Archives: Agenda

• Embedding quality and governance principles earlier in digital and analytics initiatives
• Understanding how trusted data foundations enable faster, more confident innovation
• Exploring where governance accelerates innovation rather than slowing it down

Moderator: John Seman, CEO, Revitale Pharma

• 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

• 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

• 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

• 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

• Exploring why innovations stall at pilot stage
• Supporting organizations to scale meaningful improvements
• Strengthening alignment and accountability across teams

Moderator

John Seman, CEO, Revitale Pharma

• 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