White Paper

A Guide On Successfully Managing An AME Clinical Trial

Source: Worldwide Clinical Trials
Clinical Development

Despite the large existing market for AME studies, why is it that so few CROs in the United States are able to perform them? It can be hard to find an AME partner because for CROs, the necessary setup is time consuming, labor intensive, and expensive.

To conduct AME studies, a CRO must have a radiation safety officer (RSO) experienced in clinical research trial activities and processes. It must also secure and maintain the appropriate license to handle radioactive materials. This licensure generally involves one or more federal, state, and local governmental agencies. CROs are required to have the proper standard operating procedures (SOPs) and training procedures in place, and these are reviewed by the relevant authorities for approval in specific radioisotopes, such as carbon-14 and/or tritium.

Many clinical pharmacology units (CPUs) — and their associated laboratories — either don’t have the space to devote to
a separate radioactive area (dedicated space for dose preparation, dose administration, subject confinement, and sample
collection) or prefer not to undertake the rigorous training necessary for handling radioactive materials safely. Finding a partner to perform your AME studies in a reasonable time frame, let alone one with an excellent track record, may be a challenge.

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