Remote Patient Monitoring service for clinical trials and real-world data studies.
Real world data is becoming increasingly important in the post-marketing stages of drug development. Additionally, complex and distributed trial designs often require tools to monitor study outcomes objectively and remotely.
The Byteflies platform, which is the engine behind our Care@Home applications, is a certified, audited, and validated system for collecting wearable-based endpoints in your clinical trial or as part of an real world data study.
The Byteflies Platform
Clinical trial and real world data study tools solutions are powered by the state-of-the-art Byteflies platform. Accurate, secure, safe, user-friendly, powerful, scalable, and agile are some of the principles our engineers uphold when meticulously designing each component. Our wearables and software are certified medical devices, and our cloud infrastructure, algorithms and apps are designed with patient confidentiality, interoperability and data governance in mind.
Accelerate clinical trials in Pharma. Bringing a new drug to market costs $1B-10B and takes 10-15 years so all innovations that attempt to improve the drug development process are important. Distributed clinical trials are one such innovation. They increase the number of subjects that can be enrolled at once, and the quality and quantity of real-world evidence that is generated. Wearable health devices are the crux of distributed trials as they enable 24/7 vital sign collection, escape the physical barriers of trial site, and provide a direct line of communication with the subject, no matter where they are. By being monitored from the comfort of their own homes, patient recruitment goes much more quickly, which also can help shorten the duration of clinical trials. All of this could speed up drug trials by up to one or two years.
A tool for value-based healthcare. Proving the efficacy of a drug, both in the short and long-term is becoming increasingly important for providers. A wearable health device can extend a care strategy into the home environment, provide the means for medical professionals to react more promptly to relapses, generate continuous and objective cohort data, and monitor treatment adherence.
Validate your new technology. New biosensors or signal processing algorithms should be benchmarked out of the lab to verify their performance. We can provide you with the tools to implement your new technology into a wearable device, and test it under real-world circumstances.
Digital biomarkers. The age of powerful and accessible traditional biomarkers has only just began, but the advent of a new category of digital biomarkers is already upon us. While the latter are usually less specific, they more than make up for this by their always-on nature. Our platform can generate the rich datasets needed to develop algorithms for advanced multimodal vital sign monitoring.
ISO 13485 & FDA 21 CFR Part 820 compliant
Audited by several pharma companies
CE marked MDR 2017/745 and/or FDA 510(k) cleared
GDPR 2016/679 and HIPAA compliant
Following ISO 27001 industry standards
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Interested to explore how our solutions and services can help you?