Archives: Agenda

• 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

• 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

• 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

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

Sponsored by Dr. Vince Clinical Research

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple prizes or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

Entries from this prize draw will also be entered into the early birds prize draw at 8.20am on day 2, you must be present to win!

The prize draw will take place in TRACK A: Outsourcing & Clinical Operations

Entries from the day 1 prize draw will be entered into the draw. You must be present to win!

• Embedding a strong internal culture to drive consistent execution, accountability, and scientific rigor across cross-functional clinical teams
• Extending cultural alignment beyond the organization to CROs, labs, and technology partners to enable more effective collaboration and shared ownership
• Improving communication, escalation pathways, and transparency to identify and manage risks earlier in complex, outsourced trial environments
• Accelerating decision-making by aligning expectations, behaviors, and governance across global clinical programs
• Reducing operational friction and delays by proactively addressing cultural misalignment and reinforcing shared ways of working