Archives: Agenda

• How CRO incentive plans are typically structured and where misalignment starts
• Why they often fail: volume-driven KPIs over quality and outcomes
• The impact on timelines, data quality, and sponsor–CRO relationships
• Moving towards outcome-based, shared risk/reward models
• Practical examples of more effective incentive frameworks

• Interpreting what has materially changed under ICH E6(R3), including governance, risk-based quality management, and sponsor oversight expectations
• Sharing how companies are operationalizing the updated guidance six months in—what has actually changed in trial design, conduct, and oversight
• Identifying common implementation challenges, grey areas, and lessons learned when aligning internal processes, CRO partnerships, and inspection readiness

Moderator: Carrie Lewis, Executive Director, Clinical Program Optimization, Keenova Therapeutics

• How historical male-centric assumptions shaped clinical research — and how this affected evidence generation, safety signals, and patient outcomes
• What has changed in prioritizing sex and gender today — including regulatory focus, better data capture, and new enabling tools
• How sex differences appear across the research lifecycle — using real-world case studies to show impacts on trial interpretation and success
• Why this is a pivotal moment for clinical research — with sex-aware data driving better insights, outcomes, and more representative evidence

Format and focus 
This will be a 40‑minute, highly practical, non‑commercial workshop built around a real FDA Warning Letter scenario in clinical research. Participants will be guided through a structured 4‑phase response framework: (1) problem analysis, (2) fact‑finding, (3) root cause analysis and (4) CAPA definition. We will then briefly show how the same scenario can be processed in our internal AI tool to compare human and AI reasoning, with the emphasis on methodology and lessons learned rather than on a product demo or sales content.

Learning objectives
By the end of the workshop, participants will be able to:

• Apply a structured 4‑phase approach to inspection findings (problem framing, fact‑finding, root cause analysis, CAPA design).
• Recognise common pitfalls seen in FDA Warning Letters (symptom‑level CAPAs, weak root cause statements, missing effectiveness checks) and how to avoid them in their own organisations.
• Understand where AI can realistically support, but not replace, human QA judgement in root cause analysis and CAPA design for inspection readiness.

• 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