Since the turn of the century, the pharmaceutical industry has actively supported the steady increase in the use of digital health technologies, including the important transition from paper-based health records to electronic health record systems (EHRs). An increasing proportion of health data is now digital (known from a regulatory perspective as eSource), bringing benefits to patients and clinicians alike.
While these advances in healthcare data have been mirrored in clinical trial settings, healthcare and clinical research activities remain, overwhelmingly, in separate worlds. Estimates are that 70%1 of clinical trial data is duplicated between electronic data capture (EDC) systems used for clinical trials and EHRs. The current methods for transferring this data continue to be manual, open to transcription errors, hugely wasteful and, ultimately, severely restricting to our ability to trial and launch potentially life-saving treatments for patients.
