Yet unlocking this potential depends on the supply chains behind the science.

With the high costs and increasing complexity that advanced therapies bring, particularly those demanding end-to-end cryogenic or ultra-low temperature management, supply chain failure is quickly becoming a leading risk factor in modern clinical trials.

To uphold patient safety and keep trial timelines on track, sponsors must prioritise optimised, compliant, and patient-centric clinical supply chains from the outset.

For many sponsors of advanced therapy trials, robust cryogenic supply chain management is a core enabler of trial success. And getting it right requires deliberate, early planning. Here’s how to get started…

Know the difference

Cryogenic supply chains demand a completely different level of precision. Materials must be maintained at ultralow temperatures, often ≤-150°C, using specialised packaging, liquid nitrogen vapour phase systems, and rigorously validated shippers. There is very little tolerance for delay or deviation, and traditional buffer stock strategies don’t apply when managing small batch or patient-specific material.

Advanced therapies are particularly vulnerable. Many are irreplaceable – patient-derived, bespoke, and biologically fragile. A single handling error can render material unusable, meaning lost doses, missed treatment windows, and patients who can no longer participate.

Recognising these distinctions early and designing your supply chain infrastructure around them rather than retrofitting standard models, is the foundation of a cryogenic supply chain that’s built to protect both product and patient.

Figure out your failure points

The most common supply chain failure points include breaks in temperature integrity during transit, limited visibility once material leaves a single provider’s control, and inadequate contingency planning for returns, resupply, or reshipment.

Failures can spiral quickly. Missed dosing can trigger site shutdowns and protocol deviations. Material loss can force repeat manufacturing and expedited rescue shipments. Delays can lead to resupply, reconsenting, and re-enrolment; all of which can extend timelines, escalate costs, and negatively impact patients.

Mapping these failure points at protocol stage, with precision and honesty about where gaps exist, gives sponsors the opportunity to build contingencies into the supply chain from the outset. It also makes a compelling case for end-to-end ownership over fragmented, multi-vendor models.

Prioritise integration

For cryogenic material, every handoff between vendors is a point of exposure that increases the risk of temperature excursions.  

Almac’s Cryogenic Service Solution is purpose-built to overcome the risk of fragmented supply chains. In our state-of-the-art, fully contained cGMP suite in Durham, NC, three segregated processing rooms safely handle, package, and label advanced therapies under cryogenic conditions.

Cutting-edge liquid nitrogen vapour phase freezers offer -190°C top box capability, with capacity for 42,000 vials and 100% redundancy to maximise product integrity. A 24/7 building management system provides continuous monitoring of both vessels and environmental conditions, while custom storage solutions and segmented racks accommodate client-specific requirements.

From storage through to distribution, our robust cryogenic shipping service utilises specialist vapour and validated shippers to guarantee product integrity throughout transit and provide an unbroken chain of custody from production line to patient. Every movement documented, every condition verified, and full traceability provided throughout.

When evaluating your supply chain model, ask whether your current set-up can offer this same level of unbroken oversight. If it can’t, it’s time to make integration the priority.

Plan early

Building cryogenic supply chain planning into protocol design from the outset is a frequently overlooked, yet incredibly important step.

Early alignment between manufacturing, supply, and clinical operations teams allows contingency planning to be embedded from day one, covering delays, returns, and global variability.

Almac’s Cryogenic Service Solution brings 30 years of experience, global infrastructure, and expert people, processes, and technology to this challenge, including Almac Adapt, a demand-led, just-in-time manufacturing solution designed to facilitate lean production. Custom storage solutions ensure the model flexes to meet client-specific needs as trials scale across regions and patient volumes.

Essentially, the earlier cryogenic supply chain planning begins, the greater the opportunity to anticipate risk, build in contingency, and design a model that is shaped around your protocol from the ground up.

Discover more about our Cryogenic Service Solution

The post How to build a robust cryogenic clinical trial supply chain appeared first on Clinical Services.

Almac Adapt™, Almac Clinical Services’ JTM solution, enables late-stage customisation of clinical kits once demand signals are received, allowing supply to be aligned more closely with real-world patient and site needs. It’s a proven tool for studies involving personalised therapies, uncertain enrolment patterns or constrained drug supply – helping to boost efficiency, reduce risk, control cost, and centre patients in the clinical trial operation.

But before you embark on your demand-led manufacturing journey, there are several factors to consider (and myths to dispel).

Read on to discover more…

Cost considerations

JTM is sometimes viewed as a higher-cost option due to the smaller, more frequent operations involved. From a traditional manufacturing perspective, this can appear to limit economies of scale.

However, when assessed across the full clinical supply lifecycle, JTM can help offset initial costs by reducing overproduction, minimising excess overage and limiting returns, destruction and accountability activity.

In many cases, these efficiencies contribute to a more balanced overall cost profile, particularly for studies with variable or uncertain demand.

Applicability across study sizes

JTM is well suited to smaller or early-phase studies, especially those involving niche indications or targeted patient populations where forecasting demand can be challenging.

However, its value extends beyond these settings. In larger trials, JTM can play a critical role during early enrolment, when recruitment rates and global demand are still evolving, helping sponsors manage uncertainty and protect investigational medicinal product (IMP). As enrolment stabilises, sponsors can choose to transition to batch manufacturing for later treatment cycles, creating a flexible, hybrid supply model that evolves alongside the study.

Relevance across therapeutic areas

While JTM is often associated with rare disease and cell and gene therapies, its benefits extend beyond any single therapeutic area. The ability to respond quickly to changing demand, while preserving drug product is relevant to a wide range of studies.

Trials in oncology, immunotherapy and investigator-initiated research, for example, often face enrolment variability or limited drug availability – conditions where an on-demand approach can provide meaningful support.

Compatibility with IRT systems

JTM can be successfully integrated into studies that use interactive response technology (IRT), as well as those managed through manual processes.

Supplies manufactured through a JTM model are released into IRT systems using the same standard metadata as batch-produced supplies. This allows sponsors to maintain familiar workflows, while benefiting from a pull-through supply strategy that supports waste reduction and inventory optimisation.

Use across different IMP types

While JTM is often associated with biologics and advanced therapies, it is not limited to them. It can be applied across a range of IMP formats, including solid oral dose medications.

When demand cannot be predicted with confidence, an on-demand approach offers flexibility regardless of compound type, helping sponsors maintain continuity of supply while avoiding unnecessary production runs or re-work.

Interested in exploring how JTM can support your clinical trial? Speak to us about Almac Adapt™.

The post Rethinking Just in Time Manufacturing for Clinical Trials appeared first on Clinical Services.

In this episode of the Fierce Life Sciences podcast, Olive McCormick, Director of Quality at Almac Clinical Services, shares expert insight on navigating the new Clinical Trial Regulation in the United Kingdom. Olive breaks down what the updated framework means for sponsors, the practical implications for trial delivery, and how sponsors can adapt with confidence in a rapidly evolving regulatory landscape.

Ready to dive deeper into the discussion?

Listen to the full episode now

The post Podcast: Navigating the new Clinical Trial Regulation in the United Kingdom (UK) appeared first on Clinical Services.

Episode 1: From Concept to Delivery: Navigating the Challenges of Clinical Trial Set-Up and Maintenance To Optimize Performance

In a fiercely competitive drug development landscape, traditional large-scale players are falling behind smaller and more agile firms. Emerging biopharma companies now need a lot of support and education to meet aggressive timelines. Learn how to navigate the challenges of clinical trial set-up and maintenance.

Listen to episode 1 now

Episode 2: Planning for Success: Embracing Strategic Solutions to Boost Flexibility, Reduce Waste, and Empower Patient-Centric Clinical Trials

Once study requirements are complete, emerging biopharma companies must tackle unique project management challenges. Varying, complex regulatory timelines and differing drug shipment requirements by country complicate the process. Discover strategic solutions to bring trials in on time and on budget in episode 2 of our three-part podcast series.

Listen to episode 2 now

Episode 3: Mastering Clinical Supply: How Clinical Supply Managers Turn Challenges into Solutions

As the client’s advocate, the clinical supply manager (CSM) navigates the complexities of supply management, from drug receipt to final disposition, ensuring trials stay on track despite evolving challenges. In episode 3 of our three-part podcast series, dive into the vital role of CSMs in the execution of clinical trials.

Listen to episode 3 now

The post 3-Part Podcast Series: Behind the Breakthroughs: How Almac Powers Clinical Trial Success with Care appeared first on Clinical Services.

Cut to an FDA clinical site audit. While reviewing the site storage temperature logs, the auditor frowns – their demeanour shifts. They’ve just uncovered 12 excursions. Excursions that have been left unreported for a period of two years. Excursions that could have compromised drug products, patient safety and research validity.

You’re stunned. You ask, “how could this happen?” Afterall, you have a robust process to manage site compliance, right? As you piece together where it went wrong and uncover the extent of the problem, one thing’s clear: this can’t happen again.

So what went wrong?

This story isn’t a work of fiction. It happened in the real world. But how did multiple temperature excursions go unreported for two years? Well, like most sponsors, this large pharma company utilised a manual process to manage site compliance.

While Almac manages adjudication for transit and site-based excursions, via the TempEZ platform, the CRO was responsible for ensuring sites complied with the approved reporting process. Despite regular visits, the CRA failed to detect the 12 unreported excursions.

Factors that contributed to this outcome included:

• Retrospective review – the CRA would visit sites periodically and review compliance retrospectively, making it difficult to catch instances of non-compliance in a timely manner.
• Broad remit – the CRA was responsible for more than just temperature management and would divide their time and focus at clinical sites between multiple functions and processes. This made it easier for the unreported excursions to go unnoticed for so long.

Sarah McAliskey, Temperature Services Manager at Almac Clinical Services, explains: “As you move through the clinical supply chain, the likelihood of a temperature excursion occurring increases, while the detectability plumets. Site storage compliance is a real blind spot for sponsors and demands proactive management to mitigate risk and ensure site excursions are adjudicated in a timely manner.

“Unfortunately, for this client, the flaws in their manual approach caused unreported excursions to go unnoticed for years, which could have resulted in study drug being administered to a patient that was stored outside of the labelled conditions. Not only did this sponsor need to quickly establish if drugs that should have been rejected were inadvertently assigned to patients, they needed to ensure it couldn’t happen again.”

Uncovering the truth

Under pressure from the FDA, the sponsor reported the 12 missed excursions to Almac, who prioritised the project and fast-tracked the review process. A team of dedicated temperature experts meticulously sifted through a significant amount of data . This included looking at kits in timeline order to assess the cumulative impact and whether they had been subject to more than one excursion. Thorough, expert adjudication was completed in just 24 hours and determined that no kits involved in the unreported excursion events were classed as needing to be rejected.

Although it demanded urgent attention and significant resource, the sponsor was able to demonstrate that the safety and efficacy of all compromised supplies was upheld. However, this scenario could have unfolded very differently, with significant patient risk and regulatory impact.

Picking a better path

Determined to prevent a repeat occurrence, the sponsor instructed Almac to take over site compliance management. This would involve dedicated focus and monthly reviews of site temperature logs – drastically reducing the window of risk for excursions to occur and go unreported. Temperature data logs would also be stored in the Site Compliance module of TempEZ, increasing visibility of temperature data and improving the chances of detecting unreported site storage excursions faster, while minimising risk to patients.

Putting patients first

Sarah comments: “We proactively collect temperature data each month and harnesses the latest technology to create better visibility over site compliance, track performance, assess trends and flag issues. Because we have eyes on the data sooner, we can act faster to increase compliance and ensure excursions are identified and reported quickly and effectively.

“This new approach will help to avoid any regulatory fallout following site audits in the future and ensure patient safety remains at the heart of this sponsor’s clinical trial.”

The lesson from this cautionary tale?

You may think you have a robust process for managing site compliance for your temperature sensitive supplies but without a dedicated, pro-active process for keeping sites in check, you too could fall victim to site-based temperature excursions slipping through the cracks.

Need to get on top of site compliance? Speak to us.

The post Got a robust process for managing site storage temperature compliance? This sponsor thought they did too… appeared first on Clinical Services.