Clinical Secondary Packaging, Labeling & Kitting
How Can Packaging, Labeling and Kitting Adapt to Changing Clinical Trial Needs?
GMP-compliant clinical trial secondary packaging, labeling, and kitting services are designed to support evolving protocols, tight timelines, and complex global trial designs. These capabilities enable sponsors to maintain flexibility across study phases while ensuring consistency, accuracy, and compliance in the preparation of clinical materials for global distribution.
Tanner delivers scalable, GxP-compliant operations that help maintain study integrity, support regulatory compliance in clinical trials, and reduce re-work as trials change.
Our teams manage country-specific labeling requirements, Just-in-time labeling, and rapid adaptation to protocol amendments, ensuring materials are prepared and delivered efficiently to clinical sites while minimizing delays and operational risk.
Our Capabilities
Secondary Packaging
GMP-compliant secondary packaging designed to support evolving clinical trial protocols and global distribution requirements.
-
Secondary packaging for investigational and comparator products, ancillaries, and study materials
Packaging aligned to protocol design, visit schedules, and site workflows
Regional and site-specific configurations
-
Packaging designs that maintain study blinding and integrity
Support for randomized and controlled trial structures
Coordination with labeling and IRT/RTSM systems
-
Re-packaging driven by protocol amendments or study changes
Controlled re-work to reduce delays and excess waste
Support for geographic expansion or late-market additions
-
Solutions for ambient, refrigerated, frozen, and ultra-low products
Packaging designed to support downstream cold chain logistics
Documented planning for excursion risk mitigation
-
Alignment with comparator sourcing and global distribution strategy
Design approaches that reduce operational complexity and inventory fragmentation
Labeling
Global clinical trial labeling designed to support regulatory compliance, blinding integrity, and protocol flexibility.
-
Carton and kit labels
Booklet and multi-panel labels for extensive regulatory content
Over-labels and re-labels for amendments or regional updates
-
Single-country labeling aligned to local regulations
Multi-Country Labeling (MCL) to reduce complexity and inventory burden
Hybrid strategies based on regional and trial design considerations
-
Labeling structured to preserve study blinding
Support for randomized trial designs
Alignment with packaging and kit configuration
-
Final labeling decisions aligned to shipment timelines
Reduced re-work and inventory exposure
Flexibility for regulatory updates and protocol amendments
-
Labeling aligned to IRT-driven randomization
Kit numbering and traceability support
Coordination with supply forecasting and resupply logic
-
Multi-language labeling management
Translation coordination aligned to regulatory expectations
Controlled review, version control, and documentation
Clinical Kitting
Site-ready clinical kitting designed to support precision, compliance, and operational control.
-
Visit-based and patient-based kit builds
Kits incorporating comparators, IMPs, ancillaries, and study materials
Alignment with protocol dosing schedules and site workflows
-
Kit designs preserving study blinding
Support for randomized and controlled trial structures
Integration with IRT/RTSM systems for allocation and assignment
-
Country- and site-specific kit configurations
Support for phased rollouts and geographic expansion
Flexible approaches to regulatory and logistical variability
-
Kitting aligned to enrollment and resupply strategy
Reduced excess production and inventory waste
Rapid response to protocol amendments or demand shifts
-
Kit numbering and tracking throughout the supply chain
Chain-of-custody documentation supporting audit readiness
Alignment with packaging, labeling, and distribution workflows
Tanner-Owned Facility & Operations
Our US-based facility and operational workflows are designed to support clinical trial secondary packaging, labeling, and kitting with a focus on compliance, control, and efficiency.
GMP Clinical Packaging & Labeling
GMP packaging and labeling suites purpose-built for clinical trials
Designed for investigational and comparator products
Segregated workspaces to maintain study, product, and batch separation
Controlled GMP Workflows
Secure, segregated gowning and production areas
Continuous temperature and humidity monitoring
Controls supporting product integrity and inspection readiness.
Multi-Zone Temperature Control
Ambient, refrigerated, frozen, and ultra-low temperature capabilities
Temperature-controlled zones for storage and active packaging, labeling, and kitting
How We Deliver Clinical Trial Solutions
Explore real-world examples of how we navigate regulatory, geographic and supply complexities to deliver compliant, global access to essential therapies.