- Overcoming financial constraints when budgets are limited and resources tight
- Fierce site competition: How start-ups can compete with established companies for sites
- Utilizing effective planning to improve study and program efficiency without compromising patient safety
- Agile and adaptable: Being prepared to adjust your strategy and approach as needed
Archives: Agenda
Sponsor’s oversight responsibilities on regulatory submissions for outsourced clinical trials – Integrating the Target Product Profile
- Sponsor Accountability: Ultimate responsibility for regulatory submissions remains with the sponsor.
- Target Product Profile Integration: Acts as a strategic anchor for submission quality and alignment.
- Effective Oversight: Governance, communication, and risk management ensure compliance in outsourced settings.
Beginning with the end in mind: Building effective long-term follow-up strategies in complex therapy trials
- Emphasize the critical role of LTFU in cell and gene therapy trials and why early planning matters
- Outline key logistics and operations considerations (site readiness, patient tracking, communication pathways) that minimize follow-up costs and support successful LTFU models
- Highlight the importance of early patient education and engagement and use of remote or virtual visits to improve retention and compliance
- Share broad learnings from past programs where proactive LTFU planning facilitated compliance and improved cost predictability
Registration & Refreshments
Chair’s introductions
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 devices or Amazon giftcards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!
END OF DAY 1 AND NETWORKING DRINKS
Sponsored by EmVenio
Join us in the atrium for a drinks reception
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 devices or Amazon giftcards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!
Is AI enough? Why smarter site identification still needs human-centred strategies
- AI has accelerated site identification and feasibility through predictive analytics and historical data.
- ICON’s OneSearch platform enables faster identification of high-performing sites.
- AI alone cannot resolve all study start-up challenges.
- Successful site selection requires human-centered strategies beyond capacity metrics.
- Resource constraints and operational complexity make site success increasingly challenging.
- This session explores how ICON’s approach has evolved over five years of AI-driven selection, combining technology with human-centred strategies.