Packaging and labelling

Whatever your drug or device packaging needs may be, Clinigen has the flexibility, modern tools, and proven qualifications to handle your projects, through all stages of development. For 25-plus years, we have worked tirelessly to make sure your clinical trials are smooth, waste-free, and always on time. Clinigen performs both primary and secondary packaging and labelling.

The clinical trials space is currently experiencing a shift from small molecule drugs towards biologics and, as a result, temperature-sensitive drugs are increasing the demand for reliable cold-chain clinical trial supplies management. At Clinigen, we ensure we keep up with industry trends to support even the most complex or innovative of treatments.

With input from our highly valued clients, our capable, knowledgeable team members work strategically to configure the most cost-effective and patient-compliant methods. They do this all the while ensuring absolute efficiency and accuracy supporting your global trial, which we are positive you will not find at this level of professionalism from any other clinical trial packaging provider, as over 80% of our clinical trials are multinational.

We offer clinical packaging and labelling, storage and distribution, as well as On-Demand and Direct-to-Patient packaging services, including cold chain packaging and labelling solutions. For nearly three decades we have been focused on providing our clients with innovative, flexible service options for their clinical trials; making sure our packaging and labelling services are compliant with all and any local regulations. We are readily available to cater to all of our client’s goals for every clinical trial - no matter how large or small. The Clinical Supplies Management team commits to providing every client with the most resourceful, efficient packaging and labelling services for every clinical trial.

Does your study involve a short timeline or complex packaging requirements? Check out the On-Demand Packaging and Labelling process that allows you to start your clinical trial in just a few weeks.

Clinigen has 25-plus years of clinical trial packaging and labelling experience. This assures that we are capable and ready to handle any and all changes in a qualified, effective manner, which successfully eliminates re-work and makes adaptive trials possible.

Clinical trial packaging and labelling

As your preferred clinical trial packaging and labelling service provider, we will ensure the highest level of accuracy, with meticulous inspection and QC oversight.

Unlike many other clinical trial packaging and labelling companies, our methods are built around facing all challenges head-on to prepare accurate, timely mass-pharmaceutical packaging and clinical labelling supplies for your study.

Our patient and client-driven services are built to ensure the best possible outcome for your clinical study-specific packaging and labelling needs.

All of Clinigen’s clinical packaging and labelling services are performed under cGMP and EU GMP conditions and meet 21 CFR and EU CTR (Clinical Trial Regulation) requirements.

Clinical Trial Packaging and Labelling Services

  • Primary and secondary packaging
  • Label Design, Printing, and Application
  • Patient Kit Assembly
  • Blister Packaging
  • Carding
  • Small Lot Bottling
  • High-Speed Bottling
  • Cold and frozen labelling

On-demand packaging and labelling

We recognise the packaging and labelling obstacles that you may face during your clinical trials - from time constraints to study changes that cause re-work and waste. On average, 50% of all clinical supplies that are packaged and labelled are never used.

With Clinigen’s On-Demand method, you can shorten timelines, reduce waste, and increase the flexibility of your study so as to directly tackle any packaging and labelling difficulties from the start. No more having drugs sitting at sites that aren’t enrolling patients. No more having to rework finished products with label changes.

On-Demand focuses on actual enrolment, allowing your company to start a clinical trial in just a few weeks. We recognise the urgency of time in relation to your study.

On-Demand is the packaging and labelling of clinical supplies specifically for, and immediately prior, to each shipment request. Simultaneously, we make sure your shipment request will be processed within 48 hours (for the US)- every single time.

For our European facilities, the On-Demand process is available, which allows for our EU sites to complete the request within 72 hours, including our QP release. Our team is proud to have an advantage over other clinical trial management companies in this post-Brexit world, as we have two highly established sites within the EU: Belgium and Germany.

Our On-Demand service allows you to pack and label a small number of patient kits within 5 days from request, from packaging, to release and shipment. This is a full GMP kit-packaging and on-request labelling method (which goes beyond simply applying a JIT sticker during a shipment preparation process).

This service is offered specifically for studies where the study drug is extremely limited and expensive in order to avoid drug waste.

Clinical trial label design and production

We understand the difficulties in designing and producing labels for clinical trials. This is why Clinigen offers flexible, accurate, and compliant clinical labelling precision for whatever those clinical trial label or design challenges may be.

Once we establish the logistics of your clinical trial labelling requirements, our highly efficient designers produce focused products meant to meet both the regulated and the aesthetic design your study needs.

Our highly skilled team will consistently be by your side in order to adhere to your exact protocol needs. They will provide customisable solutions that benefit the unique characteristics of your clinical labelling and production needs. This allows us to properly and professionally manage the personalised supply chain logistics of your trial.

We make sure your pharmaceutical supplies are correctly labelled and produced in a fast, efficient, and timely manner, tailored to your specific trial needs.

Our Clinical Labelling Services Include:

  • Single and multi-panel
  • Single and multi-lingual
  • Randomized and open
  • Variable text
  • 30+ languages that are fully supported
  • Sequentially numbered
  • Labels designed to maintain adhesion at
  • CRT, 2-8°C, -20°C, -70°C and -180°C
  • Code break envelopes
  • Scratch-off labels
  • Blinding laminates
  • Barcode printing
  • Coloured texts and labels
  • Logo and graphic placement
  • Booklet labels
  • Extended content labels
  • Directions for use inserts

Our in-house thermal transfer printing capabilities allow for a quick turn-around when your project has a short timeline.

Clinigen operates under cGMP compliant procedures, and each label undergoes a 200% quality inspection.

Success stories

On behalf of my team, I would like to express our sincere thanks to Clinigen for your extraordinary work and dedication. We would not have been able to meet our clinical program goal without your heroic effort.

Vice President of Technical Operations

BioPharma Company

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As a leading provider on a global scale, Clinigen is committed to delivering fully integrated logistics services to our clients. Over 80% of the studies we are supporting are multi-national and we organise shipments to 130+ countries.

Speak with a clinical trial supply services expert