Early Study Design and Stakeholder Alignment: Bringing Site Reality into Protocol and Contracting Decisions

Session details:

This session focuses on how sponsors, CROs, and sites can incorporate the operational diversity of real-world site environments into early study design and contracting decisions to improve feasibility and execution, while reducing the need for sites to independently interpret and reconstruct workflows that drive variability. Key topics:

• Incorporating site input before protocol finalization to identify endpoints, procedures, and workflows that create avoidable operational burden
• Standardizing and simplifying core contracting assumptions upfront (budgets, screen failure terms, amendment triggers) to reduce downstream renegotiation and startup friction
• Balancing scientific ambition with operational feasibility in early design decisions
• Using real-world performance signals to improve feasibility assessment and study design accuracy