Clinical supply

Clinical supply

We take care of your clinical logistics with a range of GMP-compliant packaging, labeling and supply services that ensure reliable delivery of ready-to-use products and materials to your trial sites.

Flexible. Agile. Reliable. We work diligently to your timescales

Ensuring stable supply

Ensuring sites taking part in a clinical development program have the supplies they need at the right time is vital to running an effective, efficient trial. We tailor and optimize packaging, labeling and supply strategies to meet your stringent timelines and study design.

Ardena has more than 20 years of experience in the management of biological samples from clinical trials, uniquely offering CDMO and bioanalytical services in combination with the production and supply of biosample collection kits.

Packaging

Packaging

We provide a full range of bespoke packaging services covering primary and secondary packaging and kit assembly for a wide range of container types, offering carefully crafted packaging services to fit the specific protocol of your trial.

Our clinical packaging team helps you deliver trial materials to the right site at the right time.

  • Primary packaging of the in-house or externally produced drug product (capsules, tablets, …) in different types of containers ((cold or thermoformable blisters, bottles, tubes, sachets). Capacity to handle highly potent drugs and controlled substances.
  • Secondary packaging including patient kit assembly and labeling ready for use in the clinic
  • Use of tamperproof primary and secondary packaging materials

Labeling

Labeling

Whatever your labeling challenges, we meet your clinical protocol requirements with customizable solutions. We work with our clients to optimize product packaging and label designs and can assemble patient kits and provide comprehensive kit labeling printing services.

  • Dedicated rooms for label printing and packaging activities
  • Preparation and translation of multi-language label text
  • Label (printing) activities with single layer labels, booklet labels, peel-off, taking into account variable fields (including patient or kit numbers) or special requests
  • Relabeling according to expiry date extensions
  • Just-in-time labeling

Clinical trial supply/logistics

Clinical trial supply/logistics

Ardena has logistics expertise in all types of early clinical development, from multi-center Phase I to Phase IIa for a huge range of therapeutic areas, including rare diseases, orphan diseases and oncology.

Our seamless approach is designed to provide visit kits to clinical sites in such a way as to eliminate the risk of sample mishandling, combining drug product and sample kit logistics services.

This can be complemented with unique bioanalytical services that offer a visit- and patient-independent sample collection and registration system ensuring a minimum number of queries. Samples are registered in a dedicated Clinical Trial Management System (Labware). Not only does the system track samples, it also takes care of active follow-up of biosample collection kit distribution, expiration and communication regarding sample queries.

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  • Temperature-controlled storage of primary and secondary packaged materials at 15 – 25 °C, 2 – 8 °C and -20 °C.
  • Team of five trained in IATA packing instructions
  • Randomization of the supplies, blinding & un-blinding services for single- and double-blinded studies
  • Rescue medication repackaging and labeling for clinical trial use
  • Comparator sourcing, release, re-packaging and labeling for clinical trial use
  • Preparing of kits with and concomitant shipping of consumables needed to administer IMPs
  • Temperature-controlled shipments and deviation monitoring
  • Returns reconciliation and destruction
  • QP release services

Related resources

Our clinical supply team members share their deep, scientific understanding and insights.

Your molecule, your journey, our mission.

Get in touch to see how we can craft your path to the clinic with dedicated capabilities.

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CMC regulatory services

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