Innovative Solutions to Overcome eSource Challenges
eSource (defined as data initially recorded in an electronic format) formats have provided excellent opportunities to not only streamline clinical research securely, but to increase data quality and trustworthiness. As these methods are continually reviewed for newer and better processes to be leveraged, challenges arise. In effect, many cutting-edge technologies have been developed as the need for more robust data capture practices and technologies have increased. Over time, eSource formats have evolved to meet these challenges, but some still remain, including data validation and accuracy, integration with other clinical trial data, data control, and the differing nature of data formats and data models employed by vendors across electronic health records (EHRs).
Elligo Health Research, a healthcare-enabling research organization, sought to change the way clinical research was carried out by creating a model that focused on providing physicians with direct access to research as care option for their patients without disrupting their existing workflow. Elligo began utilizing EHR data as an eSource tool to enable these practices to identify a more diverse patient population in clinical research. The approach quickly provides physicians, sponsors, and ultimately, patients, with better outcomes remotely. This presented a new set of challenges to overcome as the use of EHRs led to inconsistencies with varied data models and the data needed to continue research was often not represented.
To combat these challenges, Elligo developed an eSource study documentation tool within our proprietary state-of-the-art research platform, IntElligo Research Stack™. IntElligo was designed to work in real-world healthcare by collecting data at the point of care using CDISC global research data standards. In addition to utilizing EHR data, IntElligo automates administrative tasks and alerts for quality issues to streamline data output. This allows the focus to remain on the patient by making previously cumbersome tasks part of an automated workflow that ensures optimized clinical trials from start to finish. When implemented as designed, this eSource study documentation tool enables streamlined processes:
- Collecting quality source data in a standard format from the start, supporting regulatory submissions with minimal mapping
- Accelerating access to management information and remote monitoring
- Reducing resource requirements
By continually looking at the challenges of eSource through a new lens, Elligo provides solutions that allow direct oversight and management of trials remotely at a time when this is especially important. This approach ultimately saves valuable time and resources, but most importantly, it allows Elligo to provide physicians with direct access to clinical research as a healthcare option for their patients.