Participant-Centric RTSM Designs: Supply Management For Advanced Therapies And Direct-To-Participant Trials

Supply built around pooled inventory and site-centric workflows starts to fail when a therapy is manufactured for one participant, remains usable for hours, or is delivered to a home address the sponsor should never see.

This white paper looks at the market forces pushing participant-centric supply into the mainstream and the operational demands that follow: chain of identity, half-life and expiry logic, multi-leg cold chain, role-based data visibility, and country and site barriers. It also puts directional figures on what avoidable supply failures can cost a mid-size Phase II cell therapy program.

Explore the analysis to see how the requirements fit together across the full lifecycle.