Unite

Unite is OpenClinica's EHR-to-EDC eSource solution, designed to automate the flow of patient medical record data directly into clinical trial study databases. By eliminating manual transcription and copy-paste workflows, Unite reduces site burden, accelerates source data verification, and improves overall data quality. It is purpose-built for small to midsize sponsors, CROs, academic researchers, and health system-based research teams who need a proven, scalable, and standards-based integration without the complexity of managing separate vendor contracts.

Backed by a network of over 450 clinical trial sites across major health systems and trusted by more than 1,500 sponsors, CROs, and research sites worldwide, Unite delivers rigorous GCP and 21 CFR Part 11-compliant data capture with transparent pricing and dedicated support included.

Who Unite Is For

• Academic Researchers: Bridge the gap between healthcare and research by pulling clinical data directly into studies while maintaining GCP and Part 11 compliance.
• Sponsors & CROs: Scale EHR-to-EDC integration across multiple sites without vendor sprawl, as Unite is part of the OpenClinica platform rather than a separate contract.
• Sites & Coordinators: Stop retyping vitals, labs, medications, and medical history — coordinators review and confirm data instead of transcribing from scratch.
• Small to midsize sponsors and CROs seeking modular, cost-effective eClinical solutions.
• Multi-site studies across health systems requiring consistent, automated data acquisition.
• Real-world evidence (RWE) studies and trials requiring extensive medical history or lab data.

Key Benefits

• Less site burden, higher satisfaction: Eliminating hours of manual transcription allows site staff to focus on patients rather than paperwork, boosting engagement and willingness to participate in future studies.
• Superior data quality from day one: EHR source data meets national and global compliance benchmarks and enables faster identification of safety signals and adverse events.
• Faster decisions, reduced time-to-market: Reliable data flowing directly from EHRs to study forms enables quicker, more confident decision-making throughout the trial lifecycle.
• Cost-effective operations: Sites using EHR-to-EDC reduce data collection costs by 61% compared to manual data abstraction methods.
• Rapid site activation: FHIR and HL7 standards enable sites to become operational in hours rather than days or weeks, making it easier for diverse sites to participate.
• Future-ready integration: True data interoperability opens doors to novel data sources including medical devices, wearables, and smartphones, expanding therapy development opportunities.

How Unite Works

1. Map your data elements: Identify which clinical data elements — including vitals, labs, medications, and medical history — need to flow from the EHR into study CRFs.
2. Connect securely: Establish a secure, standards-based connection between any EHR and OpenClinica EDC using FHIR or HL7 protocols.
3. Automate data flow: Clinical data flows automatically from the EHR to study forms, with coordinators reviewing and confirming entries rather than performing manual transcription.
4. Monitor with confidence: Source data verification occurs in real time, with monitors verifying data against the actual EHR source supported by complete audit trails.

Features and Capabilities

• Standards-based interoperability using FHIR and HL7 — no custom integrations required
• Secure bridge between EHR systems and EDC platforms
• Support for major EHR systems including Epic, Cerner, and more
• Network of 450+ clinical trial sites across major health systems
• Automated source data acquisition at scale
• Real-time data validation and coordinator review workflows
• GCP and 21 CFR Part 11 compliant data capture
• Complete audit trails linking EDC entries back to the EHR source
• Modular design — functions as a standalone solution or integrated with OpenClinica EDC
• Transparent, predictable pricing model
• 24/5 support included

Unite is deployable as a modular component within the broader OpenClinica eClinical platform, allowing teams to adopt EHR-to-EDC integration alongside EDC, eConsent, eCOA, randomization, and reporting capabilities. Its system-agnostic architecture ensures compatibility across diverse health system environments, making it a flexible and future-ready choice for organizations seeking to modernize clinical data collection.