HomeSpirotrac® Centralized Pulmonary
Function and Diary System
Standardized systems
Customized to Study Protocol
Expert QA review
Centralized Data Management
Calibration check
forced daily
FDA 21CFR Part 11 and
HIPAA compliant
Integrated Methacholine Challenge Testing
Integrated, Centralized, PEF/FEV1 Diary
Overview
Fast review of spirometry data for acceptability and repeatability is becoming increasingly important, and the Vitalograph Spirotrac® Centralized Spirometry System provides a unique and revolutionary solution.
The investigator simply clicks on the e-mail button and encrypted data is automatically transmitted to the Vitalograph Data Management Center 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 Center.
Web based data can also be accessed for easy monitoring of the progress of a complete study, by country, by site, by patient.
An audit trail is created of who, what, when and why of anything that is created or modified. Nothing can be deleted.
Customized 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.
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