Use Case · EDC ↔ EHR

Trial data and chart data, finally in sync.

Stop double-keying labs, vitals and visit data between Clinera and Epic, Cerner or Athena. We build bidirectional FHIR/HL7 connectors that protect both research integrity and patient care.

The problem

What broken EDC ↔ EHR flow actually costs

Duplicate data entry

Coordinators retype labs, vitals and meds into EDC — burning hours and creating discrepancies.

Query backlogs

Source data verification queries pile up because EDC values drift from the chart of record.

Protocol deviations

Missed visits and out-of-window assessments slip through when sites can't see study context in the EHR.

Our solution

A two-way clinical data bridge

Step 01

Identify cohort

1 week

Match enrolled subjects between EDC and EHR with a deterministic + probabilistic MPI layer that handles real-world identifier drift.

Prerequisites
  • Subject identifier rules
  • EHR MRN access policy
  • Consent and re-consent flags
Deliverables
  • Match rules & MPI configuration
  • Initial match report & exception list
  • Steward review workflow
Tip: click any step above to inspect its plan.
Outcomes

What sites actually report

60%
Less duplicate data entry
Faster query resolution
40%
Fewer protocol deviations
100%
SDV evidence trail
What's included

Everything to make the bridge production-grade

  • Subject matching / MPI integration
  • FHIR R4 client with US Core profiles
  • HL7 v2 ingest for ADT, ORU, ORM messages
  • Consent and PHI boundary enforcement
  • Clinera eCRF write-back with provenance
  • Site-facing dashboards for sync health
  • Audit trail aligned to 21 CFR Part 11
  • Managed run support with SLAs
Compatible systems

EHRs and EDCs we connect

EHRs

Epic, Cerner / Oracle Health, Athenahealth, Meditech, NextGen, eClinicalWorks.

EDCs

Clinera, Medidata Rave, Veeva CDMS, REDCap, OpenClinica.

Lab vendors

LabCorp, Quest, plus central and local lab feeds via HL7 v2 ORU.

FAQ

EDC ↔ EHR integration questions

How long does a first integration take?+

A first production bridge for one study and one EHR typically takes 6–10 weeks, including validation and site rollout.

Do you need EHR admin access?+

We work through your IT and integration teams using sanctioned APIs (FHIR R4, HL7 v2) — no shadow connections, no scraping.

Is this allowed under HIPAA?+

Yes, with the right consent framework, BAAs and minimum-necessary controls — all of which we help you put in place.

Can this scale to many studies?+

Yes. We build the bridge as a platform, so adding a new study or site is configuration, not a new project.

Free discovery call

Ready to retire the EDC ↔ EHR double-entry tax?

Show us one study and one EHR — we'll come back with a bridge architecture and timeline.

  • ✓ Senior engineer reviews your inquiry
  • ✓ Reply within 1 business day
  • ✓ US-based, HIPAA-aware
  • ✓ Scoped plan in 48 hours

No spam. We reply within 1 business day. HIPAA-aware, US-based team.