Case study · Academic health system · Multi-site

Live Clinera ↔ Epic integration with FHIR R4 + MPI

Site coordinators were double-entering visit data into Epic and Clinera. We built a bidirectional FHIR R4 integration with master-patient-index matching and query write-back — and shipped it without disrupting clinical workflow.

EDC EHR integration

The situation

Coordinators across 6 sites were re-keying labs, vitals, meds and demographics from Epic into Clinera. Lag was 24–72 hours, error rate was material, and the trial was missing key data-quality SLAs with the sponsor.

What we did

  • • Profiled the Epic FHIR R4 endpoint against required resources (Patient, Observation, Condition, MedicationRequest, Encounter).
  • • Built an MPI matcher so trial subjects are deterministically linked to their Epic record (MRN + DOB + name + study ID).
  • • Stood up event-driven ingestion: Epic → FHIR subscription → message queue → mapping → Clinera write.
  • • Implemented query write-back: Clinera queries flagged as needing source confirmation surface in the coordinator's Epic in-basket.
  • • Delivered a PHI boundary, audit trail and Part 11 evidence as part of the integration validation pack.

The result

80%
Less manual entry
<2 min
EHR-to-EDC latency
0
PHI incidents in 12 months
6 sites
On the live integration

Coordinators got their afternoons back. The DM lead now monitors quality instead of chasing entries. The sponsor extended the engagement to two additional studies.

What the client said

"Other vendors quoted us six months and a six-figure integration. Elintex shipped the first site in eight weeks, with the validation evidence in hand."
— Director of Research Informatics
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