How do you run a first-in-human radiopharmaceutical (theranostic) trial?

Radiopharmaceutical (theranostic) first-in-human trials require nuclear-medicine-capable sites, dosimetry, and supply-chain timing built around short isotope half-lives (Lu-177, Ac-225, Ga-68). bioaccess® runs them with U.S. regulatory anchoring (FDA Pre-Sub, IND) and Latin American execution — 40% faster and ~30% lower cost.

From the Global Trial Accelerators™ podcast (hosted by bioaccess®), with Dr. Jason Hurt of Theragnostic Insights: watch the episode.

Why radiopharmaceutical trials need a specialized setup

• Nuclear-medicine-capable sites with radiation licensing and hot-lab / radiopharmacy handling
• Dosimetry and PET/SPECT imaging to characterize biodistribution and absorbed dose
• Supply-chain timing built around isotope half-lives — Lu-177 (~6.6 days) ships; Ga-68 (~68 min) and Ac-225 need on-site or regional generation
• U.S. regulatory anchoring (FDA Pre-Sub, IND) so the data supports the intended pathway
• Latin American execution for 40% faster timelines and ~30% lower per-patient cost

Frequently asked questions

What is a radiopharmaceutical (theranostic) clinical trial?

A radiopharmaceutical trial studies a drug that carries a radioactive isotope to diagnose or treat disease — often a theranostic pair that images and treats the same target. First-in-human studies assess safety, biodistribution, dosimetry, and early efficacy.

Does the FDA accept radiopharmaceutical data generated in Latin America?

Yes — under 21 CFR 312.120 (drugs/biologics) and 21 CFR 812.28 (device-paired diagnostics) when the study meets ICH E6 GCP and the FDA can validate the data.

Which isotopes does bioaccess® support?

Lu-177, Ac-225, and Ga-68 radioligand and theranostic programs, with dedicated nuclear-medicine sites across the Latin American network.

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