The hybrid virtual approach: replacing on-site clinic visits with Virtual Visits using THREAD. Presented at DPharm on 24Sep2018 for Mobile in Clinical Trials.

1. THREAD CONFIDENTIAL
The Hybrid Virtual Approach:
Replacing On-site Clinic Visits with Virtual Visits
Mobile in Clinical Trials Conference at DPharm
Boston, MA • 24 Sep 2018

2. THREAD CONFIDENTIAL
Three (3) different virtual approach models to enable remote research
The CRAWL, WALK, RUN
of Virtual Research

3. T HREADresea rc h.c om
Crawl: Remote Patient Research
On-Site Visit
collect study data in between on-site visits
On-Site Visit

4. T HREADresea rc h.c om
On-Site Visit On-Site Visit
Crawl: Remote Patient Research
collect study data in between on-site visits

5. T HREADresea rc h.c om
On-Site Visit On-Site VisitOn-Site Visit
Crawl: Remote Patient Research
collect study data in between on-site visits

6. T HREADresea rc h.c om
On-Site Visit On-Site VisitOn-Site VisitOn-Site Visit On-Site Visit
Crawl: Remote Patient Research
collect study data in between on-site visits

7. T HREADresea rc h.c om
On-Site Visit Virtual Visit
Walk: Virtual Hybrid Study
replace some on-site visits with Virtual Visits

8. T HREADresea rc h.c om
Virtual Visit Virtual Visit
Run: Fully Virtual Study
all visits are Virtual Visits

9. THREAD CONFIDENTIAL
What is a Virtual Visit?
The makeup of a hybrid virtual approach

10. T HREADresea rc h.c om
Site Experience Patient Experience
Virtual Visits
Telehealth
eConsent
eSource
ePRO
Medical Device
Survey
Virtual Visit

11. T HREADresea rc h.c om
Patient and Site
Virtual Engagement
Capture Method Assessment
eConsent Consent
Telehealth + eSource Modified Physical Exam
Telehealth + eSource Adverse Event Reporting
ePRO Quality of Life
Medical Device Glucose Reading
Survey Patient Satisfaction
Virtual Visits
Video
Conference
Activity
Completion

12. THREAD CONFIDENTIAL
Three (3) steps to confirm the best candidates for a Virtual Visit
How Do I Convert On-site Visits
to Virtual Visits?

13. T HREADresea rc h.c om
Assessment Screening Baseline Week 2 Week 4 Month 2 Month 3 Month 6 Month 12 Month 18 Month 24 /
FINAL
Informed Consent and HIPAA X
Inclusion/Exclusion Criteria X
Demographic Information X
Medical History X
Concomitant Medications X X X X X X X X X
Physical Exam X
Modified Physical Exam X X
AE / SAE X X X X X X X X X
12-Lead EKG X X X X
MRI X X X
Activity, Sleep and Fall Frequency X X X X X X X X X
Study Specific Labs X X X X
Clinician Rated Observation X X X
Condition Specific ePRO X X X X X X X X
Pulmonary Function Tests X X X X X X X
Quality of Life ePRO X X X X X X
Patient Satisfaction Survey X X X X
x Not Virtual Visit Ready
1 Confirm Assessments that are “Not Virtual Visit Ready”
Protocol Schedule of Events (example assessments only)

14. T HREADresea rc h.c om
Assessment Screening Baseline Week 2 Week 4 Month 2 Month 3 Month 6 Month 12 Month 18 Month 24 /
FINAL
Informed Consent and HIPAA X
Inclusion/Exclusion Criteria X
Demographic Information X
Medical History X
Concomitant Medications X X X X X X X X X
Physical Exam X
Modified Physical Exam X X
AE / SAE X X X X X X X X X
12-Lead EKG X X X X
MRI X X
Activity, Sleep and Fall Frequency X X X X X X X X X
Study Specific Labs X X X
Clinician Rated Observation X X X
Condition Specific ePRO X X X X X X X X
Pulmonary Function Tests X X X X X X X
Quality of Life ePRO X X X X X X
Patient Satisfaction Survey X X X X
x Not Virtual Visit Ready
2 Confirm Assessments that are “Virtual Visit Ready”
Protocol Schedule of Events (example assessments only)
Virtual Visit Readyx

15. T HREADresea rc h.c om
Assessment Screening Baseline Week 2 Week 4 Month 2 Month 3 Month 6 Month 12 Month 18 Month 24 /
FINAL
Informed Consent and HIPAA X
Inclusion/Exclusion Criteria X
Demographic Information X
Medical History X
Concomitant Medications X X X X X X X X X
Physical Exam X
Modified Physical Exam X X
AE / SAE X X X X X X X X X
12-Lead EKG X X X X
MRI X X X
Activity, Sleep and Fall Frequency X X X X X X X X X
Study Specific Labs X X X X
Clinician Rated Observation X X X
Condition Specific ePRO X X X X X X X X
Pulmonary Function Tests X X X X X X X
Quality of Life ePRO X X X X X X
Patient Satisfaction Survey X X X X
x Not Virtual Visit Ready
3 Confirm Visits that are “Virtual Visit Ready”
Protocol Schedule of Events (example assessments only)
Virtual Visit Readyx

16. THREAD CONFIDENTIAL
Therapeutic areas and study phases that are best suited for Virtual Visits
What Studies are Best Suited
for Virtual Visits?

17. T HREADresea rc h.c om
THERAPEUTIC AREAS
C A R D I O V A S C U L A R /
M E T A B O L I C
C N S D E R M A T O L O G Y
O P H T H A L M O L O G Y
E N D R O C R I N O L O G Y &
M E T A B O L I C D I S E A S E
G A S T R O E N T E R O L O G Y P A I N M A N A G E M E N T I N F E C T I O U S
D I S E A S E S
V A C C I N E &
V I R O L O G Y
R E S P I R A T O R Y
& I M M U N O -
I N F L A M M A T O R Y
O N C O L O L O G Y
Phase II, III and IV studies

18. THREAD CONFIDENTIAL
Technology platform features required in combination to enable Virtual Visits
What Technology Features are
Required for Virtual Visits?

19. T HREADresea rc h.c om
ePRO
ClinRO
eSource
Patient Engagement
Patient Authentication
eConsent
Telehealth
Site Portal
Sensors
Compliant Cloud
Virtual Visit Technology Features
Patient and Site
Virtual Engagement
Video
Conference
Activity
Completion

20. THREAD CONFIDENTIAL T HRE AD rese arc h.c om
Learn more about Virtual Visits
www.threadresearch.com/walk
THREAD CONFIDENTIAL
This document contains trade secrets or otherwise confidential information owned by THREAD. Access to and use of this
information is strictly limited and controlled by THREAD. This document may not be copied, distributed, or otherwise disclosed
outside of THREAD’s facilities except under appropriate precautions to maintain the confidentiality hereof, and may not be
used in any way not expressly authorized by THREAD.
©THREAD 2018. All rights reserved.