Clinical Trial Support

Navigating a drug through a clinical development trajectory is one of the most difficult and expensive challenges that our clients face. At Radiomics we believe that knowledge and understanding are key to success. Our radiomics image analysis provides an array of endpoints for the evaluation and early detection of safety and efficacy of drugs, which are sensitive to the slightest treatment-induced changes. The use of this technology in Phase I and II of drug development allows our clients not only to run shorter trials requiring less patients, but also to be better informed in their decision-making process and in the optimization of the subsequent trial design. Since our radiomics endpoints are based on standard clinical images in DICOM format, they can also be used in a Phase IV setting to demonstrate the real-world efficiency of an approved treatment.

Furthermore, given the possibility to acquire similar scans from animals, Radiomics can accompany its clients during the entire drug development trajectory, starting from preclinical phases up to post-market stages, providing them with true translational tools for an optimized insight-based decision making.

It is known that not all the patients react the same way to the same treatment: some of them fail to respond to certain therapies, experience adverse events, or develop therapy resistance over time. Our sensitive treatment evaluation approach informs our clients early on in the clinical drug development trajectory about the possibility of large variabilities in treatment response. If these are present, Radiomics helps its clients to stratify the exact responders’ phenotype. Also, we have previously demonstrated that radiomics-based imaging biomarkers can accurately detect several relevant biological pathways. All this additional information can lead to an optimized patient population selection during pivotal trials, hence increasing the chance on successful market authorization. Next to this, we can also assist in the search or development of specific, potentially image-based, pre-screening tools for better patient enrolment.

Being able to identify the treatment responder phenotype in a broad population of patients is a first step in going from the traditional “one-size-fits-all” model to a fully personalized-medicine approach. At Radiomics we have developed and prospectively validated treatment-specific image-based prediction signatures for individual patient use. If our clients should require  a similar companion diagnostic tool, we offer our expertise to co-develop such solutions to assist clinicians in their patient management and follow-up,strengthening our clients position in value-based reimbursement landscape.