Why Tracer?

Phase 0: Fastest In-Human trials

Imaging CRO accelerating decisions by imaging drug binding

Phase 0 explained
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Imaging CRO specialized in Phase 0 first-in-human clinical trials

At TRACER we are specialized in first-in-human studies with the use of nuclear and optical molecular imaging techniques.

By labeling an antibody, small molecule, peptide, nanoparticle, protein, or any other compound of interest with a fluorescent dye or a radionuclide, fast in human data can be obtained with an indication of the potential efficacy of the novel drug. As an imaging CRO we provide imaging and clinical services. The Phase 0 clinical trial can be conducted before the classical phase 1-3 clinical trials. This can lead to a more efficient and less costly drug development process.

Imaging CRO for drug developers

We assist our sponsors in the labeling of their lead compounds and execute first-in-human studies to visualize and quantify the biodistribution and pharmacokinetics of the compound. With the information obtained from this clinical trial, a “ go/no-go” decision can be made before the compound proceeds to the next phase in clinical development where costs are larger and time is valuable.

Early in-human studies are approved by the EMA and FDA through the so-called principle of microdosing. It allows you to often skip (large) animal models and go straight into the patient population.



FDA Accelerated Approval Program

Prof. Go van Dam, MD, PhD
Targeted optical fluorescence imaging: a meta‑narrative review and future perspectives.
Schouw, H. M., Huisman, L. A., Janssen, Y. F., Slart, R. H. J. A., Borra, R. J. H., Willemsen, A. T. M., Brouwers, A. H., van Dijl, J. M., Dierckx, R. A., van Dam, G. M., Szymanski, W., Boersma, H. H., Kruijff, S. European Journal Of Nuclear Medicine And Molecular Imaging. doi: 10.1007/s00259-021-05504-y

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