How multicentre diagnostic studies can manage isotope supply, manufacturing, and logistics constraints under tight timelines
In radiopharmaceutical development, a study’s timeline is often only as strong as the supply chain supporting it. Multicentre diagnostic studies that depend on short half-life isotopes tend to encounter a recurring set of challenges: single-source isotope dependencies, ongoing technology transfer between manufacturing partners, and fixed clinical timelines that leave limited room for delay.
In nuclear medicine, “study start-up” involves much more than regulatory approvals. A large part of the operational reality is shaped by the physics of isotope decay. With a short half-life product, the margin for delay is limited: each radioactive decay progressively reduces the activity available for patient administration after manufacture, so manufacturing release, transport that complies with applicable Class 7 radioactive-material requirements, and patient imaging windows generally need to be carefully synchronised. In practice, operational planning and clinical execution become closely connected.
The challenge of single-source supply
When a study depends on isotopes with a short half-life, the time that passes after manufacturing can gradually reduce the product’s usable activity. If the isotope is produced at a single global location, the associated logistics may be more sensitive to disruption: an additional transport leg, a customs delay, or a flight cancellation can increase the risk of a wasted dose or a missed imaging window.
Consider an anonymised example. A planned multicentre diagnostic radiopharmaceutical trial is supported by a single global isotope supplier, while technology transfer to additional manufacturing partners is still in progress. In situations like this, waiting for the full rollout of new manufacturing sites can increase the risk of a lengthy delay, whereas starting a trial too early — without a plan for long-distance distribution — can raise the risk of product waste. Because neither extreme is ideal, teams often look for an approach that balances the two.
In practice, such a study can benefit from multiple production locations. This is not only a manufacturing preference; it may also be a clinical operations requirement. Regional production capacity can help bring manufacturing closer to trial sites, support the dosing schedule, reduce transport burden, and improve reliability.
A short half-life reshapes much of the planning: manufacturing, shipment timing, and patient scheduling generally need to be aligned from the outset.
An “operational bridge” approach
One way to protect a sponsor’s timeline is to move away from a strictly linear planning model toward what can be described as an “operational bridge.” Rather than treating manufacturing expansion as a secondary, post-launch detail, it is integrated into clinical execution from the start.
For example, a controlled, expedited supply pathway from the original global source can allow a trial to begin on schedule and dose the first patients while a broader production network is still being validated. In parallel, technology transfer at regional sites can be actively accelerated as part of the core start-up plan, rather than simply monitored. As a trial’s geographic footprint grows, manufacturing capacity that moves closer to patients can help shorten the effective “logistics leg” and reduce overall study risk.
The role of centralised oversight
Coordination is often one of the more demanding aspects of these complex trials. When the manufacturing site, the logistics provider, and the clinical site operate in silos, the risk of insufficient usable activity when the product reaches the clinical site can increase.
A centralised model that connects supply planning directly to site scheduling can help address this. In this setting, operational discipline effectively becomes part of clinical delivery: manufacturing releases, Class 7-compliant transport, and patient enrolment windows are synchronised as closely as possible. If a patient’s schedule shifts while a dose is already in transit, the dose may be lost; if a dose is ready but the site is not, the opportunity can be missed. In a short half-life environment, managing these day-to-day realities helps reduce fragmented decision-making.
A strategic blueprint for sponsors
For sponsors moving into diagnostic radiopharmaceuticals, one useful takeaway is that CMC planning and clinical operations are closely connected. Several considerations are worth addressing well before the first patient is screened:
- Geographic mapping: aligning manufacturing capacity with patient clusters can help minimise transport windows.
- Integrated timelines: treating CMO technology transfer as a milestone within the clinical plan, rather than a separate workstream.
- Class 7 readiness: planning for strict Class 7 transport requirements and country-specific shipment protocols from an early stage.
- Centralised command: using a single oversight model to connect enrolment, logistics, and issue escalation.
- Sustainability: ensuring the model remains economically viable when scaled across multiple regions.
The ability to connect these elements can be an important factor in whether a trial launches on schedule and stays on track. More broadly, nuclear medicine is an area where operational discipline can meaningfully support development, and where coordinated regulatory, clinical, manufacturing, and logistics planning often makes a difference in delivering complex radiopharmaceutical trials.
This article was contributed by Axcellant, a global contract research organisation headquartered in Warsaw, Poland. The company provides clinical research and imaging services for nuclear-medicine and radiopharmaceutical studies, including first-in-human and later-phase programmes across oncology, cardiology, neurology and rare diseases. Its services support studies conducted under applicable FDA, EMA and national regulatory requirements.
Contributor disclosure: This article was supplied by Axcellant and reflects the contributor’s professional experience in radiopharmaceutical clinical-trial operations. Open MedScience has edited the article for clarity and scientific presentation.
