Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Unlike commercial pharmaceutical packaging, the primary consideration in clinical trial packaging services is protecting the product quality and reliability for research.
Pharmaceutical companies demand reliable packaging solutions from clinical trial packaging providers that deliver products for various types of clinical trials such as randomisation and blinding studies and adapt to the specific needs of each trial.
Finding the best clinical trial packaging companies in contract manufacturing
Pharmaceutical Technology has listed some of the leading clinical trial packaging companies, based on its intel, insights, and decades-long experience in the sector.
The list includes clinical trial packaging services providers with expertise in primary packaging, and secondary packaging and providers of innovative and cost-effective clinical trial packaging solutions. Furthermore, the list includes labelling, storage, and logistics service providers.
The information contained within the download document is useful for clinical trial coordinators and managers, senior procurement executives, clinical packaging development specialists, product development managers, and any other individual associated with clinical trial packaging design and services.
The download contains detailed information on clinical trial packaging companies in contract manufacturing and their product and service lines, alongside contact details to aid your purchasing or hiring decision.
Clinical trial packaging services and labelling solutions
Pharmaceutical companies require different clinical trial packaging and labelling solutions including, but not limited to:
- Primary packaging, including blistering, bottling, pouching and over-encapsulation
- Secondary packaging, including blister packaging, labelling, kit assembly and card-sealing
- Automated pre-filled syringe assembly and labelling
- Multi-panel and multi-language clinical labelling, and
- Serialisation
Key considerations for selecting clinical trial packaging companies
Contract manufacturing organisations handle various types of clinical trial materials, including biologic drugs. The packaging material used, the kit design and protection during transportation are important aspects that need to be considered while selecting a clinical trial packaging services provider.
Innovative pharmaceutical packaging solutions such as blow-fill-seal vials, pre-filled vial and syringe designs, snap-off ampoules, and child-resistant packs are being increasingly used in clinical trial applications.
Furthermore, the trend of decentralised clinical trials is driving the demand for patient-centric kits that can be easily used by patients at their homes.
FAQs
What are the key considerations for clinical trial packaging?
Key considerations for clinical trial packaging include ensuring product stability, maintaining blinding when required, and complying with strict regulatory guidelines. Packaging must also account for the logistics of multi-site trials, temperature-sensitive materials, and patient-centric designs. Factors like tamper-evidence, traceability, and compatibility with automated systems are crucial to streamline the trial process and enhance efficiency. For trials with varying locations or home-based patients, packaging must ensure ease of transport and use, without compromising the integrity of the investigational products.
How does clinical trial packaging ensure compliance with regulatory standards?
Clinical trial packaging must adhere to strict regulations, ensuring that all labelling is accurate, multi-lingual if necessary, and provides clear handling instructions for patients and medical staff. Compliance includes incorporating patient information leaflets and safety warnings as mandated by authorities like the MHRA (Medicines and Healthcare products Regulatory Agency) in the UK, and the FDA (Food and Drug Administration) in the US. Additionally, packaging must protect the integrity of the product throughout its distribution, ensuring that all materials meet GMP (Good Manufacturing Practice) requirements.
What role does secondary packaging play in clinical trials?
Secondary packaging plays a critical role in consolidating the primary packaged investigational products with trial documentation, instructions, and labelling. It often includes outer boxes, cartons, and security seals, and is designed to ensure that trial materials remain secure and tamper-evident throughout transportation and storage. The secondary packaging also simplifies the kit-building process, ensuring all necessary components are present for the clinical trial sites, which is particularly important for global trials that involve multiple locations and patients.
How do temperature control solutions impact clinical trial packaging?
Temperature-sensitive pharmaceuticals, such as biologics or vaccines, require highly specialised packaging to maintain their efficacy throughout the trial process. Controlled temperature packaging (e.g., cold chain solutions) is crucial to keep products within specific temperature ranges during transit and storage, whether refrigerated or frozen. Innovative packaging solutions often incorporate phase change materials, insulated shippers, and temperature-monitoring devices to ensure product stability. Failing to maintain proper conditions can compromise trial data, leading to regulatory non-compliance and costly delays.
How do clinical trial packaging services accommodate decentralised trials?
In decentralised trials, where patients participate remotely, packaging services must adapt to home-based delivery while ensuring product integrity. This often involves creating patient-friendly packaging designs that are easy to handle and provide clear instructions, while also safeguarding the product during transit. Packaging for decentralised trials may also include features such as tamper-evident seals, patient return kits, and digital tracking to monitor product use and compliance. These features ensure that clinical trials maintain their rigorous standards, even outside of traditional clinical environments.