ICYMI, OpenClinica published a playbook, Fast-tracking clinical trials with eSource: Get to market faster and enhance site relationships.
In the playbook, we detailed nine key advantages that accrue to clinical trials using eSource EHR integration:
One: Speed
EHR to EDC integration accelerates clinical trial study timelines and decision-making. Sponsors gain early and consistent access to reliable data and faster finalized data, which reduces time-to-market.
Two: Quality
From the outset, incorporating source data instills confidence among stakeholders in the information they receive. Sponsors also can minimize – or even eliminate – the costly and time-intensive errors associated with manual data entry as well as reduce SDV.
Three: Safety
Accessing high-quality study data in real-time facilitates an earlier understanding of potential safety signals.
Four: Diversity
Resource-strapped sites can more easily participate in clinical research. Clinical research sites can readily engage in studies, assisting sponsors in adhering to FDA draft guidance on trial diversity. This approach ensures the consistent efficacy of therapies across a wider range of populations.
Five: Retention
eSource frees up site staff to focus on patients, fostering greater engagement and sustained participation throughout the duration of the study.
Six: Site Satisfaction
EHR integration eliminates manual clinical trial data transcription and alleviates the load on research sites, potentially boosting their eagerness to partake in studies and effectively recruit patients. As the data entry burden lessons, site relationships improve. Sites may even be more inclined to take on protocols if they offer technology that clinical research coordinators (CRCs) and investigators know and appreciate.
Seven: Cost Containment
Clinical trials incur significant costs due to the collection and abstraction of clinical data, exacerbated by human errors. With higher quality source data, sponsors can mitigate the costs of SDV and wasted personnel hours, refocusing on them on higher-value activities such as patient encounters.
Sponsors who utilize OpenClinica’s eSource EHR integration solution, Unite™, experience a remarkable 16-minute per form savings for elapsed data entry time on the primary daily electronic case report form (eCFR), a 61 percent reduction compared to sites employing manual data abstraction.
Eight: Scalability
The advanced development of technical standards, such as SMART on FHIR, results in sites becoming operational within hours, rather than days or weeks. Sponsors can expand data capture beyond limited protocols, using more data for more outputs in a single click.
Nine: Strategic Growth
Unite eSource enables genuine data interoperability, enhancing study insights and outcomes through the incorporation of novel data sources like medical devices, wearables, and smartphones. This broadens opportunities for therapy development, allowing data to be shared with a wider array of research destinations.
To learn more about how automated data capture through eSource EHR integration benefits sites, sponsors, clinical trial researchers and patients, download our playbook: Fast-tracking clinical trials with eSource: Get to market faster and enhance site relationships.