Complex Multi-Arm Clinical Trial Packaging Program

A Fortune 500 pharmaceutical company needed packaging support for a complex Phase III adaptive clinical trial. The trial design included 4 treatment arms with patient-level randomization, requiring patient-specific kit configurations that changed based on treatment assignment and visit schedule.

Clinical sites were located across 12 countries, each with distinct labeling requirements, language needs, and regulatory standards. The adaptive trial design meant that packaging configurations could change based on interim analysis results, requiring a packaging partner with the flexibility to respond quickly to protocol amendments.

Meridan designed patient-specific kits with blinded labeling that maintained the integrity of the randomization scheme across all 4 treatment arms. Each kit was configured to match the specific treatment assignment and visit schedule for individual patients, with labeling that concealed treatment identity while providing all required regulatory and safety information.

The team integrated directly with the sponsor’s Interactive Response Technology (IRT) system, enabling automated kit assignment and real-time inventory management across all 12 countries. Multi-language labeling was managed through a centralized artwork and translation workflow that ensured consistency and accuracy across all country variants.

Meridan also provided comparator sourcing and over-encapsulation services for the active comparator arm, managing the procurement and blinding of commercial product to match the investigational product’s appearance. The adaptive trial design was supported through flexible production scheduling that allowed rapid response to protocol amendments.