Beyond the typical services of an imaging CRO, Accentedge Health positions itself as an expert partner for the pharmaceutical industry. Using our proprietary radiomics analyses, combined with our clinical and therapeutic expertise, we provide insight-based decision-making solutions to optimize the clinical drug development trajectory.
Clinical Trial Support
Industry & Pharma
We can support our clients in all the different phases of clinical trials, by providing additional information on:
Disease Detection & Characterization
Traditional endpoints are known to be rather insensitive to disease progression (such as RECIST or FEV1) or to require a very long follow-up period for patients in clinical trials (exacerbation, survival,…). At Accentedge Health we help our clients getting a deeper understanding of the disease trajectory they are trying to cure, using the wealth of information embedded in the medical images collected from patients.
By identifying imaging characteristics that change as disease progresses, additional quantifiable and very sensitive endpoints related to the safety and efficacy of the treatment can be defined. This kind of research, carried out before a drug enters the clinical development trajectory, can speed up phase I and II trials.
Navigating a drug through a clinical development trajectory is one of the most difficult and expensive challenges that our clients face. At Accentedge Health 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, Accentedge Health 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.
Patient Selection & Stratification
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, Accentedge Health 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.
Prediction of Treatment Effect
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 Accentedge Health 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.