Archives: Agenda

Participant-Centric RTSM Designing

  • Managing individualized supply models – moving beyond “one product, many patients” to patient-specific manufacturing, labeling, and release (e.g., CGTs, radiopharmaceuticals) while maintaining chain-of-identity and handling strict usability constraints
  • Navigating DTP and logistic complexity – coordinating multi-stakeholder ecosystems (sites, patients, depots, logistics) while ensuring data privacy and adapting to country, site, and patient-level variability
  • Enabling end-to-end control and compliance – leveraging RTSM solutions to ensure traceability, secure data handling, temperature and expiry management, and seamless oversight across the full supply lifecycle

LIVE DEBATE Debating the AI hype – what’s really happening on the ground

  • Questioning whether current AI tools are overpromising and underdelivering in real clinical operations
  • Exploring where AI implementations are stalling due to data quality, integration and change-management challenges
  • Examining regulatory, validation and inspection readiness concerns that are slowing adoption

Operationalizing PROs and digital endpoints in early oncology: faster decisions, better data, stronger Phase III

  • Embedding patient-reported outcomes (PROs) early to streamline oncology trial operations and control cost: How PROs in Phase I/II can deliver clearer tolerability and patient-experience data, supporting faster decisions and more efficient Phase III planning
  • Operationalizing digital endpoints (eCOA) for speed, quality, and patient-centricity: Practical strategies for configuring eCOA to accelerate startup, and reduce patient burden
  • Using digital endpoints to enable risk-based oversight and phase-to-phase continuity: How continuous, real-time eCOA data supports centralized/risk-based monitoring, and robustness of regulatory and scientific outcomes

PANEL DISCUSSION Rebuilding trust across sponsors, CROs and sites by addressing the human factors behind operational success

  • Exploring how communication styles, cultural mismatches and unspoken assumptions derail trials more than processes or systems
  • Supporting teams by aligning expectations, roles and behaviour before contracting, not after issues emerge
  • Strengthening long-term partnerships with transparent conflict resolution models and joint decision-making practices

Moderator: Peter Barschdorff, Vice President, GlobalData

From protocol design to operational reality: making clinical trials work before they start

  • Transforming Protocol to Execution: How AIKA uses advanced AI to streamline protocol generation, enhance feasibility analysis, and reduce study start-up timelines
  • Data-Driven Decision Support: Leveraging real-time operational insights and predictive analytics to improve trial performance and risk mitigation
  • Scaling Clinical Operations: Practical examples of AIKA in action, from automated task orchestration to cross-functional collaboration that drives efficiency and quality