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eCOA

Electronic Clinical Outcome Assessments

Patient diaries, questionnaires, and clinical assessments

Capture validated patient-reported outcomes, symptom diaries, and quality-of-life instruments digitally — integrated with objective respiratory device data in a single platform.

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Capabilities

Key Features

Multi-Device Access

Patients complete assessments on smartphone, tablet, or web. Flexible deployment based on study needs.

Validated Instruments

Support for standard respiratory PRO instruments including SGRQ, ACQ, AQLQ, CAT, E-RS, and custom questionnaires.

Real-Time Collection

Automated reminders and real-time submission tracking minimize missing data and improve compliance rates.

Integrated Data

PRO data flows into the same platform as objective device data, enabling correlated analysis across endpoints.

21 CFR Part 11 Compliant

Audit trails, electronic signatures, and data integrity controls for regulatory compliance.

Symptom Diaries

Daily symptom diaries capture patient experience alongside objective cough, lung sound, and spirometry data.

Clinical Value

Subjective + objective: the complete picture

Patient-reported outcomes are essential but limited by recall bias and subjectivity. Integrating PROs with objective device data provides a more complete and credible endpoint strategy.

1

Reduce recall bias

Digital diaries with real-time collection minimize the gap between symptom experience and data capture.

2

Validate subjective with objective

Correlate patient-reported symptoms with objective cough counts, lung sounds, and spirometry for stronger evidence.

3

Improve compliance

Automated reminders, intuitive interfaces, and minimal burden design drive completion rates above 90%.

4

Unified reporting

A single data platform for all endpoints means faster analysis, cleaner databases, and more efficient submissions.

Assessment Types

Three Types of eCOA

Different perspectives on patient outcomes, all captured digitally and integrated into a single platform.

ePRO

ePRO

Electronic Patient-Reported Outcomes

Validated symptom assessments and quality-of-life instruments completed directly by patients, capturing their subjective experience of disease and treatment.

eClinRO

eClinRO

Electronic Clinician-Reported Outcomes

Clinical assessments and observations recorded by healthcare providers using digital forms, standardized scales, and structured data collection.

eObsRO

eObsRO

Electronic Observer-Reported Outcomes

Structured observations recorded by caregivers or other third parties, capturing their assessment of patient status and treatment response.

The bridge between objective and subjective

eCOA is the layer that connects patient experience with device-measured reality. Together they tell the complete story of treatment effect.

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