IN2ITIVE e-DIARY RESPIRATORY eCOA / ePRO - Data you can rely on. People you can trust - Vitalograph
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IN2ITIVE e-DIARY
RESPIRATORY eCOA / ePRO
Data you can rely on. People you can trust.
IN2ITIVE e-DIARY
The key to any successful clinical trial is the quality of In addition, the device offers comprehensive training
the collected data. options, animated help files and in-depth user
The new In2itive™ e-Diary is a custom built Electronic feedback to ensure the right eCOA and spirometry
Clinical Outcome Assessment (eCOA) platform data is captured from the patient’s home.
integrated in a highly accurate and robust home The In2itive e-Diary is a fully validated class IIa
spirometer, designed to achieve consistently accurate medical device that meets or exceeds all technical
data and high levels of data security. requirements for cyber-security and data protection,
providing peace of mind.
This next generation In2itive delivers a simple,
modern user interface that builds on the high levels
of patient compliance (1,2) and quality of home
testing (3) of previous Vitalograph e-Diaries.
eCOA
• Configurable to your protocol requirements
to record symptom scores, medication use,
Patient Reported Outcomes and quality of
life questions for any therapeutic area
• Pre-validated for a comprehensive range of
eCOA/ePRO questionnaires
• Fully adaptable workflows to meet your
protocol requirements
• Fully customizable multiple subject alerts
• Date/time stamps ensure data integrity
• Compliant with FDA guidance on Patient
Reported Outcomes
• Updates for protocol amendments
implemented directly to In2itive
e-Diary devices
Patient Compliance
• High resolution touch screen display
• Simple, modern user interface
• Available in all languages with clear and bold fonts
• Training mode featuring text instructions and animated
help files which may be viewed by the patients at any time
• Continuous quality feedback, educating the patient from
test to test.
• In2itive e-Diary available with integrated or remote
flowhead options or e-Diary only where no respiratory
assessment required
Data you can rely on. People you can trust
Spirometry
• Fleisch Pneumotach provides diagnostic standards
of spirometry across both high and low rates
• Optional remote QA review of subject tests and
compliance feedback
• Ability to capture full flow-volume data and a wide
range of parameters in respiratory studies
• Direct feedback to the subject on PEF & FEV1 to
maximise data quality in respiratory studies
• Meets or exceeds ISO 23747 & ISO 26782
performance standards and ATS/ERS 2005
Recommendations
Security
• Dedicated, fully validated medical device to
comply with FDA cyber-security guidance (4)
• Locked down operating system without
unwanted apps, unvalidated updates or changes
• Encrypted data storage and transmission
• Individual patient logins
• Secure mirrored backups for protection of data
• Meets international EU & US data protection
requirements including FDA 21CFR Part 11 compliance,
with full audit trail of all user activity
PATIENT
Transmitted directly from patient's home
CLINIC
Clinic system with Spirotrac
Communications CENTRALIZED VITALOGRAPH
Centralized Data
• Built in Wi-Fi, Bluetooth® and Cellular modems STUDY DATA Management System
with secure IPSEC data tunnel
• Configurable by the site using either the Spirotrac®
Clinic System or through our dedicated Web Portal OVER-READERS
• Secure, encrypted data transfers Transmitted directly
• Real time access to study data
• Integrates with a single centralized database including
site spirometry, ECG, FeNO and other study data SPONSOR
Reports accessible via Web Portal
www.vitalograph.co.uk
Vitalograph is a world leading provider of outstanding quality
cardio-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.
Technical Specification Data Storage: Up to 10,000 tests
Input Voltage: 100 - 240V AC 50-60Hz,
Optional Modules/
Product Name: Handheld Spirometer Output Voltage: 5V DC Compatible Products
Product Variant: In2itive e-Diary Safety Standards: IEC 60601-1 Spirotrac for clinical trials
Model Number: 2120 EMC: IEC 60601-1-2
Net Size: 186mm x 81mm x 48mm Medical Devices Directive: 93/42/EEC
Gross Size: (packed device) 260mm x 125mm EU Class: IIa
Options
x 105mm. Gross Weight 600g Communications: Bluetooth 2.1 & 4, Handheld In2itive e-Diary with USB
Weight: 0.310 Kg Wi-Fi and Cellular Handheld In2itive e-Diary with Cellular
Measuring/Operating Principle: Fleisch Interface: Touch screen Bluetooth and Wi-Fi (available late 2017)
Pneumotachograph Validated Questionnaires:
Parameters: PEF, FEV1
Test types: Home use short expiration
ACQ, AQLQ, CAT, EXACT, EXACT-RS, ACT, AQ20,
EQ5D-3L, EQ5D-5L, LCQ
Spares and
Accuracy: Better than +/- 3% (Max 10L/ Min 0L);
Flows: Better than +/- 10% (Max 16L/s / Min
Consumables
Vitalograph provide the complete solution
0.02L/s) Linearity +/-5% in range 0.1 L/s to 16 L/s 36020 2040 Precision Syringe 3-L
for your eCOA needs, with the In2itive e-Diary
Environmental Data (use and storage): 28350 2820 BVF™ Bacterial/Viral Filters (50)
configured, managed and data collected through
Storage: 0°C - 50°C the use of Vitalograph Spirotrac systems at Clinic 40128 Plastic mouthpiece
Recommended Operating Range: 17°C - 37°C 83050 Flowhead complete
or through our Web Portal.
Ambient Humidity: 10% - 90% 83051 Carry bag
For eCOA service providers wishing to use the
Performance Standards: ISO 26782:2009; 83052 Device cap
In2itive e-Diary, Vitalograph can provide the
ISO23747:2015; ATS/ERS 2005
required API to provide seamless integration.
Battery type: Internal rechargeable
Please contact Vitalograph for further information.
battery 3.7v 900 mAH
Power Supply: PowerSAFE™ input 100-240V AC
50-60hz, output 5V 2A DC
References:
1. Harrison A, Sowman G: e-Diary compliance in a pharmaceutical trial; Eur Respir J 2009; S53: E1852
2. Harrison A, Watson E: e-Diary compliance in two pharmaceutical trials; Eur Respir J 2009; S53: E1854
3. Grant Sowman, Alison Wheatley, Joni Miller, Alison Scrimgeour, Beccy Trease, Neil Snowise: Quality of home Spirometry data in asthmatic patients
European Respiratory Journal 2013 42 (suppl 57): P1257
4. FDA Guidance – Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Oct 2014
FDA Guidance – Postmarket Management of Cybersecurity in Medical Devices: Dec 2016
Vitalograph Ltd, UK Vitalograph Ltd, International Vitalograph GmbH
Maids Moreton, Buckingham Maids Moreton, Buckingham Rellinger Straße 64a
MK18 1SW MK18 1SW D-20257 Hamburg
England England Germany
T: (01280) 827110 T: +44 1280 827120 T: +49 40 547391-0
F: (01280) 823302 F: +44 1280 823302 F: +49 40 547391-40
E: sales@vitalograph.co.uk E: sales@vitalograph.co.uk E: info@vitalograph.de
www.vitalograph.co.uk www.vitalograph.eu www.vitalograph.de
Vitalograph Inc Vitalograph (Ireland) Ltd Vitalograph Ltd, Hong Kong/China
13310 West 99th Street Gort Road Business Park Unit 2001, Floor 20, Block A
Lenexa, Kansas, 66215 Ennis, Co Clare New Trade Plaza
USA V95 HFT4 6 On Ping Street, Shatin
Toll Free: 800 255 6626 Ireland Hong Kong
T: (913) 730 3200 T: +353 65 6864100 T: +852 2117 2678
F: (913) 730 3232 F: +353 65 6829289 F: +852 2117 2679
E: vitcs@vitalograph.com E: sales@vitalograph.ie E: sales@vitalograph.cn
www.vitalograph.com www.vitalograph.ie www.vitalograph.cn
Vitalograph®, In2itive™, PowerSAFE™, BVF™ and Spirotrac® are trademarks or registered trademarks of Vitalograph Ltd.
Print Ref: 19988_1 Bluetooth® is a trademark of Bluetooth SIG. 0086
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