MEDICAL DEVICES


ivain  am i tals throgh the firms devices, the trials they are being sed in and how they collect data otside the black box. Image credit: VivaLink


sensor itself. When the device is back in range with a mobile device or gateway that can then transmit data to the cloud, it automatically synchronises it. That’s so important for collecting continuous real-world data in your typical remote environment.


KP: How do you support your clients with data analysis?


SL: In addition to providing data – both the raw and the processed or smoothed-out data – we also provide advanced algorithms. We have algorithms that can detect over 15 different arrhythmia types, for example. Not every clinical research provider will have their own software to process the data, so we provide that as part of our service. We’re looking at other types of more advanced algorithms and software to process data, so that it presents not just data, but more of a clinical insight into a certain disease state.


KP: What are some of the trials in which your devices are being used? SL: We have a trial ongoing at the University


50 | Outsourcing In Clinical Trials


of California, San Francisco, which is very interesting as it’s one of the largest of its type using a continuous ECG monitor like ours in a population of 3,000 participants. The purpose of the trial is to basically identify biomarkers that give you early warning signs of atrial fibrillation Aib, which is the most common arrhythmia problem and causes a lot of issues, including increased levels of strokes. The way it’s treated today is more symptom-based. This study is to see if we can get an earlier indication of the onset of Aib to try to condct some kind of preventive medicine. To conduct such a large study like this, we need a lot of ECG data – something that can continuously capture the patient’s data in real- world situations over a long period of time. It’s an up to 10-year study that is now in its third year. The protocol calls for patients to wear our patch for about a week at a time, every month, on an ongoing basis. The unique design of our technology is very


well suited for that and so are the qualitative features. Our sensors are very small, non- intrusive and comfortable. You can wear one and you won’t even notice it under your


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