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Irene Mayorga, Clinical Trial Manager from Quibim discusses the emergence of biomarkers in clinical trials and how this will affect medical breakthroughs in the near future.

One of the more interesting things discussed with Quibim’s Clinical Trial Manager was the sophisticated process of analyzing images such as brain and lung scans with proprietary software that is then easily accessible by Sites and CRO’s alike through their web browsers.  Streamlining the receipt of the image scans from the various vendors across the globe, Quibim provides results and analysis as well as post processing of images and re-uploading the results to the Site/CRO portal.

Quibim is able to advance post process the images through quantifiable biomarkers, all in real time with simple access for the Sponsor/CRO/Trial Sites.  Biomarkers are important to analyze because they provide real time analytics to Sponsors who can analyze the process of the trial in real time.  Furthermore, the data being collected is added to the risk based monitoring components for any given trial that requires image results.  Study timelines can be reduced and save Sponsors millions of dollars per clinical trial due to these real time result and biomarker analysis.  Alternatively, clinical studies can be adapted in real time to enhance the safety profile of the subjects, or to manipulate the dosage of the investigational product when appropriate.

Quibim’s technology can apply to lung, bone, liver and other forms of cancer associated tumors due to the progression or regression of a particular tumor, again through biomarker analysis utilizing micro architecture analysis.  Allowing for virtual biopsies, as an example, liver tumors can be analyzed with greater precision and minimal invasiveness to study participants.  This has applications outside of clinical research as well, with the ability to save insurance companies a significant amount of associated costs.

Going forward, the clinical research industry will experience an explosion of diagnostics and device studies.  Quibim is well equipped to play a big role in the infrastructure of the safety and analysis of several critical endpoints when it comes to biomarkers and image analysis.

Katherine Wilisch Ramírez

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