IVR Clinical Concepts (www.ivrcc.com) is a technology company delivering patient registration, randomization and trial supply management (RTSM) and ePRO/eCOA via IVR/IMR/IWR for the electronic collection of patient/caregiver reported outcomes. The IVRCC System collects data as eSource and communicates in real-time seamlessly exchanging data with other eClinical Systems including OmniComm TrialMaster, Medidata RAVE and other EDC and CTM Systems. Much of the primary and secondary endpoint data for CNS, Behavioral Disorders, GI Disorders, and other therapeutics areas is collected from patient, caregiver and interviewer (Rater) reported outcomes. The overwhelming evidence is that collection of ePRO/eCOA data by electronic means vs. paper, combined with patient and site engagement reminders, results in more contemporaneous, complete, compliant and accurate data which is able to be accessed by study stakeholders in real-time.

1. WELCOME !
IVRCC Solutions
January, 2017

2. Agenda
• Introduction
• IVR Clinical Concepts Company History
• Product Services
• Reports, Notification, Exports
• Customer Care (Helpdesk)

3. IVRCC History & Timeline
2010
Administrative
& sales HQ in
NY, dedicated
IVRS staff in
Boca Raton, FL
continual system
and security
upgrades
Expand
mobile IMR
device
usability,
better user
interface, web-
hosting,
security
2013
2015
Continue
growth,
improvement
and client
education
1991 1996 2003 2004 2006 2007 2008 2009 2010 2013 2015
Expand to
IWRS, for
better subject
and trial staff
use
2009
2008
Acquire IVR
Concepts –
platform &
process
upgrades,
SOPs, security
improvements
IVR Clinical
concepts
incorporate,
FDA Guidance
accepting data
meeting ALCOA
specs
2007
2006
IVR Concepts, LLC,
interactive web
board for trial staff,
to enter patient
information, PINs,
inclusion/exclusion,
demographics,& for
EDC integration
Passive web
board - trial
personnel to
access their
subject activity
information
directly
2004
2003
Partnership with
Phone Interactive
Communications
Co. (PICC), a Boca
Raton, FL platform
and IVR service
provider.
Fax/IVR
integration,
alerts/
notifications
1996
1991
Trademark for
early iteration of
new solution,
TeleDiary™
ediary, for data
collection from
subjects
2017
Deploy mobile
site tablets for
Rater evaluation,
continued
enhancement of
patient
engagement
2016
2016

4. Core Competencies of IVRS-IWRS
Screening,
Registration,
Randomization
CTM
Management
eCOA, ePRO eIntegration
• Subject Recruitment, Screening, Registration, Randomization
• Clinical Trial Material (drug-device) Supply, Dispensation
– Inventory Management, Accountability
• Electronic Clinical Outcomes Assessments (eCOA) & Electronic
Subject Reported Outcomes (ePRO)
• Integration with Electronic Data Capture (EDC), Clinical Trial
Management Systems (CTMS), other electronic systems, etc.
• Standard and custom Reporting, Notifications - alerts, Data
Exports
Reporting
Notifications
Data Exports

5. IVRCC’s: IVRS-IWRS Features
• Extensive Clinical Study Experience, IVR/IWR custom coding, with fast
deployments
• PIN and passcode secured, secure hosting and advanced security
protocols, SSL encrypted communication protocol and 21CFR part11 &
HIPAA compliant
• SaaS - No software maintenance, or programming by client
• Support BYOD - No proprietary hardware investment: telephones,
computers, mobile devices
• Redundancy (IP, servers, facilities), tested and proven backup systems and
protocols, strategically co-located carrier facilities
• Scripts translated into virtually any written and spoken languages/dialects
• IVRS: Large simultaneous call volume capacity, international and toll-free
24/7/365 subject access via phone, or cell phone, skype
• IWRS: Scalable, access via virtually all internet connected devices -
PCs/Macs, IE, Chrome, Firefox, Safari etc. browsers, with website formatting
for smartphones and tablets, iOS and Android

6. Randomization

7. Randomization
95% of studies include randomization
• Single randomization
list for entire study
• Randomization list by
country
• Randomization list by
site
• Randomization
stratified by location,
gender, level of
condition, age, etc.
• Minimization
techniques
• Custom/Client specific
algorithms
• Experience with
dynamic technique
• Other, e.g. Sequential
Parallel Comparison
Design (SPCD):
Blocked
Randomization
Stratification
Dynamic
Randomization
Coordinate
with CTM
Dispensation
Multiple Factors Desired Balance Assign Treatment
Coordinate
real-time, data
exchange with EDC

8. CTM Management &
Accountability
Clinical Trial Material Management: Device/Drug

9. CTM Management Services
Manage, track and report
• Release initial supply allotments of study materials to activated sites
• Multiple supply models and management at central, regional and site inventories
• Project inventory needs per supply timelines and level of activity in different
countries, sites
• Inventory availability following shipment and treatment allocation
• Dispensing and titration management, accommodating real-time parameters,
investigator determinations, previous treatments and branched subject response
entries, adaptive trials
• On Demand Reports, real-time notifications appropriate to user categories
• Reviews and actions based on Expiry dates/product recall
• Continuous human intervention oversight provided by IVRCC staff
• On Demand Unblinding/Emergency Code Break system for restricted users
• Provide Clinical Trials Supply Management and Integration with other CTMS
applications

10. CTM Accountability
Distribution Depot to Depot
Depot to site
Dispensation Subject randomization
and pack allocation
Accountability Subject dispensing
and return documentation
Reconciliation Review and confirmation
of accountability data
Returns Management of return
shipments
Destruction Destruction confirmation
Clinical Trial Material supply management
system tracks from central to multiple
regional depots to point of allocation to a
subject.
CTM Accountability system picks up at this
point and tracks back from a subject until
final resolution of CTM is completed.

11. ePRO
Electronic Patient Reported Outcomes

12. ePRO and Subject Data
Many Types of Information
• Medication Compliance
• Time/Date of events
• Modality (voice/web) Preferences
• Quality of Life (QoL)
– Mood
– Ability to perform certain
physical/cognitive tasks
• Self Reported Symptoms
• Work and Productivity
• Efficacy of CTM
• Subject Satisfaction
• Safety Side effects
Validated Instruments and
Novel Questionnaires
• Numeric Scales
• YES/NO Questions
• Multiple Choice
• Verbal Rating Scales
• Visual Analog Scales (VAS)
• Free text
• Body Diagrams
• Dynamic Branching
• Rater Evaluations
• ….and more

13. ePRO: Therapeutic Areas of Experience
Asthma Allergy
Attention Deficit
Hyperactivity Disorder Bronchitis
Constipation Depression Gastroparesis GERD
HIV+
(young men)
Hypertension Insomnia
Irritable bowel
syndrome
Migraine Oncology Osteoarthritis
Overactive
bladder
Parkinson’s
disease
Pneumonia
Sexual
dysfunction
Ulcerative colitis
Venous
thrombosis
Women’s health

14. ePRO: Compliance Case Studies
Indication
Reporting
Frequency
Calling
Period
Compliance
Number of
Patients
Allergic Rhinitis Twice Daily 3 Weeks 88% 901
Migraine Daily 26 Weeks 95% 47
Allergic Rhinitis Twice Daily 3 Weeks 92% 862
Hormone Replacement
Therapy
Daily 16 Weeks 90% 1134
Von Willebrand’s
Disease
PRN/Once per Month 1 Year 93% 389
Pain Daily 4 Weeks 92% 365
ePRO Validation Studies Daily 2 Weeks 96% 160

15. ePRO: Laptop or PC or Mac

16. ePRO: Apple IPhone Smartphone

17. ePRO: Samsung Android Smartphone

18. ePRO: Apple IPad or Samsung Tablet

19. Reporting, Notifications &
Exports

20. Scheduled, or on
demand
• Entire data-
base, or partial,
data, metadata
• End of study
final archive
available for
Sponsor, CRO
and sites, by
permission
• Electronic File
• Burnt to CD
Reporting, Notification, Exports
Real-time tracking via
the web
• Standard and
custom designed for
each study
• Reporting details
according to users’
assigned role-based
permissions
• Viewable, sortable &
filterable,
downloadable,
printable, exportable
to Excel
Reports
Confirmation of an
event, or NON-
event
• Fax, text, phone
call and/or email
– to site, medical
monitor, CRA,
study manager
even ePRO
subjects
• Occur as the result
of any study event
– Randomization
confirmation
– Supply shipment
– Supply reorder
– Diary reminder
– Lack of diary
compliance
Notifications
Fax and/or email
• Status reporting,
scheduled for run
at pre-defined time
intervals (daily,
weekly, monthly)
and sent via FAX
or Email
− Cumulative subject
or site tracking
information
− Projections
− Custom Reporting
Batch Reports Exports

21. Study Snapshot Chart
Site Enrollment Status Report
Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007

22. Study Snapshot Graphs
Registrations Report
Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007

23. Study Snapshot Chart & Graph
Subject Status - Randomization Report
Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007

24. Study Snapshot Chart
Client Subject Status and Diary Compliance Report
Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007

25. Study Snapshot eMail
Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007
From: IVRCC Snapshot [mailto: @ivrcc.com]
Sent: Tuesday, August 20, 2013 10:05 AM
To: Nancy Hudak
Subject: - Study Snapshot - Week 18 of enrollment
Attached is the study snapshot report for the study.
Feasibility of a Using a Structured Daily Diary to Assess…
Enrollment started on April 16, 2013 with target enrollment of 90 subjects in 72
weeks.
At current enrollment rate of 2.00 subjects per week, it is estimated to enroll the
remaining 55 subjects in 27 weeks, February 2014
At best enrollment rate of 7.00 subjects per week, it is estimated to enroll the
remaining 55 subjects in 11 weeks, November 2013

26. Study Snapshot
Enrollment Report
Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007
HIV-positive Young MSM

27. Study Snapshot
Site Summary and Diary Compliance
Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007

28. Subject Status
Subject Status and Forecasting Graph
Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007

29. Registration Notification eMail
Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007

30. Subject Detail
Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007

31. Subject Diary History with Payments
Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007
Diary History
Modality Day Date Progress
Incomp
lete
Section
Closed
Compens
ation
Bonus Lottery
Reason for
Missed Diary
Web 1 05/15/13 Complete 16-May 03:12 $2.00
Web 2 05/16/13 Not Started 17-May 08:30 $0.00
Web 3 05/17/13 Complete 18-May 00:46 $2.00 3
Web 4 05/18/13 Complete 19-May 01:19 $2.00 $25.00
Web 5 05/19/13 Complete 19-May 23:48 $2.00
Web 6 05/20/13 Complete 21-May 02:32 $2.00
Web 7 05/21/13 Complete 21-May 23:40 $2.00
Web 8 05/22/13 Complete 23-May 00:57 $2.00
Web 9 05/23/13 Complete 24-May 00:05 $2.00 $5.00
Web 10 05/24/13 Complete 25-May 02:30 $2.00
Web 11 05/25/13 Complete 26-May 00:37 $3.00
Web 12 05/26/13 Complete 27-May 01:48 $3.00
Web 13 05/27/13 Complete 27-May 22:22 $3.00
Web 14 05/28/13 Complete 28-May 23:36 $3.00
Web 15 05/29/13 Complete 30-May 00:46 $3.00 $5.00
Web 16 05/30/13 Complete 30-May 23:18 $3.00
Web 17 05/31/13 Complete 01-Jun 00:46 $3.00
Web 18 06/01/13 Complete 02-Jun 01:57 $4.00 $5.00
Web 19 06/02/13 Complete 03-Jun 01:08 $4.00
Web 20 06/03/13 Complete 04-Jun 00:30 $4.00 $5.00
Web 21 06/04/13 Complete 05-Jun 00:29 $4.00
Web 22 06/05/13 Complete 05-Jun 21:27 $4.00
Web 23 06/06/13 Complete 07-Jun 00:06 $4.00
Web 24 06/07/13 Complete 07-Jun 21:46 $4.00
Web 25 06/08/13 Incomplete E 09-Jun 08:30 ($1.00)
Web 26 06/09/13 Complete 10-Jun 01:03 $5.00 7
Web 27 06/10/13 Complete 11-Jun 01:34 $5.00
Web 28 06/11/13 Complete 12-Jun 02:58 $5.00
Web 29 06/12/13 Complete 12-Jun 20:10 $5.00
Web 30 06/13/13 Complete 14-Jun 00:14 $5.00
Diary History – Subject 10407

32. Diary Compliance Grid
Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007
Close
Site:
All Sites
Subject: Modality:
(All)
Modality #:
(All)
Subject Modality # Started 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33
10401 Phone 1 04/16/2011
10401 Web 2 05/21/2011
10402 Phone 1 04/30/2011
10403 Web 1 04/30/2011
10404 Web 1 05/02/2011
10405 Web 1 05/08/2011
10405 Phone 2 06/10/2011
10406 Web 1 05/15/2011
10406 Phone 2 06/17/2011
10407 Phone 1 06/05/2011
10407 Web 2 07/08/2011
10408 Phone 1 06/05/2011
10408 Web 2 07/09/2011
10409 Phone 1 06/17/2011
10410 Web 1 06/24/2011
10411 Web 1 06/25/2011
10412 Phone 1 06/27/2011
10413 Phone 1 07/03/2011
11901 Phone 1 06/14/2011
11902 Web 1 06/17/2011
11903 Phone 1 06/18/2011
11904 Web 1 06/18/2011
11905 Phone 1 06/19/2011
11906 Web 1 06/21/2011
12201 Web 1 05/15/2011
12201 Phone 2 06/17/2011
12202 Phone 1 06/24/2013
Legend:
= Completed diary = Missed diary = Premature discontinued

33. Daily Diary Compliance eMail
Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007
Good Morning Site 4 - Philadelphia,
The following subjects did not record a diary for yesterday, Sunday, July 14.
Subject Mode Diary Status
10407 Web Not Started
10408 Web Not Started
Regards,
IVRCC Team
IVR Clinical Concepts, Inc  Business Office: 358 Broadway, Suite 201  Saratoga Springs, NY
12866  Office: 561-391-9686  Website: www.ivrcc.com
LEGAL: This e-mail, including attachments, may include confidential and/or proprietary information, and may be used only by the person or entity to which it is
addressed. If the reader of this e-mail is not the intended recipient or his or her authorized agent, the reader is hereby notified that any dissemination, distribution
or copying of this e-mail is prohibited. If you have received this e-mail in error, please notify the sender by replying to this message and delete this e-mail
immediately.

34. Cumulative Diary Compliance eMail
Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007
Good Day Study Staff,
This is notification of your subject's expected diary dosing calls as of June 28, 4:00 AM. Please review for action
that you may need to take to remind your subjects to record their dosing information for yesterday.
Subject Initials DOB Visit 2 Last Dose Date Diary Calls Made Diary Calls Expected
003-026 J-R 12-Dec-1979 09-May-2012 29-May-2012 20 50
003-063 J-G 08-Jan-1991 31-May-2012 31-May-2012 1 28
003-067 JJR 13-Jan-1986 07-Jun-2012 25-Jun-2012 18 21
003-071 GEM 27-Sep-1988 07-Jun-2012 26-Jun-2012 21 21
003-076 AJF 11-Oct-1989 07-Jun-2012 21-Jun-2012 10 21
Kind Regards,
IVRCC Support
IVR Clinical Concepts, Inc  Business Office: 358 Broadway, Suite 201  Saratoga Springs, NY 12866  Office: 561-391-
9686  Website: www.ivrcc.com

35. SMS Text Reminders
Standard and Customized Client Reports
Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007

36. Telephone Metadata
Standard and Customized Client Reports
Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007

37. Customer Care

38. Customer Care (Help Desk)
• Global staff: New York, California, Florida, Canada, Europe, South Africa,
India, Russia, Israel, and Trained Partner staff as needed: (e.g., Australia)
• Toll-free Phone: Helpdesk for 24/7/365 coverage International, or Country
phone number as needed.
– Live 8 am - 8 pm EST
– 8 PM - 8 AM via smartphone with 15 min. guaranteed turn around time
• Email Help Desk: 30 minutes during, or after start of next work day
• Ticket system: for tracking through resolution
– Prioritize issues: based upon Severity level 1 Critical (recommend phone
contact), 2 High, 3 Standard
• Auto reset: Password & User i.d.s (85% of issues)
• Online FAQ information: standard and customized per protocols

39. Thank You
IVRCC collected data enables better scientific conclusions because the
data is valid and trustworthy to regulatory authorities, which may prove
to be the difference between an approval and a request for more data
IVRCC— Providing Effective and Innovative Solutions for
Optimizing Clinical Trial Management