Icon Clinical may have just leapt in front of its competitors in cardiology trials. The imaging arm of the Dublin, Ireland-based contract research organization (CRO) just developed software for uploading and analyzing coronary angiography images, then exporting the measurements directly into a case report form that is 21 CFR Part 11-compliant.

Electronic Calipers

Thus far, no such capability has existed in the market. Jonathan Goldman, chief medical officer of Icon Medical Imaging, explains that those doing research on heart disease have traditionally focused closely on obstructive coronary artery disease, which accounts for the majority of heart disease diagnoses. Handy software for precisely quantifying any narrowing in the arteries in coronary artery disease has been around for decades. It uses electronic calipers, and it’s far better than measuring things subjectively, as in “this looks narrow here, I see a lump, or a bump. I ought to put a stent in there,” he says.

Icon’s Goldman

“Narrowing and length in each artery has to be noted. In a clinical trial, that has to be measured quantitatively—not visually. It has to be precise, with a lot of attention to detail,” Goldman, a cardiologist, says.

Report Flow

The process was a problem, though. Once the image of the arteries had been measured, and many detailed measurements were rendered, people had to write them into a case report form. This was expensive and time-consuming. Depending on the size of the study, it could take months.

Icon’s new innovation—quantitative coronary angiographic (QCA) analysis with an integrated electronic case report form (eCRF)—has elminated the need for people to do the input, and thus has increased accuracy and sped things up exponentially, Goldman says. The first trial that used the new product analyzed 200 images in three weeks, as opposed to taking several months.

To develop it, Icon integratrated QCAPlus, a popular QCA application from Sanders Data Systems, with an electronic case report form within Icon Medical Imaging’s proprietary Medical Image Review and Analysis (MIRA) system.

Icon Medical Imaging has conducted 42 trials in the area of cardiac imaging. The division has managed more than 220 imaging trials in oncology, central nervous system, medical devices and imaging agents.

—by Suz Redfearn