eSource
EHR EDC Integration
at its Best

Auto-populate eCRFs with source data on study day one with OpenClinica Unite™

OC-Unite-eSource EHR EDC Integration

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.

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.

9 Key Advantages of Unite eSource: EHR EDC Integration

  • Speed

    Sponsors gain early and consistent access to reliable data enabling quicker decision-making and reduced time-to-market.

  • Quality

    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.

  • Safety

    Accessing high-quality study data in real-time facilitates an earlier understanding of potential safety signals.

  • Diversity

    Clinical research sites can readily engage in studies, assisting sponsors in adhering to FDA draft guidance on trial diversity.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.

  • Retention

    eSource frees up site staff to focus on patients, fostering greater engagement and sustained participation throughout the duration of the study.

  • Site Satisfaction

    EHR integration alleviates the load on research sites, potentially boosting their eagerness to partake in studies and effectively recruit patients.

  • Cost Containment

    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.

  • Scalability

    The advanced development of technical standards, such as SMART on FHIR, results in sites becoming operational within hours, rather than days or weeks.

  • Strategic Growth

    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.

Ready to see if Unite eSource is right for your organization?

Ehr-edc-ecrf-integration-esource

From any EHR to any EDC, Unite eSource Delivers Seamless Workflows

  • Launch Unite within patient chart in EHR or EMR
  • Eliminate multiple logins & passwords
  • Reduce downstream impacts such as SDV
  • Enhance insights with summaries, trends and visualizations

Commitment to Innovation in Clinical Research

  • First to unlock benefits of open source
  • Pioneers of cloud adoption
  • Set standards for anytime, anywhere user experience
  • Participate in development of regulation and interoperability standards
  • Focus on uniting clinical research & medical care through EHR EDC integration
eSource: Another innovation for clinical trials from OpenClinica

eSource Benefits all Clinical Trial Stakeholders

EMR EDC Integration for sponsors of clinical trials
Sponsors

Stop wasting time and resources. Focus on what you do best — improving lives through innovative, transformative research. EHR data integration will help you:

  • Eliminate high-risk manual data entry
  • Reduce monitoring cost, delays and effort
  • Get faster access to steady stream of trusted data
  • Scale painlessly across site networks & studies
  • Rapid and easy reusability
EHR Integration for CROs
Contract Research Organizations

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:

  • Differentiate your CRO
  • Meet deadlines more consistently
  • Reduce overhead to price studies more profitably
e-source-for-clinical-trials
Academic Research Organizations

Our open source roots mean we understand the challenges facing AROs. EHR data integration will help you:

  • Easily share and standardize EHR source data capture in multicenter clinical trials
  • Lower operation costs, optimize research funding
  • Increase profitability
  • Streamline data collection among major patient registries
EMR integration for sites and site networks
Sites & Site Networks

CRCs and CRAs are the unsung heroes of clinical trials. Integrating EMR data into your clinical trials will help:

  • Retain quality staff by reducing burden of mundane data entry
  • Reduce manual data entry from hours to minutes
  • Enhance patient safety and care by tracking key metrics
  • Leverage eSource across multiple studies & sponsors
  • Participate in more studies, more profitably

Regulatory Compliance with EHR eSource Data Capture

  • Built on Part 11-Compliant EDC
  • Compliant with HIPAA and GDPR
  • Traceability to source (data originator, data element identifiers) per FDA 2018 EHR guidance
  • Comprehensive information security program
  • Compliance and security artifacts available for customer review

Site Implementation, Integration and Standardization

  • Secure, standards-based technology
  • Widely accepted by health system IT departments
  • Backed by major EHR vendors
  • Lightweight implementation because there’s no software to install
  • User-driven access to data makes it easily auditable
  • Usable across multiple trials and sponsors
  • Hybrid options available — not all sites need to adopt to realize positive ROI
  • Ready in 4-5 weeks

 

Every project begins with a conversation.

Client Testimonials

“We save an enormous amount of time and eliminate errors because we can pull laboratory and medication data from our EHR at the click of a button.”

– Principal Solutions Architect

“The implementation was quick and easy. We received excellent support from the OpenClinica team. They were available and ready to help our strong internal team and we were able to shave a full week off our initial projection.”

– Project Director, Research/Executive

“We can’t recommend the OpenClinica app and team enough, and we are thankful our collaboration continues with other high-visibility projects!”

– IT User

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