By Patrick Olsen
There’s no question that technology is continuously becoming more embedded throughout the clinical development process. The use of electronic data sources is no exception. More systems, processes, files, storage, and approvals are moving away from paper-based methods and toward applications that utilize electronic sources of data. Clinical trial data are no longer restricted to single-source applications; instead, data can come from multiple sources, including patient records (e.g., electronic health record (EHR)/electronic medical record (EMR)), mobile applications (e.g., electronic clinical outcome assessment (eCOA)/electronic patient reported outcomes (ePRO)), wearables and sensors, and electronic data capture (EDC) systems. As such, interoperability and usability of these electronic data sources are paramount. As technology in clinical development rapidly evolves, industry laggards may soon have no option but to embrace the use of electronic data sources. That said, how is the industry using electronic data sources? What improvements are needed? What challenges does the industry face?