuring regulatory compliance

• Explain how Agentic AI elevates clinical data management beyond rule-based automation.
• Understand the role of reasoning models in enabling autonomous decision-making within clinical trials.
• Identify key ways AI agents can improve data oversight, reduce operational burdens, and support regulatory compliance.
• Explore real-world considerations for deploying Agentic AI within existing clinical workflows.

• Demystifying individual participant data return to modernize and personalize clinical trials
• An end-to-end data-driven patient journey: from patient-friendly DCT conduct to individualized patient data return
• Use-cases: What measures will enable its adoption?
• What can we do to ensure the safe handling of vast amounts of sensitive patient data?