Clinical research associates (CRAs) need immediate access to relevant and accurate site performance metrics, but information is often isolated within multiple databases and spread across different tracking systems. To deliver key site performance data to CRAs via mobile and web applications – quickly and conveniently – Covance has created a specialized clinical analytics suite of products, Covance Xcellerate® Informatics. This powerful solution integrates data from all sources and allows a CRA to gain a clear and concise view of all clinical trial data, in one place, for all the sites that a CRA is monitoring.
To enter the rapidly growing mobile health space, companies must overcome the crucial hurdle of validation. This process demonstrates that the app – in combination with the underlying technology platform / device – performs comparably to traditional products on the market, ensuring that patients and providers can rely on the output to make appropriate medical decisions.
Mobile health apps offer functions ranging from data collection to running algorithms, and underlying all of those features is the need for a quality system. To show that their product is reliable, developers need to take a variety of measurements, confirm that data transmission and analysis work correctly and test the app on multiple devices. Continue reading
For many technology companies entering the mobile health space, meeting US Food and Drug Administration (FDA) requirements may be unfamiliar territory. The guidelines can appear convoluted and contradictory at first glance, and some devices and/or applications (apps) fall into regulatory grey areas.
To make progress in this rapidly changing field, companies need to find a way to work within the regulations while encouraging creative development. Consulting with experts and the FDA, considering key design issues, taking precautionary quality measures and assessing global requirements will increase the chances that a company can bring a safe and successful mobile health device and/or app to market.