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Clinical Trials

Centralised Spirometry

Fast review of spirometry data for acceptability and repeatability is becoming increasingly important, and the Vitalograph Spirotrac Centralised Spirometry System provides a unique and revolutionary solution.

The investigator simply clicks on the transmit button and encrypted data is automatically sent to the Vitalograph Data Management Centre for the ATS/ERS experts to review the quality of the data and provide feedback to the sites and the sponsor. The data can also be transmitted directly to the sponsor's own DM centre.

Web based data can be accessed for easy monitoring of the progress of a complete study, by country, by site, by patient via the VIEWER reporting portal.

An audit trail is created of who, what, when and why of anything that is created or modified. Nothing can be deleted.

Customised software and manuals are available with installation and training at the sites and at Investigator and Monitor meetings. We will also work with EDC companies to integrate our data with an e-CRF system.

Vitalograph Centralised Spirometry
  • Standardised systems
  • Customised to study protocol
  • Expert QA review
  • Centralised data management
  • Calibration check forced daily
  • FDA 21CFR part 11, 95/46/EC and HIPAA compliant
  • Integrated methacholine challenge testing
  • Integrated, centralised, PEF/FEV1 e-Diary