Abrahama Gutman: You have to check the sub-assemblies where they are being assembled and put together into a data submission, which occurs typically every six weeks for a period of three to four years. You should also check that the submission meets the requirements of the charter of the clinical trial. It’s important and is typically done after the data has been sent. What we have been doing is developing more and more functionality that checks the quality of that data before the data leaves the clinical site. Think of it as a hospital somewhere in Southern China, Northern India, or Russia. It checks that quality.
Sramana Mitra: When you say it checks the quality, can you illustrate what that involves. Are we talking about metadata?
Abrahama Gutman: It’s in number of dimensions. Let me take it top-down. Metadata is one of them. One is typically when you are taking a CT scan. It contains metadata and has the patient name, the patient age, and a bunch of other parameters that were set in the scanner. The person who is sending the data, by the way, is not the same person who scanned the patient. This person, who’s called the trial coordinator, gets a CD from somebody. They are told that this contains the data for this patient. They have to de-identify the data and modify it to ensure that you get the proper patient number. If that doesn’t happen correctly, the data cannot be analyzed. In fact, it would be violating all sorts of national regulations all over the world. We ensure, for example, that the data is properly de-identified before it moves from the hospital.
Second, there are these transmittal forms that have to accompany this data. These are typically filled by hand. We ensure that not only are those properly filled, but that they are calso onsistent with the metadata. We ensure that there are no discrepancies.
When there are discrepancies, there’s a query process. They arrive at the lab. The lab realizes that there are problems with the data. The data has to be quarantined. It cannot be analyzed. They have to talk to some nurse in a hospital in rural Ukraine and say, “How come you said that this patient weighs 230 lbs? The images say that the patient weighs 180 lbs.” That process of querying back and forth can delay a trial significantly. It can delay the analysis of that data by seven weeks. That’s very significant. That’s one level of quality.