Clinical trial packaging, labeling, and patient kit assembly are core functions within the clinical supply chain that ensure investigational products are delivered to study sites and patients in a compliant, traceable, and usable format. These services cover the packaging of investigational medicinal products, comparator drugs, and ancillary supplies, as well as the labeling of those materials in accordance with global regulatory requirements.
Clinical packaging must comply with Good Manufacturing Practice standards, regional regulations such as FDA 21 CFR Part 312, and international guidance, including ICH GCP. Errors in labeling, kitting, or documentation can delay trials, invalidate study data, or trigger regulatory findings.
According to Grand View Research, the global clinical trial supply and logistics market was valued at approximately USD 22.4 billion in 2023 and is projected to grow at a compound annual growth rate above 7 percent through 2030, driven by increased trial complexity and decentralized study models.
Growth is also linked to the rise of patient-centric trials. According to Clinical Trials Arena, over 60 percent of new clinical trials now incorporate decentralized or hybrid elements, increasing demand for patient kit assembly, home shipment packaging, and labeling flexibility.
The companies listed below represent leading providers of clinical trial packaging, labeling, and patient kit assembly services, selected for their global scale, regulatory expertise, operational reliability, and experience supporting Phase I through Phase IV studies.
Website: https://www.pciservices.com
PCI Pharma Services is one of the largest global providers of clinical trial packaging and labeling services. The company supports solid oral doses, sterile injectables, biologics, and advanced therapies across all clinical phases. PCI offers GMP-compliant packaging, multi-language labeling, randomization support, and global distribution coordination.
PCI is particularly strong in complex study designs, including adaptive trials and multi-regional studies requiring frequent label updates. Its integrated manufacturing and packaging capabilities allow sponsors to move efficiently from clinical to commercial scale. PCI operates facilities across North America, Europe, and Asia, supporting global trial execution with consistent quality systems.
Website: https://www.catalent.com
Catalent Clinical Supply provides end-to-end clinical supply services, including packaging, labeling, storage, and distribution. The company supports oral solids, biologics, cell and gene therapies, and temperature-sensitive products requiring cold chain handling.
Catalent’s clinical packaging services include bottle filling, blister packaging, sachets, and specialized formats for injectable products. The company also offers interactive response technology integration and demand forecasting to support trial continuity. Catalent’s global footprint allows it to manage region-specific labeling requirements and rapid resupply for international trials.
Website: https://sharpservices.com
Sharp Clinical Services specializes in clinical packaging, labeling, and supply chain management for pharmaceutical and biotech companies. The company has deep expertise in comparator sourcing, over-encapsulation, and blinded packaging for randomized controlled trials.
Sharp provides patient kit assembly, returns management, and destruction services, supporting full clinical supply lifecycle management. Its facilities are GMP-compliant and equipped to handle both ambient and cold chain products. Sharp is often selected for studies with complex blinding requirements and multi-country labeling strategies.
Website: https://www.thermofisher.com/clinicalservices
Thermo Fisher Clinical Services offers comprehensive clinical trial supply solutions, including packaging, labeling, storage, and global distribution. As part of Thermo Fisher Scientific, the division integrates logistics, cold chain management, and regulatory support.
Thermo Fisher supports small molecule drugs, biologics, and advanced therapies. Its patient kit assembly services are designed to support decentralized trials, including direct-to-patient shipments. The company’s global infrastructure allows rapid response to protocol changes and region-specific labeling updates.
Website: https://www.almacgroup.com
Almac is a global provider of clinical trial packaging, labeling, and supply chain services with a strong reputation for regulatory compliance and operational precision. The company supports packaging for oral, injectable, and biologic products and offers sophisticated labeling solutions for complex global trials.
Almac also provides interactive response technology, forecasting, and supply optimization services. Its experience with adaptive trials and oncology studies makes it a frequent partner for sponsors conducting late-phase or multinational research programs.
Website: https://www.yourwayclinical.com
Yourway is a clinical supply services company focused on flexible, sponsor-centric solutions for packaging, labeling, and patient kit assembly. The company supports early and mid-phase trials and is known for its responsiveness and customization.
Yourway provides GMP-compliant packaging, relabeling, and clinical kit assembly with an emphasis on speed and adaptability. Its services are often used by emerging biotech companies requiring close collaboration and rapid execution during trial startup and protocol changes.
Website: https://www.myonex.com
Myonex specializes in comparator sourcing, clinical packaging, and labeling services for global trials. The company supports blinded and open-label studies and offers expertise in sourcing reference products across multiple markets.
Myonex provides packaging and labeling services that align with global regulatory expectations, ensuring consistency across regions. Its ability to manage comparator supply chains makes it a key partner for complex trials where sourcing and packaging must be tightly coordinated.
Website: https://www.ancillare.com
Ancillare focuses on ancillary supply sourcing, patient kit assembly, and clinical packaging services. The company supports trials by managing non-investigational materials such as medical devices, consumables, and diagnostic supplies.
Ancillare’s packaging services ensure that all trial materials are assembled into compliant patient kits, reducing site burden and improving trial execution. The company’s expertise is particularly valuable for decentralized and hybrid trials that require complex kit configurations and direct-to-patient delivery.
Website: https://www.marken.com
Marken is a global clinical logistics provider with expanding capabilities in clinical packaging and labeling support. The company is best known for temperature-controlled logistics and direct-to-patient delivery services.
Marken supports patient kit distribution, returns, and resupply, particularly for trials involving biologics, cell and gene therapies, and time-sensitive materials. Its infrastructure supports regulatory-compliant handling across more than 200 countries and territories.
Website: https://www.daklapack.us/services/kitting
DaklaPack US provides flexible packaging and labeling solutions that support clinical trial logistics, diagnostics, and patient sample management. The company offers custom-printed packaging, barrier pouches, and kit components designed for regulated environments.
DaklaPack’s expertise in small batch production and customization aligns well with early phase trials and decentralized study models. Its focus on material optimization and sustainability also supports evolving expectations around environmental impact in clinical supply chains.
Clinical trial packaging involves preparing investigational products, comparators, and ancillary supplies in formats that maintain product integrity, blinding, and regulatory compliance throughout a study.
https://www.grandviewresearch.com/industry-analysis/clinical-trial-supply-logistics-market
Clinical labeling ensures correct dosing, patient safety, and regulatory compliance across regions. Errors can lead to trial delays or regulatory findings.
https://www.fda.gov/drugs/investigational-new-drug-ind-application/labeling-investigational-drugs
Patient kit assembly involves grouping investigational products and ancillary supplies into complete kits for trial participants or study sites, improving compliance and reducing operational errors.
