OpenClinica’s eSource solution, Unite, automates source data acquisition from patient medical record systems (EHRs and EMRs) to clinical trial research databases (EDCs) and case report forms (eCRFs) at scale. This secure bridge between healthcare and research eliminates manual data transcription and is especially suited for rigorous GCP and Part 11-compliant clinical trials. Unite is backed by a rapidly growing network of over 450 physical clinical trial sites across major health systems serving tens of millions of patients.
Sponsors gain early and consistent access to reliable data enabling quicker decision-making and reduced time-to-market.
From the outset, incorporating source data instills confidence among stakeholders in the information they receive. Furthermore, Unite surpasses both national and global compliance benchmarks, ensuring the utmost data quality.
Accessing high-quality study data in real-time facilitates an earlier understanding of potential safety signals.
Clinical research sites can readily engage in studies, assisting sponsors in adhering to FDA draft guidance on trial diversity.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.
eSource frees up site staff to focus on patients, fostering greater engagement and sustained participation throughout the duration of the study.
EHR integration alleviates the load on research sites, potentially boosting their eagerness to partake in studies and effectively recruit patients.
Clinical trials incur significant costs due to the collection and abstraction of clinical data, exacerbated by human errors. Sponsors who utilize Unite experience a remarkable 61% reduction in time compared to sites employing manual data abstraction. This is merely the initial advantage.
The advanced development of technical standards, such as SMART on FHIR, results in sites becoming operational within hours, rather than days or weeks.
Unite eSource enables genuine data interoperability, enhancing study 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.
Stop wasting time and resources. Focus on what you do best — improving lives through innovative, transformative research. EHR data integration will help you:
Offer sponsors and sites a market-leading, proven EHR eSource integration solution that is EDC/EMC/EDC agnostic. EHR EDC integration enables our CRO customers to:
Our open source roots mean we understand the challenges facing AROs. EHR data integration will help you:
CRCs and CRAs are the unsung heroes of clinical trials. Integrating EMR data into your clinical trials will help:
Update your browser to view this website correctly. Update my browser now