Medically underserved populations in rare disease research

  • Discussing population inclusion and access to care and clinical trials regardless of diversity and socioeconomics, with a focus on improving patient care
  • Mental health and well-being: the emotional toll rare diseases take on patients and caregivers
  • Insights on the differences between represented and underrepresented populations on their barriers to care
  • Identifying realistic ways to improve opportunities for all patients

KEYNOTE: Leveraging Machine Learning and Security Orchestration, Automation, and Response (SOAR) to combat cyber threats in clinical data operations

  • 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

Building transparency into rare disease gene therapy trials: what patients and caregivers need to know

  • Understanding why transparency is critical to patient trust and retention in gene therapy trials
  • Recognizing operational challenges unique to gene therapy that impact patients and caregivers
  • Identifying strategies to embed patient and caregiver voices into protocol and schedule design
  • Sharing practical take away communication practices that can strengthen partnerships between trial teams, advocates, and families

From automation to autonomy: How Agentic AI is transforming clinical data management

  • 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.

Why patient-centric data management matters and how can we prioritize this focus?

  • 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?