- 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
Archives: Agenda
Ensuring AI Usage in Trials is Audit-Ready: Navigating Regulatory Expectations and Compliance in Responsible AI Adoption
- 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
KEYNOTE: Contraline Case Study: How Can Biotechs Shift Resources to the Right Places to Promote Efficiency and Ensure Responsible AI Adoption in Clinical Trials?
- 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
Reserved for Florence Healthcare
Reserved for Jason Konn Associate Director, Solutions Consulting, eClinical Solutions
PRIZE DRAW
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!
Lunch and Networking
Chair’s opening remarks and early birds prize draw
Best 3 LinkedIn posts from day 1 with hashtag #OCT and @Outsourcing in Clinical Trials Event Series tagged will win a prize in day 2 morning’s prize draw. Deadline end of drinks reception day 1. You must be present to win!
KEYNOTE: The Value of Culture: A Strategic Asset
- 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