Candidate Selection and Chemistry Development
Designing Preclinical Programmes That Enable Clinical Translation
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.
Regulatory-Relevant Study Design
Regulators increasingly expect:
Scientifically justified study rationale
Appropriate species and disease model selection
Clear translational linkage to intended clinical use
Robust statistical and analytical planning
Data that meaningfully supports IND/IMP submissions
Poorly designed studies can introduce delay, increase cost and generate non-actionable data.
CITRAS ensures that non-clinical investment directly supports regulatory and clinical progression.
Areas of Support
Study design strategy
Selection of AAALAC-accredited sites
Definition of requisite preclinical studies to enable clinical translation
Scientific review and protocol optimisation
Technology transfer and method development support
Troubleshooting and root cause analysis
Data interpretation
Report review and regulatory alignment
Where required, CITRAS can recommend and coordinate with experienced global partners to ensure execution meets both scientific and regulatory standards.
Discuss Your Radiopharmaceutical Programme with Our Senior Team
Independent expertise in radiochemistry, imaging and regulatory strategy - tailored to your development stage.
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