Archives: Agenda

• Planning transitions between trial phases while maintaining clear governance and operational continuity for small biotechs as well as large pharma
• When does governance not happen when it should?
• Fit-for-purpose governance: Tailoring oversight strategies to the biotech environment, where agility and limited resources are critical
• Strengthening responsible vendor oversight with up-to-date documentation and compliance aligned with evolving ICH guidance and regulatory expectations

Moderator: Krissy Meckel Parker, Associate Director, Clinical QA, Neurocrine Biosciences

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Sponsored by Dr. Vince Clinical Research

• Exploring the “flight to quality” as biopharma investment concentrates on high-potential therapeutic areas
• Examining today’s funding landscape and shifts in indication focus
• Moving from AI pilots to practical implementation across clinical research
• Highlighting emerging approaches and innovations reshaping trial delivery

• The black box between scientific intent and clinical operations: Are our well-crafted protocols resting on a fragile chain of human actions?
• Four operational pitfalls at the site level: Where does trial execution break down?
• The trap of feeding black box data into AI: Are we simply accelerating the interpretation of bad execution data?
• Questions to ask your vendors about opening the execution black box

• Understanding the evolving regulatory landscape for AI-enabled trials
• Preparing for audits and inspections to avoid compliance pitfalls
• Lessons learned from real-world AI adoption across sponsors and CROs
• Implementing responsible AI practices to accelerate innovation without regulatory risk

• Responsible AI and Governance: Establishing practical frameworks for AI adoption, data privacy, and oversight in clinical research
• Site selection and start-up challenges: Lessons learned from initiating early-phase global clinical studies and overcoming common operational bottlenecks
• Smarter resourcing strategies: Balancing lean teams, CRO oversight, and cross-functional priorities to maximize productivity without compromising quality

A market-strategy read on why connectivity is the precondition, and AI is only the layer on top

• The tax that lean teams can’t absorb: Why 20+ disconnected site systems quietly cost small biotechs days, dollars, and audit findings
• You don’t need more people, just fewer gaps: How one cancer center cut protocol-training time in half and slashed monitoring findings 86% by connecting a single workflow
• Why connectivity beats a rushed AI bet: The case for fixing your execution layer before you buy the agentic-AI story

• Exploring the emerging trends shaping the future of RBQM, from evolving guidance on risk, quality, and sponsor oversight, including ICH E6(R3) and ICH E8(R1)
• Examining FDA’s emerging risk-based framework for the use of AI in support of regulatory decision-making
• Considering how AI and integrated analytics can strengthen oversight and decision-making across trials and partners
• Understanding how connected data and platforms can reduce fragmentation and support more consistent, scalable, future-ready oversight strategies