Radiopharmaceutical Trials in Latin America: Designing Logistics Around Half-Life, Handoffs, and Site Readiness

Radiopharmaceutical and radioligand therapies are expanding rapidly, and many sponsors are now looking to Latin America for faster startup, experienced investigators, and access to oncology patient populations. But radiopharma is unforgiving: the physics of radioactive decay turns logistics into a core part of trial design.

This article focuses on an external knowledge gap we often see in early-stage planning: teams design protocols as if supply behaves like conventional biologics. In radiopharma, half-life, handoffs, and site readiness should be treated as first-order design constraints—especially when operating across borders.

1) Start with the supply chain reality: isotope generation is often the bottleneck

A common misconception is that the primary constraint in radiotherapeutics is clinical site availability. In reality, the historically limiting step is often radioisotope generation. Many isotopes rely on specialized production routes and third-party suppliers, and the manufacturing ecosystem is still evolving.

Planning implication for Latin America: before selecting countries and sites, lock down a realistic isotope supply and production model, including contingency plans for supplier outages and regulatory delays in cross-border transport.

2) Choose a manufacturing model that matches isotope half-life

Different isotopes drive different logistics architectures:

• Longer-lived isotopes (e.g., Lu-177, Ac-225): may support more centralized radiolabeling and batch release models.
• Shorter-lived isotopes (e.g., Pb-212 ~10.6 hours): push you toward decentralized generation and local radiolabeling close to the patient.

In Latin America, this choice should also account for: (1) availability of qualified nuclear medicine infrastructure, (2) cross-border shipping routes, and (3) the maturity of local partners (CDMOs, radiopharmacies, and specialized couriers).

3) Minimize handoffs: every transfer adds time, risk, and decay

Radiopharma supply chains can involve multiple players exchanging radioactive intermediates or final products before patient administration. Each handoff introduces:

• Time loss (and therefore activity loss due to decay)
• Quality risk (chain-of-custody, temperature and shielding controls, documentation)
• Regulatory friction (hazmat paperwork, customs timing, transport authorizations)

Design rule: whenever feasible, reduce the number of handoffs by using more integrated partners or regional hub-and-spoke models that shorten shipping legs and standardize handling.

4) Make “site readiness” a trial endpoint for operations

Hospitals and treatment centers play a critical role in final handling, storage, and administration. For radiopharma studies, site readiness is not a checkbox—it’s an operational capability. A practical readiness assessment should include:

• Receiving procedures: trained staff, radiation safety workflows, and documentation discipline.
• Storage and shielding: compliant storage conditions, monitoring, and access controls.
• Administration capability: dosing accuracy, decay-aware scheduling, and incident response plans.
• Waste management: procedures for radioactive waste and contaminated materials.

In multi-site Latin America trials, variability in readiness is common. Sponsors should plan to standardize training, templates, and QA checks, and to run an early “dry run” shipment where possible.

5) Logistics is not an afterthought—write it into the protocol

Many protocols focus heavily on clinical endpoints and adverse event reporting but leave logistics to operational teams late in the process. A stronger approach is to embed decay-aware operational constraints into the protocol and trial execution plan, such as:

• Scheduling windows for dosing relative to manufacturing time and transport time.
• Backup visit procedures if shipments are delayed (including re-dosing rules where appropriate).
• Defined responsibilities across isotope suppliers, CDMOs, couriers, and sites.

This reduces protocol deviations and avoids the “logistics-driven” screen failures that can quietly erode trial power.

6) A practical Latin America framework: regional hubs + local radiolabeling where needed

One pragmatic way to manage Latin America complexity is a regional hub-and-spoke approach:

• Hub(s): centralized or regional sites with strong infrastructure for radiolabeling and dose formulation.
• Spokes: patient-facing treatment sites within predictable transport time windows.

For very short half-life products, the hub may need to be in-country, or you may need local generators and radiolabeling capability. For longer half-life products, regional hubs can reduce redundancy and still meet dosing schedules.

FAQ

What is the single biggest logistics factor in radiopharmaceutical trials?

Half-life. It drives manufacturing model, transport timing, number of handoffs, and site scheduling constraints.

Can radiopharmaceutical trials be run across multiple Latin America countries?

Yes, but the supply chain must be designed explicitly for cross-border transport, regulatory requirements for radioactive materials, and realistic customs timelines.

Should sponsors build in-house radiolabeling capabilities?

It depends on scale, isotope type, and strategic priorities. Many sponsors partner with CDMOs and specialized providers to avoid costly infrastructure investments while gaining expertise and established safety systems.

Bottom line: radiopharmaceutical trials succeed when operations are designed around physics. In Latin America, sponsors who align isotope choice, manufacturing model, handoffs, and site readiness can unlock the region’s speed advantages without compromising safety or data integrity.