On-Demand: Transforming Trial Design at the Program Level

On-Demand Packaging & Labeling At the Protocol Level  Kits are built and labeled upon shipping request  Change in Kit design mid-study  Higher or lower enrollment does not matter  Forecast models are not needed  No rework of packaged drug

Traditional / On-Demand Methods

On-Demand Packaging & Labeling At the Program Level  Ability to share supplies across protocols  Various kit designs across protocols  Change of Protocol start dates

On-Demand Packaging & Labeling

Program Summary  If all kits projected were built 24,534  Actual kits built using On-Demand 7,386  Saving 330% over pack  Ability to adjust to out-of-order start dates  No scheduling conflicts with  1992 items expired, but were never kitted