PCI Pharma Services Clinical Trial Services

We blend extensive label design technology with flexible primary and secondary packaging suites to provide scalable packaging solutions for all phases of the clinical lifecycle. Our best-in-class packaging design team work with clients to optimize packaging design solutions for precise assembly and release of patient kits for global studies. The same in-house packaging development and design team will also work with you early in the clinical phases to develop a commercially viable packaging solution, delivering time and cost efficiencies as you move towards commercialization. Compliance and Adherence packaging can play an effective role in maximizing patient compliance and adherence by addressing core challenges through the integration of support tools combined with insightful and multifaceted solutions. Our innovative design and development services customize packaging solutions that optimize the interaction of the patient and the product. Clinical Trial Packaging and Labeling With unrivaled experience in packaging and labeling, we combine knowledge, expertise, innovative technologies and a dedicated team of specialists to ensure the highest quality standard of clinical supplies. We can accommodate product needs for light and oxygen sensitivity combined with temperature controls supporting Cold Chain and low-humidity conditions with technological solutions, regardless of packaging type or scale.

Cold Chain Packaging and Labeling Expertise

Our Global Clinical Trial Services include • Pharmaceutical development and clinical trial manufacture including highly potent drug products • Pharmaceutical development and clinical trial manufacture of biologically derived and parenteral products • Pharmaceutical development and clinical trial manufacture of Controlled Drug products • Packaging development and design services • Primary and secondary packaging • Advanced drug delivery and specialist injectable packaging • Final assembly of drug device combination products

PCI is a market leader in the provision of Cold Chain management. We provide specialist expertise in the packaging, labeling, storage and distribution of temperature sensitive clinical supplies including biologically derived and parenteral products. Utilizing state-of-the-art, validated cold plate and dry ice systems, PCI provides innovative solutions at a range of temperatures from controlled room temperature (CRT) (15˚C – 25˚C), through 2-8˚C, -20˚C, -40˚C, -80˚C to -196˚C ensuring product integrity and minimizing temperature excursions. We pride ourselves on our flexibility and where a special requirement is needed, partner with clients to create a bespoke offering at customer specific temperatures. PCI offers split-site Cold Chain storage providing additional security and risk management for client samples.

• Clinical supplies management • Clinical planning and support • Project management • IVRS-IWRS • Qualified Persons (QPs) • Support services • pci | bridge TM delivering real-time data management

Together, delivering life changing therapies.

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