EHR-to-EDC Automation Benchmark Report 2025: Global Trends and Insights

Executive Summary‍

Clinical trials are rapidly shifting from manual transcription to automated, validated data flows between hospital EHRs and research EDC systems.

This 2025 benchmark summarizes adoption patterns, ROI signals, and operational impacts observed across sponsors, CROs, and research sites globally.

Organizations implementing EHR-to-EDC automation report faster database locks, reduced SDV effort, and higher data integrity under HIPAA, GDPR, and 21 CFR Part 11.

Key highlights:

• Adoption: 3× growth in EHR-to-EDC automation since 2022 (directional).
• Efficiency: Median SDV effort reduced by ~55% on auto-streamed fields (directional).
• Speed: Typical studies report database lock 7–14 days faster (directional).
• Quality: Fewer transcription errors and protocol deviations.
• Compliance: Aligns with HIPAA/GDPR and 21 CFR Part 11 with full audit trails.

1. Market Overview – The Road to Automation‍

Rising protocol complexity, hybrid and decentralized designs, and staffing constraints at sites are pushing sponsors and CROs to automate EHR-to-EDC data movement.

Standards like HL7® FHIR® and robust API ecosystems have matured, enabling platforms to orchestrate validated, near real-time data flows.

Regulators increasingly recognize eSource-aligned practices, giving stakeholders confidence to scale.

2. Methodology‍

Findings are derived from secondary research, aggregated implementation insights, and anonymized case patterns.

Qualitative signals are labeled as directional where applicable.

Metrics focus on operational deltas rather than absolute values; results vary by EHR/EDC mix, mapping scope, and site readiness.

3. Key Findings & Metrics

Adoption‍

EHR-to-EDC automation has more than tripled since 2022 in new study starts.

Phase II/III programs lead adoption; oncology and CNS show outsized uptake.

ROI‍

Sponsors report ~55% fewer SDV hours on auto-streamed fields and reduced manual data entry time.

CROs cite lower query volume and faster resolution cycles.

Data Quality‍

Automated validation and mapping minimize transcription errors, improving interim analyses and lock readiness.

Speed‍

Validated streaming supports earlier data availability; typical programs see 7–14 days faster database locks.

Compliance‍

Workflows align with HIPAA/GDPR privacy safeguards and 21 CFR Part 11 controls, with complete audit trails.

4. Case Highlights

Multisite Oncology (US/EU)‍

Challenge: Dual data entry strained coordinators.

Solution: FHIR-based EHR-to-EDC automation with rules-driven validation.

Result: ~60% reduction in SDV effort on targeted fields; cleaner interim analyses.

Academic Network (North America)‍

Challenge: Heterogeneous EHRs across sites.

Solution: Mapping templates, standardized value sets, and automated transformations.

Result: Faster query closure; improved cross-site consistency.

Early-Phase Biotech (Global)‍

Challenge: Limited DM resources and aggressive timelines.

Solution: Lightweight, API-driven automation to the EDC and analytics lake.

Result: Earlier signal detection; fewer data-entry errors.

5. ROI & Operational Impact‍

Automation’s returns concentrate in three buckets:

1. Reduced manual transcription and SDV.
2. Accelerated cycle times and database lock readiness.
3. Improved data quality that decreases rework.

Programs with clearly defined scope (targeted domains, standardized forms) realize gains fastest.

6. Future Outlook (2025–2027)‍

Expect broader mandates for EHR-to-EDC automation in RFPs, deeper interoperability with registries and data lakes, and AI-assisted mapping and anomaly detection.

Vendor ecosystems will consolidate around standards-driven, multi-destination data pipelines (“EHR-to-Anywhere”).

7. Recommendations

For Sponsors

• Define automation scope during protocol design; prioritize high-value forms/fields.
• Standardize on FHIR-ready connections and value sets across sites.
• Include automation requirements and validation plans in RFPs and vendor selection.

For CROs

• Build an automation playbook and designate study-level champions.
• Align DM, PM, and site enablement on mapping, QC, and change control.
• Track SDV hours, query rate, and lock time to quantify ROI.

For Sites

• Assess EHR readiness and engage IT early for access and security reviews.
• Pilot targeted domains first; expand as mapping templates mature.
• Train staff on validation workflows and capture internal ROI metrics.

About Yonalink‍

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Call to Action‍

Request a personalized benchmark analysis or schedule a demo to explore how EHR-to-EDC automation can accelerate your next study.

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