A Vision for Imaging CROs

Pharma Tech Outlook: Pharma Tech Magazine

A Vision for Imaging CROs

Mr. Hiroaki Suzuki, Director, MicronMr. Hiroaki Suzuki, Director,Micron

In the last 10 years, medical imaging has been attracting attention as objective endpoints in clinical trials. These techniques have been used as surrogate endpoints in clinical trials for various target diseases.

At the same time, modality represented by CT, MRI, and PET scan and computer systems have developed remarkably. These developments have given a new ability to find important clinical information that was previously undetectable.

The word Radiomics was also coined.

Radiologists in nuclear medicine advocated the importance of diagnosis and treatment and created the term Theranostics. As the names of diseases are subdivided, we must urgently validate not only treatments but also clinical outcomes.

Micron is developing imaging biomarkers.

Our Current Mission as an Imaging CRO
The outsourcing of clinical trials from pharmaceutical companies to Clinical Research Organizations (CROs) has been expanding, and medical imaging is in the same situation. Many clinical trials using medical images are being conducted, and our missions and opportunities are increasing.
The role of the imaging CRO is to promote clinical trials, such as kick-off meetings, training, facility selection, image collection, quality inspection, analysis, and so on.

A factor that hinders test promotion is a complex process. The cost is also a bottleneck. We believe that the reason is that there is a large gap between medical practice imaging process standards and trial-specific imaging process standards.
Now that we are conducting 100% QC on imaging scans, the idea of a risk-based approach is of primary importance.

Micron has developed a system called i-Boarding which can support imaging studies and perform risk analysis on a facility-by-facility basis.
Micron is launching a new method of monitoring facilities.

Our Vision as an Integrated Imaging Company

In the near future, the process will be easier and more efficient.

AI and CAD can help reduce our tasks, and many processes will become automated. When standardization of diagnostic imaging in routine practice is realized, there will be no gap with clinical trial standards. Eventually, our tasks will be consistently reduced. In the next step, we have to think about how to handle big data that comes from routine practice. Micron plans to build a database integrated with Personal Health Record (PHR) and ePRO/eCOA, and then the client can use data set as real-world data.

These databases will play an important role as patient-centric medicine becomes mainstream. We will not only treat but also validate clinical outcomes. Imaging biomarkers will be used in various cases in the medical field. For example, patient triage, disease detection, treatment method selection, and effect prediction can be considered. Micron has extensive clinical trial experience and we can create innovative software as medical devices (SaMD).
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