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CLEHR

Real-world data extraction from health system EHRs for clinical trials, eliminating manual data entry and source verification.

Solution by Graticule
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Overview

CLEHR (Clinical from EHR) is Graticule's global eSourcing network designed to connect clinical trial sponsors directly to health system electronic health records (EHRs). Built for life sciences sponsors, contract research organizations (CROs), and healthcare providers, CLEHR unlocks real-world data at scale for clinical studies through secure, standards-based interoperability — eliminating the inefficiencies of legacy manual data collection workflows.

Traditional clinical data collection relies on outdated "cut-and-paste" processes where Clinical Research Coordinators manually transfer EHR data into Case Report Forms (CRFs) within Electronic Data Capture (EDC) systems. This approach places a significant burden on site staff, contributes to site burnout, is time-consuming, and limits a health system's capacity to support research. Furthermore, reliance on EDC forms constrains study design, reduces analytical opportunities, and makes protocol changes costly and inflexible. CLEHR was built to solve these longstanding industry challenges at scale.

How CLEHR Works

  • CLEHR operates as a secure honest broker cloud service that seamlessly links site health system EHRs with sponsor IT systems, creating a powerful global digital network for eSourcing.
  • It leverages USCDI (United States Core Data for Interoperability) open standards — a "toll free highway" for data transfer — providing access to EHRs without recurring EMR API costs.
  • Data is transferred securely and in de-identified form from EHR records to sponsor systems, enhancing research data collection while ensuring data quality and accuracy.
  • CLEHR integrates leading Integrated Delivery Networks (IDNs) and healthcare providers, connecting sponsors and sites through standardized eSourcing infrastructure.

Key Benefits of CLEHR eSourcing

  • Efficient data transfer: Reduces manual data entry to accelerate evidence generation. In recent use cases, 70% of the data transfer process is automated, with only 30% requiring manual effort for legitimate reasons.
  • Eliminates Source Data Verification (SDV): Because data is acquired directly from the source, there is no need for SDV requests back to sites, effectively reducing SDV time to zero.
  • Superior data quality: Granular and relevant data provides a clear, accurate clinical picture of each patient and greater insight into trends — far exceeding what manual transcription captures.
  • Comprehensive data capture: In a single-patient example, CLEHR sourced 291 blood pressure measures compared to only 2 captured via manual EDC entry, and tracked 360 patient encounters versus only re-admission tracked manually.

CLEHR Network Milestones and Capabilities

  • Rapid Site Activation: CLEHR has integrated an adapter into the Epic Showcase, enabling sites to go live quickly — often in less than 4 weeks.
  • 80+ Million Strong Global Patient Network: Data is actively flowing into live studies from sites, with volumes surpassing expectations, ensuring timely and reliable data collection.
  • Efficient Reuse: Sites can reuse their initial CLEHR connections across multiple studies, eliminating the need for new startup integrations for each individual study.
  • Strong Vendor Partnerships: CROs and EDC tool vendors are actively partnering with CLEHR to accelerate platform access for their clients, driving broader adoption and operational efficiency.

CLEHR is deployed as a secure cloud-based honest broker service and integrates with major EHR platforms including Epic. By leveraging USCDI open standards, it provides a scalable, cost-effective interoperability framework that supports sponsors, sites, CROs, and EDC vendors across global clinical research programs.

Meta

Domain
Clinical Trial Management
Subdomain
Electronic Data Capture (EDC)
Software type(s)
Integration / Middleware
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
BiotechCROMedical DevicesPharma
Development stage(s)
ClinicalPost-Market & RWE
Target user(s)
Research ScientistClinical / Diagnostic ProfessionalIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11HIPAAGDPR