Non-Clinical studies
Non-clinical studies are an essential part of the development of novel radiotracers and theranostics.
Increasing regulatory focus on the scientific relevance and translational justification of preclinical data means that careful consideration must be given to study design, model selection, and the overall impact of generated data on the downstream clinical development pathway.
Whether evaluating basic proof-of-principle biodistribution, tissue pharmacology, dosimetry or therapeutic efficacy, CITRAS provides expert support in both the design and critical review of non-clinical programmes.
Designing Preclinical Programmes That Enable Clinical Translation
Where required, CITRAS can recommend AAALAC accredited partners and can assist with:
Study design
Site selection (AAALAC accredited sites only)
Reqisite preclinical studies to enable clinical translation
Scientific review and support
Tech transfer and method development support
Trouble shooting and root cause analysis
Data interpretation
Report review
Our Services
Discuss Your Radiopharmaceutical Programme with Our Senior Team
Independent expertise in radiochemistry, imaging and regulatory strategy - tailored to your development stage.