SW-122009 - USA (Massachusetts) - GLOBAL - HEALEY ALS Trial Next Generation Platform - Deadline November 20,2026

– Vendor needs to provide HEALEY ALS trial next generation platform. – Innovative Design:• Streamlined design phase, including data–driven simulations to tailor each regimen, followed by rapid execution.• Primary analysis model jointly evaluating function and survival.• Flexibility at the regimen level in study objectives, outcome selection, endpoint hierarchy, and sample size.• Inclusion of biomarkers and novel outcome measures for sensitive signal detection.– Statistical Rigor:• Planned interim analyses to enable adaptive decision–making.• Increased statistical power through shared placebo data across treatment regimens.• Advanced statistical modeling to account for potential differences in shared placebo participants.– Record Breaking Operational Performance:• Rapid entry and efficient start–up of new treatment regimens within the ongoing platform trial infrastructure.• Access to Key Opinion Leaders (KOLs) across major domains of ALS science.• Active engagement of the ALS community to support efficient enrollment.