Sessions - Partnerships with Sites & DPHARM

Sessions

This session explores how sponsors, CROs, and sites can incorporate the operational realities and diversity of site environments into early study design and contracting decisions to improve feasibility, streamline execution, and reduce the need for sites to independently interpret and reconstruct workflows that can drive variability.

Key topics include:

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

Many of the operational challenges sites face during study startup and execution originate in early design decisions—long before a trial opens. This session focuses on how sponsors, CROs, and sites can partner earlier in the protocol development process to identify preventable sources of site burden, challenge unnecessary complexity, and ensure site perspectives meaningfully inform trial design decisions.

The discussion will focus on how site input is gathered, translated, and operationalized upstream, as well as the partnership models needed to put site-centricity into practice—not just in principle, but in trial design itself.