Clinical Secondary Packaging
Our bespoke sourcing strategy is where our clients really understand the value of working with us.
Overview
Clinical Secondary Packaging Design & Development
We offer bespoke clinical secondary packaging & labelling services to complement our award-winning comparator business. Clinical secondary packaging is a vital step in the supply chain and involves the label design, language translations and application of labels to a wide range of package types including bottles, blister cards, vials, syringes, pouches, tubes, inhalers and other devices. This culminates in the creation of patient kits that are then released and distributed via our global storage and distribution network to ensure they arrive on time to treat patients participating in clinical trials across the globe.
Label Design, Randomisation & Language Translations
Our business managers can expertly design single-panel and multi-panel labels, in addition to a variety of booklet labels. We offer in-house label printing services and labels can be designed to maintain adhesion at a range of different temperatures, +15°C to +25°C, +2°C to +8°C, -25°C to -15°C and -80°C to -60°C. We also offer blinding, sourcing of randomisation lists, and label text translations, if you require.
Controlled Room Temperature and Cold Chain Packaging & Labelling
Customised assembly of patient kits takes place in designated rooms and spaces at controlled ambient (+15°C to +25°C), refrigerated (+2°C to +8°C) or frozen (-25°C to -15°C) temperatures to ensure that all medicinal products, including those with limited stability data are maintained at an appropriate temperature throughout the packaging & labelling process.
QP Services
An assigned Qualified Person (QP) will help to guide you from the very beginning in terms of the documentation required for QP release. If necessary, the QP can issue a declaration for a Clinical Trial Application (CTA) to cover the importation of a medicinal product into the EU. Once the patient kits have been produced, the QP will perform the mandatory release and certification of the patient kits, so that they can be distributed seamlessly to clinical sites within EU countries.
Just in Time (JIT) Labelling
JIT protocols can be created to perform certain modifications to clinical supplies, such as label application to patient kits that have already been QP released. For example, the addition of a label displaying the protocol or study number prior to dispatch to clinical sites.
Global Storage, Distribution, Returns and Destruction
Our highly trained logistics experts handle the storage and distribution of all types of packaged and labelled medicinal products for clinical trials, offering sound and upfront knowledge in relation to the customs documentation required for import/export to reduce the risk of delays to your shipments. Coupled with this, we offer a comprehensive returns and destruction service across our entire global network.
We only work with carefully chosen and approved distribution partners, from express carriers to speciality courier services dedicated to the global storage and transport of pharmaceutical products. We use a full range of validated shipping and packing configurations combined with precise temperature dataloggers to make certain all medicinal products arrive at their destination in the best possible condition.
Our teams will work with you to develop a bespoke distribution protocol and strategy specific to the unique needs of your program or study.