Vitalograph - Model eCOA - Electronic Clinical Outcome Assessment
From Clinical Trials - Respiratory
Details
The eCOA are run through Spirotrac software and collected on Vitalograph In2itive e-Diaries or COMPACT.
Vitalograph views eCOA as a natural extension of the respiratory devices already being provided to trials and so only pass through associated licensing and copyright fees and require no additional device or service fees.
We provide a cost-effective and simple alternative to dedicated eCOA vendors.
Benefits
Vitalograph offers a single, integrated spirometer and e-Diary validated as a medical device. eCOA data collection is enabled by Spirotrac® software to centralize the Patient Reported and Clinician Reported Outcomes (PRO and ClinRO) data with other respiratory endpoints
- Innovative validated solutions for clinic and home use.
- Large touch screen devices with intuitive workflows for ease of use.
- eCOA only or combined endpoint options.
- Contemporaneous access to study data via Vitalograph Web Portal.
- Device solutions are configurable to meet protocol requirements such as:
- Symptom scores
- Medication use
- ePRO questionnaires
- Adaptable workflows
- Custom alerts, alarms and reminders
- Integrated wireless cellular/mobile communications option.
- Live spirometry blow quality feedback – promoting high-quality, reliable data.
- Integrated animated help file options supporting training and compliance.
- Date/time stamps ensure data integrity.
- Automatic end-to-end secure data transmission.
Capabilities
Vitalograph supports a full range of validated respiratory electronic PRO and ClinRO.
The eCOA are run through Spirotrac software and collected on Vitalograph In2itive e-Diaries or COMPACT Medical Workstation. This means we have complete control of the question sets and can be very flexible as regards content. For example, sponsor’s own questionnaires can be integrated and validated in Spirotrac software, providing efficiency and simplicity for your study. In addition to eCOA, Vitalograph solutions can measure lung function endpoints at home e.g. Peak flow, FEV1, and others.
Pre-integrated and validated ePRO questionnaires:
- Respiratory – asthma
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- ACQ MAPI
- AQLQ(S)12+ MAPI
- AQ20 Prof P Jones
- ACT Quality Metric
- Respiratory – COPD
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- EXACT Evidera
- EXACT E-RS Evidera
- CAT GSK
- Health status
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- EQ5D-3L Euroqol
- EQ5D-5L Euroqol
- SGRQ Jones PW
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