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Mytrus Confidential (Please Do Not Distribute) 1
Mytrus Confidential (Please Do Not Distribute).2
Mytrus Confidential (Please Do Not Distribute).3
Modernizing the consent process has big
advantages for patients, sponsors and sites.
Mytrus Confidential (Please Do Not Distribute).4
Patients are the focus of consent
Mytrus Confidential (Please Do Not Distribute).5
Mytrus Confidential (Please Do Not Distribute)6
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Q A4
Dr Smith
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Mytrus Confidential (Please Do Not Distribute)7
Device Distribution and Training
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Handles Versions and Amendments
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Mytrus Confidential (Please Do Not Distribute)9
Network Storage
Mytrus Confidential (Please Do Not Distribute)10
Sponsors Access Consent Data
Sponsor
Mytrus Confidential (Please Do Not Distribute)11
Project Teams Can Track ConsentActivity
Mytrus Confidential (Please Do Not Distribute).12
• US and International sites • Translations in multiple languages• Partnership with inVentiv Health allows reach in many countries
Mytrus Confidential (Please Do Not Distribute)13
ROI Opportunities....
• Much faster recruiting• Consent language learnings• Amendment management• Site management/selection• CRA oversight/remote monitoring• Risk calculations• Better patient retention Sponsor
That’s what I’m talking
about!
Mytrus Confidential (Please Do Not Distribute).
Validation Study Evidence!
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• Randomized trial @ Sutter Hospital in California• Measured recall of study details 24 hours after consent• 58% correct answers in Paper Group vs. 75% in iPad Group
58% 75%p=<.01 !
Mytrus Confidential (Please Do Not Distribute).
Recognition
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Mytrus Confidential (Please Do Not Distribute).16
Regulatory Support
“We support this novel approach.”“This is precedent setting.”
Reviewed by >30 additional local and academic IRBs
Mytrus Confidential (Please Do Not Distribute).
Regulatory Compliance:
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• IRBs consider eICF signature as synonymous to handwritten signature per 21 CFR Part 11
• Mytrus supports video capture and photo capture of consent where required by emerging regulations
• No PHI stored on devices • All data stored on off-site databases to comply with
HIPAA• Maintain security through mobile device management to
control all settings and physically locate device at all times
Mytrus Confidential (Please Do Not Distribute).18
Mytrus Confidential (Please Do Not Distribute).
Demo
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