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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