Capture layer · Module 04Evidence Capture & Exchange
Structured evidence, captured once, exchanged everywhere.
The Capture layer of ECS®, eCRF, ePRO/eCOA, eConsent, eSource, wearables ingestion and interoperability (CDISC · FHIR · HL7 · OMOP). Configurable schemas, edit checks, controlled vocabularies and export pipelines turn every interaction into regulator-ready, exchangeable data.
From an interaction to a regulator-ready dataset.
A single pipeline, no one-off ETL, no transcription layer.
Protocol-driven forms, BYOD, device streams.
Real-time validation, hard/soft stops, reviewer workflow.
MedDRA, WHODrug, LOINC, SNOMED, with human oversight.
SDTM-ready, HL7 FHIR endpoints, eTMF packaging.
Purpose-built, module by module.
Protocol-driven forms with versioning and conditional logic, real-time validation, auto-queries and reviewer workflows, with the audit trail intact throughout.
Validated instruments (licensed where needed), captured on any device the protocol allows, including BYOD with session integrity and audit-trail parity.
Three-level, revocable consent flows on the same identity spine, signatures, versions and re-consent captured in the audit trail.
Data captured once at source, participant, site or device, and reused across CRF, monitoring and export, with remote source verification built in.
Continuous device streams ingested with provenance, timestamps and quality flags, ready for analysis on arrival.
MedDRA, WHODrug, LOINC, SNOMED, coded at source or centrally, with human oversight and full traceability.
Native mapping to industry standards, SDTM-ready extracts, FHIR R4 endpoints, HL7 messaging and OMOP CDM for federated analytics.
CDISC ODM, SDTM extracts, REST hooks, continuously assembled eTMF, and, where privacy demands it, analysis that runs where the data lives.
Regulatory & standards frame.
The regulatory and standards backdrop this module is designed against.
Native mapping, SDTM-ready extracts and study data tabulation.
R4 resources and Device profiles for interoperability with EHRs.
Quality-by-design and critical-to-quality factors baked into schemas.
Selective safety-data collection supported at the form level.
Licensed dictionaries, coded at source or centrally, with oversight.
Electronic records and signatures, GxP-grade audit trail.
Built to be handed to a regulator, with regional data residency in the sponsor's jurisdiction.
The rest of ECS®.
Send the case report form you already have.
We map it into ECS® and show the edit checks, the health record ingestion and the export your statistician will actually receive.