HomeVitalograph In2itive e-diary
Revolutionising ePRO
The pioneering In2itive™ e-Diary combines an integrated spirometer, featuring a removable flow head, with an easy to use touch screen. This versatile ePRO system is the first of its kind and can be customised for use in any protocol-driven clinical trial in a wide range of therapeutic areas.
Designed to improve on the success of the already well-proven PEF/FEV1 Diary, (3,4,5,6) with its documented 92% subject compliance,(5,6) the In2itive e-diary excels in the following key areas:
for Communications
Secure data transfer from the study centre or transmitted directly from the subject‘s home for immediate population of centralised study database
Ability to transmit data over phone networks allowing real time data capture
Real time data access via the VIEWER™ web portal allowing site, CRO and sponsor to review the data and monitor compliance
Secure mirrored backups, local on device and remote at data management centre for absolute protection of source data
for Spirometry
Diagnostic spirometry accuracy
Ability to capture full flow-volume data and a range of parameters in respiratory studies
Test QA feedback to the subject on PEF and FEV1 to maximise data quality in respiratory studies
Validated against the ATS/ERS 2005 standards and ISO standards for spirometry and peak expiratory flow (7,8,9)
for Electronic Diary
Records symptoms, medication use, patient reported outcomes & quality of life questions for any therapeutic area
Removable spirometry flowhead so that the e-Diary can be used in non-respiratory studies
Simple to use large touch screen interface
Meets international data protection requirements
Compliant with the FDA‘s guidance(1) on patient reported outcomes
FDA 21CFR Part 11 compliant(2)
Automated date/time stamped records
for Patient Compliance
On-screen quality feedback for diagnostic spirometry
Available in all languages with a clear and bold font
Fully customisable subject alerts
Time windows for record entry so that the subject can only record results within a specified period
Responses to diary questions are mandatory before proceeding
Optional remote QA review of subject tests and compliance feedback
Audit trail of all user activity
Unique user passcode login - restricts access to authorised users and correct subjects
Training mode via investigator login removes the need for a dedicated demo diary at site
for Additional Features
Completely tailored to meet the targets and endpoints of your study protocol
Stores more than 1 year‘s data for a single subject
The ability to ship identical devices to all sites irrespective of language
The user can continue where they left off if a diary session is interrupted
Automatic adjustment for daylight savings changes
Integrated within a single centralised database including site spirometry, FeNO and other study data
for References
