We know clinical supply
From sourcing to site delivery. Reliable, integrated, and built to adapt.
Clinical supply is a strategic function. We treat it like one.
We approach clinical supply as an extension of your development strategy — not a downstream execution task. With more than 20 years of clinical packaging and supply chain experience, combined with deep CMC expertise, we connect comparator sourcing, placebo manufacturing, packaging, labelling, QP certification, and global distribution into one coordinated supply programe.
OUR CAPABILITIES
Your Single Point of Contact. From Protocol to Site.
Every clinical supply programme we run is led by a dedicated project manager — an experienced clinical supply specialist who takes the time to understand your study design, your supply chain constraints, and your organisation before the first packaging run begins.
Our project managers are your single point of contact across all supply activities — comparator sourcing, packaging, labelling, logistics, and returns. They work in close collaboration with our operations teams and are recognised for fast, proactive response times that keep your programme moving.
What this means in practice:
- In-depth knowledge of your business, protocol, and supply chain built from day one
- All decisions made within the context of your distribution strategy, not in isolation
- Proactive identification of packaging and supply challenges before they become timeline risks
- A single escalation point across all clinical supply activities

GDP-Licensed. Globally Networked. Strategically Managed.
Comparator sourcing is one of the most complex and timeline-critical elements of modern clinical trials. Availability constraints, allocation risks, cold chain requirements, and documentation demands require active management — not reactive procurement.
We manage this complexity through a strategic sourcing approach underpinned by our GDP licence, ensuring full compliance with Good Distribution Practice requirements and complete traceability across the supply chain.

Comparator sourcing capabilities:
- Direct sourcing from wholesalers, local distributors, and qualified manufacturer networks across Europe and globally
- Central or local sourcing strategies depending on study design and site geography
- Management of availability constraints, allocation risks, and supply shortages
- Strict adherence to storage requirements and cold chain handling for temperature-sensitive products
- Batch selection, shelf-life optimisation, and complete documentation management
Blinding solutions:
- Over-encapsulation of comparator tablets or capsules to match active product appearance
- De-blistering and re-packaging for blinded kit assembly
- Re-labelling to align comparator presentation with study protocol requirements
- Integration of blinding strategy into the broader packaging and distribution plan
Matched in Every Detail. Essential to Study Integrity.
In a blinded clinical trial, the placebo is not a secondary deliverable — it is a critical component of the study design. A placebo that differs from the active product in colour, size, weight, or dissolution profile introduces observable differences that can unblind investigators or patients and compromise the validity of clinical data.
We develop and manufacture placebos that match the active product in appearance, physical characteristics, and primary packaging presentation — ensuring that no observable difference exists between active and placebo arms of your study.
Placebo manufacturing capabilities:
- Analytical services including release testing and stability studies
- Capsules and tablets across multiple formulation types
- Colour and size matched to active product strength
- Primary packaging identical to the active product
- Batch sizes from 200 to 80,000 units — scaled to clinical phase requirements

Packaging That Works for Your Protocol, Your Sites, and Your Patients.
Clinical packaging connects the drug product to the clinical site and, ultimately, to the patient. It must be compliant, practical, and designed to support the specific operational requirements of your study — not adapted from a commercial template.
Our packaging team designs and executes clinical packaging solutions across primary and secondary formats, with the flexibility to handle straightforward and complex requirements alike.

Primary packaging:
- Capsules, tablets, solutions, beads, and powders across standard and bespoke formats
- Blister packs, bottles, vials, and sachets
Secondary packaging and kit assembly:
- Patient kits designed for usability and protocol compliance
- Kit assembly aligned with randomisation scheme and dosing schedule
- Generation of randomisation lists and kit number management
Labelling:
- In-house GMP label printing on polyethylene and polyvinyl substrates, fully compliant
- Single and multi-language labels for global trials
- Booklet, wrap-around, and peel-off label formats
The Flexibility Your Global Trial Needs.
Traditional clinical labelling — where labels are printed and applied well in advance of shipment — creates inflexibility that costs time and generates waste. Country mix changes, protocol amendments, recruitment dynamic shifts, and expiry date extensions all require label updates that, in a conventional workflow, mean repackaging, waste disposal, and delay.
Our Just-in-Time (JIT) labelling approach decouples packaging from label application, keeping labels unprinted until close to the point of shipment. This delivers meaningful operational advantages for studies at any phase:
- Shorter lead times from packaging to site receipt of patient kits
- Reduced material waste — no pre-printed labels rendered obsolete by protocol or country changes
- Flexible country and language management — adapt to recruitment realities without repackaging
- Elimination of complex multi-language booklet labels in many scenarios
- Re-labelling and over-labelling for expiry date updates on already-packaged materials

Regulatory Assurance. On-Site. At Every Stage.
Qualified Person (QP) certification is a mandatory step in the release of clinical trial materials in Europe — and one that requires both deep regulatory knowledge and practical experience across dosage forms and geographies.
We have full-time, on-site QPs experienced across multiple dosage forms and clinical supply scenarios. Our QP team ensures that:
- Regulatory questions and audit requests are handled quickly and with full traceability
- Products meet your regulatory commitments in every territory
- Batch certification is conducted with full understanding of the manufacturing and supply chain history
- Processes and documentation are harmonised across your programme

From Our Facility to Your Clinical Site — Controlled, Tracked, and On Time.
We provide GMP-compliant storage and global distribution for clinical trial materials, with full inventory and expiry visibility and the operational agility to respond to the unpredictable realities of clinical trial execution.
Storage:
- Controlled ambient (15–25°C) and refrigerated (2–8°C) conditions
- Continuous temperature monitoring and deviation management
Distribution:
- Temperature-controlled distribution to clinical sites within the EU and for global export
- Door-to-door delivery of IMP to clinical sites and depots
- On-demand shipment capability with a target lead time of one week
- Inventory management and expiry tracking to prevent supply interruptions

End-to-End Accountability — Including the End.
Clinical supply accountability does not end at site delivery. Ardena manages the full returns and destruction cycle, ensuring that unused and returned IMP is handled with the same compliance and traceability as the outbound supply chain.
- Materials gathering and consolidated return shipments from multiple clinical sites
- Return shipment management and in-transit condition monitoring
- Reconciliation of returned IMPs and ancillary materials
- Certificate of destruction issued upon completion

Supply and Science, Coordinated from Day One.
Sampling kit design sits at the interface of clinical supply and bioanalytical science — and when these two functions are not aligned, the result is handling errors, protocol deviations, and compromised sample data.
We design and supply sampling kits and ancillary study materials in direct coordination with our bioanalytical capabilities — ensuring that kit design, sample handling instructions, storage conditions, and chain-of-custody documentation are aligned with the analytical methods processing the samples.
- Consistent sampling kits across all clinical sites
- Design aligned with bioanalytical workflows from the outset
- Combined shipment of IMP and sampling materials where operationally appropriate
- Simplified site-level procedures to reduce investigator burden and protocol deviations

Why clients trust us with their clinical supply.
The Clinical Supply Partner That Understands Your Development Programme
| 20+ years of experience | Bridging CMC development with clinical trial execution across phases I to III for IMPs and IVPs |
| GDP-licensed | Full Good Distribution Practice compliance for comparator sourcing and distribution |
| On-site QPs | Experienced Qualified Persons available for batch certification across dosage forms and geographies |
| Just-in-Time labelling | Operational flexibility that reduces waste, compresses timelines, and adapts to your recruitment reality |
| Phase-appropriate solutions | Clinical Phases I through III — batch sizes and service models scaled to where you are in development |
| Single point of contact | One experienced project manager across all supply activities, with fast response times |
| Integrated with IMP manufacturing | Clinical supply connected to the team that developed and manufactured your IMP — no handoff gap |
| Small molecule and biologic | Licensed for secondary packaging and labelling across both modalities |
| Excellent audit record | High-quality GMP services with consistently strong audit outcomes |
Related Resources
Our clinical supply team members share their deep, scientific understanding and insights.
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Info sheets
Secondary Packaging Built for Complex Clinical Trials
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Case studies
Enabling Complex Phase IIa Dosing Through Flexible Clinical Packaging Design
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Insights
How to save significantly on early-phase clinical supply logistics?
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Expert Q&A
Strategies for Effective Cold Chain Packaging and Labelling
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Info sheets
Timely Clinical Trial Material Services
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