Next generation eCOA device with integrated respiratory assessment
Vitalograph are delighted to announce that their most powerful ever In2itive e-Diary is now available for global clinical trials, offering the ideal solution for respiratory endpoint studies.
The new In2itiveTM e-Diary is a robust handheld medical device with touchscreen for eCOA data gathering.
Using Vitalograph’s proven Fleisch Pneumotachograph flowhead, it provides accurate measurement of respiratory endpoints in clinic or for home monitoring.
Features
- Easy to use with large, high resolution, responsive touch screen.
- Live spirometry feedback promotes high quality, reliable data.
- Integrated training modules provide technique reminders supporting compliance and data quality.
- Alerts, reminders, and workflows are fully customizable to fit study protocols.
- Pre validated for a range of e-PROs to cover respiratory endpoints and health status.
- Date/time stamps ensuring data integrity.
- Secure end-to-end encrypted data transmission.
Fully integrated wireless communications (cellular/mobile) allow automatic secure transmission of data to the study web portal. Uploaded data is available for instant review, giving remote insight into site
and subject performance. The In2itive e-Diary is a fully validated class II (USA) / IIa (EU) medical device, meeting or exceeding all technical requirements for cyber-security and data protection.
The new device meets the performance requirements of ISO 23747 (peak flow), ISO 26782 (volumes) and adheres to guidance in the ATS/ERS joint 2019 technical statement on the standardization of spirometry.
About Vitalograph
Vitalograph is a global leader in respiratory diagnostic devices, clinical trial services and medical equipment servicing.
With a pioneering heritage of excellence spanning half a century, Vitalograph continues to make valuable contributions to effective medical care and enhanced quality of life.
Watch the In2itive e-Diary video here
Press contact | Helen Venn | helen.venn@vitalograph.co.uk
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