Clinera EDC, implemented right — from study build to go-live.
We help sponsors, CROs and sites stand up Clinera EDC fast: validated study builds, role-based workflows, and turnkey integrations to EHR, FHIR, labs and ePRO so your data is clean from first subject in.
An end-to-end Clinera EDC capability
Study & eCRF build
Protocol-aligned eCRF design, edit checks, derivations and visit schedules built and validated to Clinera best practice.
System configuration
Roles, sites, blinding, randomization, drug accountability, and query workflows tuned to your SOPs.
Integrations & APIs
Bidirectional pipelines to EHR, FHIR, central labs, ePRO/eCOA, IRT/RTSM and CTMS — no manual re-entry.
Validation & 21 CFR Part 11
IQ/OQ/PQ packages, traceability matrices, and audit trails ready for sponsor and inspector review.
Risk-based monitoring
Site performance signals, query aging, and protocol deviation triggers piped into your monitoring stack.
Reporting & exports
SDTM-aligned exports, CDISC mappings and live study dashboards for ops, biostats and medical monitors.
A proven Clinera EDC delivery workflow
Discovery
1–2 weeksProtocol review, stakeholder interviews, integration inventory and a fixed-scope plan with a named US-based delivery lead.
- Final or near-final protocol
- List of source systems (EHR, labs, ePRO, IRT)
- Stakeholder availability (DM, biostats, IT/Security)
- Integration inventory & data flow diagram
- Fixed-scope SoW with milestones
- Risk register and assumptions log
What teams see after a Clinera engagement
Everything your study needs from one team
- Protocol-to-eCRF design and edit-check authoring
- Site, role and randomization configuration
- Clinera ↔ Epic, Cerner, Athena and other EHR connectors
- FHIR R4 ingest and HL7 v2 lab feeds
- ePRO / eCOA, IRT and CTMS integrations
- SDTM/ADaM-friendly exports and CDISC mappings
- 21 CFR Part 11 validation pack and SOPs
- Site training, hypercare and managed run support
Common questions about Clinera EDC
Do you work with existing Clinera studies or only new builds?+
Both. We onboard mid-flight studies for optimization, integration work, or Part 11 remediation, and we also build new studies from protocol.
Can you integrate Clinera with our EHR?+
Yes. We build production-grade connectors to Epic, Cerner, Athena and other EHRs using FHIR R4 and HL7 v2 with full audit trails.
Are you HIPAA and 21 CFR Part 11 aligned?+
Yes. Every engagement ships with HIPAA-aligned controls and a Part 11 validation package — IQ/OQ/PQ, traceability matrix and electronic-signature workflows.
Where is your team based?+
We are US-based and serve sponsors, CROs and health systems across the United States.
Ready to stand up Clinera EDC the right way?
Book a 30-minute discovery call and walk out with a delivery plan and a fixed-scope estimate.
- ✓ Senior engineer reviews your inquiry
- ✓ Reply within 1 business day
- ✓ US-based, HIPAA-aware
- ✓ Scoped plan in 48 hours